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1. Safety and Efficacy of Subretinally Administered Palucorcel for Geographic Atrophy of Age-Related Macular Degeneration

Author

John W. Kitchens, Yannek I. Leiderman, Rand Spencer, Michael A. Samuel, George A. Williams, Allen C. Ho, James Baldassarre, Michael F. Keane, Tom S. Chang, Jeffrey S. Heier, Christopher D. Riemann, Sheila B Hickson-Curran, and Jason S. Slakter

Subjects
0303 health sciences, medicine.medical_specialty, Intraocular pressure, Visual acuity, genetic structures, business.industry, Conjunctival Hemorrhage, Perforation (oil well), Glaucoma, Retinal detachment, Macular degeneration, medicine.disease, eye diseases, 03 medical and health sciences, Ophthalmology, 0302 clinical medicine, 030221 ophthalmology & optometry, medicine, sense organs, medicine.symptom, business, Adverse effect, 030304 developmental biology
Abstract

Purpose To evaluate safety and successful use of a novel subretinal delivery system and suprachoroidal surgical approach and safety and activity of human umbilical tissue–derived cells (palucorcel) via a novel delivery system in patients with geographic atrophy (GA). Design Multicenter, open-label phase 2b study. Participants Participants were 55 to 90 years with GA secondary to age-related macular degeneration (AMD) and best-corrected visual acuity (BCVA) of 20/80 to 20/800. Exclusion criteria included neovascular AMD in the intervention eye, glaucoma with intraocular pressure of 25 mmHg or more, or other significant ophthalmologic conditions. Methods Participants received a subretinal injection of palucorcel, 3.0 × 105 cells in 50 μl, using the custom-designed delivery system and surgical procedure. Main Outcome Measures Safety assessments included treatment-emergent adverse events (AEs), immunologic assessments, and ophthalmologic evaluations. Efficacy was evaluated as change in mean number of BCVA letters from baseline, proportion of participants gaining 15 BCVA letters or more, and growth rate of GA lesions at 12 months. Results Surgery and palucorcel administration were performed in 21 participants at 8 sites by 8 different surgeons. At baseline, median total area of GA was 13.4 mm2 and median BCVA was 43 letters in the intervention eye. Eye-related AEs occurred in 76% of participants (16/21), including conjunctival hemorrhage (n = 5), retinal hemorrhage (n = 4), and vitreous floaters (n = 4). Most AEs were mild and resolved within 1 month. No serious AEs, no retinal detachment or perforation, and no significant changes in intraocular pressure occurred. At month 12, mean change in BCVA from baseline was –5.9 letters correct (standard deviation, 13.0 letters correct) in the intervention eye and –3.7 letters correct (standard deviation, 9.0 letters correct) in the fellow eye. No participants showed improvement of 15 letters or more in the intervention eye, and 3 participants lost more than 15 letters by month 1. No apparent effect of treatment was observed. Conclusions Palucorcel was delivered successfully to the targeted subretinal site using a novel delivery system and suprachoroidal approach for most participants; however, improvement in GA area, retardation of growth, or visual acuity were not demonstrated.

Published
2020
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2. Intravitreal Combined Aflibercept + Anti–Platelet-Derived Growth Factor Receptor β for Neovascular Age-Related Macular Degeneration

Author

Robert Vitti, Friedrich Asmus, Karen W. Chu, Jeffrey S. Heier, Sunil S. Patel, Sergio Leal, David M. Brown, John W. Kitchens, Thomas Schmelter, Lorah Perlee, Charles C. Wykoff, Vladimir Son, and Nadia K Waheed

Subjects
0303 health sciences, medicine.medical_specialty, Visual acuity, business.industry, Incidence (epidemiology), Macular degeneration, medicine.disease, law.invention, 03 medical and health sciences, Ophthalmology, 0302 clinical medicine, Pharmacotherapy, Randomized controlled trial, law, 030221 ophthalmology & optometry, medicine, Clinical endpoint, medicine.symptom, Adverse effect, business, 030304 developmental biology, Aflibercept, medicine.drug
Abstract

Purpose To compare the efficacy and safety of intravitreal aflibercept + anti–platelet-derived growth factor receptor β (PDGFRβ) combination with intravitreal aflibercept injection (IAI) monotherapy in patients with treatment-naive neovascular age-related macular degeneration (nAMD). Design Phase 2, randomized, double-masked study. Participants A total of 505 patients (eyes) with nAMD. Methods Patients were randomized 1:2:2 to low-dose combination intravitreal anti-PDGFRβ 1 mg and aflibercept 2 mg (LD combo), high-dose combination intravitreal anti-PDGFRβ 3 mg and aflibercept 2 mg (HD combo), or IAI alone every 4 weeks through week 12. At week 12, patients in the HD combo and IAI groups were re-randomized to continue as assigned or switch to HD combo → IAI or IAI → HD combo and dosed every 4 weeks through week 28. During weeks 28 to 52, patients received treatment as needed per prespecified criteria. This report presents efficacy through week 28 and safety through week 52. Main Outcome Measures Mean best-corrected visual acuity (BCVA) change from baseline at week 12 (primary end point). Results At week 12, mean BCVA gains from baseline were 5.8, 5.8, and 7.5 letters with LD combo, HD combo, and IAI, respectively (P = 0.21 for LD combo and P = 0.10 for HD combo vs. IAI). The corresponding proportions of eyes that gained ≥15 letters were 12%, 19%, and 22%, respectively. Mean reductions in central retinal thickness from baseline were 126.1, 127.1, and 126.9 μm, respectively. Proportions of eyes with complete resolution of fluid from baseline were 35%, 24%, and 42%, respectively. Vision and anatomic outcomes at week 28 were consistent with the week 12 results. Through week 52, the incidence of intraocular inflammation was 1.0%, 7.5%, 2.1%, 2.1%, and 0%, respectively. The incidence of Anti-Platelet Trialists’ Collaboration–defined arterial thromboembolic events was 1.9%, 0.9%, 1.1%, 2.1%, and 1.9%, respectively. Conclusions Intravitreal aflibercept + anti-PDGFRβ did not improve BCVA over IAI alone. Anatomic outcomes evaluating complete fluid resolution favored IAI. Adverse events were consistent with the reported IAI safety profile, except for a higher frequency of intraocular inflammation in the HD combo group.

Published
2020
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3. Outcomes and Practice Preferences After Endophthalmitis Following Anti-VEGF Intravitreal Injection

Author

Ryan J. Whitted, Tavé van Zyl, Kevin J. Blinder, Ananda Kalevar, Carl D. Regillo, John S. Pollack, Asheesh Tewari, Gaurav K. Shah, Lawrence J. Singerman, Abdallah Jeroudi, Jonathan Hu, Charles C. Wykoff, Dean Eliott, Mahdi Rostamizadeh, J. Michael Jumper, Anthony Joseph, Brett M. Weinstock, Musa Abdelaziz, Anthony P. Leonard, Marina Gilca, John W. Kitchens, Yicheng Chen, Vaishali Shah, Rui Wang, Bobeck S. Modjtahedi, Gregory D. Lee, and Jeffrey S. Heier

Subjects
Anti vegf, medicine.medical_specialty, business.industry, Growth factor, medicine.medical_treatment, Diabetic macular edema, Vitreoretinal surgery, medicine.disease, 03 medical and health sciences, Retinal neovascularization, 0302 clinical medicine, Endophthalmitis, Choroidal neovascularization, Central retinal vein occlusion, Ophthalmology, 030221 ophthalmology & optometry, medicine, 030212 general & internal medicine, medicine.symptom, business
Abstract

Purpose:This study examines treatment-based outcomes of endophthalmitis due to antivascular endothelial growth factor (anti-VEGF) intravitreal injection and its effect on subsequent management of neovascular disease.Methods:A retrospective multicenter study was conducted of 157 patients with a diagnosis of endophthalmitis following anti-VEGF intravitreal injection at 10 major ophthalmic centers.Results:The median number of injections before endophthalmitis was 10 (range, 1 to 84 injections). Initial treatment with tap and inject with or without subsequent vitrectomy trended toward smaller visual acuity changes from baseline (4 ETDRS [Early Treatment Diabetic Retinopathy Study] letter difference vs 19 ETDRS letter difference) compared with initial vitrectomy, but the difference was not statistically significant. There was no significant change in medication choice among injections after endophthalmitis. There was a statistically significant shift away from regular interval (1- to 2-month) injections and a shift toward treat-and-extend and as-needed injection algorithms.Conclusions:The visual outcomes were not significantly different between patients who initially underwent tap and injection of antibiotics and those who underwent vitrectomy. There was no significant change in medication choice before and after endophthalmitis but there was a shift toward lower-frequency injection algorithms after postintravitreal injection endophthalmitis compared with prior.

Published
2019
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4. Natural History of Drusenoid Pigment Epithelial Detachment Associated with Age-Related Macular Degeneration

Author

Jeannette J. Yu, Elvira Agrón, Traci E. Clemons, Amitha Domalpally, Freekje van Asten, Tiarnan D. Keenan, Catherine Cukras, Emily Y. Chew, Frederick L. Ferris, John Paul SanGiovanni, Traci Clemons, Anne Lindblad, Robert Lindblad, Nilay Shah, Robert Sperduto, Wendy McBee, Gary Gensler, Molly Harrington, Alice Henning, Katrina Jones, Kumar Thotapally, Diana Tull, Valerie Watson, Kayla Williams, Christina Gentry, Francine Kaufman, Chris Morrison, Elizabeth Saverino, Sherrie Schenning, Barbara Blodi, Ronald P. Danis, Matthew Davis, Kathy Glander, Gregory Guilfoil, Larry D. Hubbard, Kristine Johnson, Ronald Klein, Barbara Nardi, Michael Neider, Nancy Robinson, Eileen Rosensteel, Hugh Wabers, Grace Zhang, Alan J. Ruby, Antonio Capone, Bawa Dass, Kimberly Drenser, Bruce R. Garretson, Tarek S. Hassan, Michael Trese, George A. Williams, Jeremy Wolfe, Tina Bell, Mary Zajechowski, Dennis Bezaire, Fran McIver, Anthony Medina, Jackie Pagett, Stephanie Hatch Smith, Lynn Swartz, Tom Treuter, Andrew Antoszyk, Justin Brown, David J. Browning, Walter Holland, Angella Karow, Kelly Stalford, Angela Price, Sarah Ennis, Sherry Fredenberg, Jenna Herby, Uma Balasubramaniam, Loraine Clark, Donna McClain, Michael McOwen, Lynn Watson, Michael Klein, Steven T. Bailey, Thomas J. Hwang, Andreas Lauer, J. Timothy Stout, Patty McCollum, Milt Johnson, Patrick B. Rice, Ivana Kim, John Loewenstein, Joan Miller, Lucia Sobrin, Lucy Young, Jacqueline Sullivan, Patricia Houlihan, Linda Merry, Ann Marie Lane, Ursula Lord Bator, Claudia Evans, Sarah Brett, Charleen Callahan, Marcia Grillo, David Walsh, Kamella Lau Zimmerman, Gary Edd Fish, Rajiv Anand, Lori E. Coors, Dwain G. Fuller, Rand Spencer, Robert C. Wang, Karen Duignan, Sally Arceneaux, Hank Aguado, Nicholas Hesse, Michael Mackens, Brian Swan, Wai T. Wong, Monica Dalal, Naima Jacobs-El, Catherine Meyerle, Benjamin Nicholson, Henry Wiley, Katherine Hall Shimel, Angel Garced, Janice Oparah, Greg Short, Alana Temple, Babilonia Ayukawa, Guy Foster, Darryl Hayes, Dessie Koutsandreas, Roula Nashwinter, John Rowan, Michael Bono, Denise Cunningham, Marilois Palmer, Alicia Zetina, David H. Orth, Kourous Rezaei, Joseph Civantos, Sohail Hasan, Kirk Packo, Celeste Figliulo, Pam Stanberry, Tara Farmer, Kiersten Nelson, Shannya Townsend-Patrick, Philip Rosenfeld, Royce Chen, Rishi Doshi, Sander Dubovy, Brian T. Kim, Matthew Lowrance, Andrew Moshfeghi, Zayna Nahas, Gary Schienbaum, John Vishak, Christina Weng, Zohar Yehoshua, Belen Rodriguez, Jose Rebimbas, Jane Gleichauf, Mike Kicak, Jason Mena, Tim Odem, Elizabeth Sferza-Camp, Alicia Disgdiertt, Jim Oramas, Isabel Rams, Stephanie Thatcher, Susan B. Bressler, Neil M. Bressler, Daniel Finkelstein, Steven H. Sherman, Sharon Solomon, Howard S. Ying, Rita Denbow, Deborah Phillips, Elizabeth Radcliffe, Judy Belt, Dennis Cain, David Emmert, Mark Herring, Jacquelyn McDonald, G. Baker Hubbard, Chris S. Bergstrom, Blaine Cribbs, Andrew Hendrick, Brandon Johnson, Philip Laird, Sonia Mehta, Timothy Olsen, Justin Townsend, Jion Yan, Steven Yeh, Linda Curtis, Judy Brower, Hannah Yi, Jannah Rutter Dobbs, Debbie Jordan, Michael J. Elman, Robert A. Liss, JoAnn Starr, Jennifer Belz, Charlene Putzulo, Teresa Coffey, Ashley Davis, Pamela Singletary, Giorya Shabi Andreani, Theresa Cain, Daniel Ketner, Peter Sotirakos, Suresh Chandra, Barbara A. Blodi, Michael M. Altaweel, Justin L. Gottlieb, Michael Ip, T. Michael Nork, Thomas S. Stevens, Kathryn Burke, Shelly Olson, Kristine Dietzman, Barbara Soderling, Guy Somers, Angie Wealti, Denise Krolnik, John Peterson, Sandra Reed, Thomas Friberg, Andrew Eller, Denise Gallagher, Leanne Labriola, Melissa Pokrifka, Aron Gedansky, Natalie Anthony, Cassandra Grzybowski, Dawn Matthews, Sharon Murajda-Jumba, Jessica Toro, David G. Callanan, Wayne A. Solley, Patrick Williams, Sandy Lash, Bob Boleman, Chris Dock, Michel Shami, Brenda Arrington, Ashaki Meeks, Alan R. Margherio, Paul Raphaelian, Debra Markus, Justin Langdon, Elizabeth Truax, Sandy Lewis, Brad Terry, Amy Noffke, Kean Oh, Ramin Sarrafizadeh, Scott Sneed, Julie Hammersley, Serena Neal, Mary Doran, Nan Jones, Lisa Preston, Heather Jessick, Tanya Tracy Marsh, Michael Tolentino, Adam Berger, Richard Hamilton, David Misch, Suk Jin Moon, Dawn Sutherland, Vera Dilts, Sara Henderson, Esmeralda Medina, Donald Trueman, Laura Holm, Jason Strickland, Darmakusuma Ie, Jeffrey L. Lipkowitz, Kekul B. Shah, Susan Geraghty, Beverly Sannazzaro, Morgan Harper, Krista Bayer, Mary B. Lansing, Lauren B. Fox, Rebecca Lee, Jay B. Stallman, Michael Jacobson, Sean Koh, Scott Lampert, John Miller, Mark Rivellese, Atul Sharma, Robert A. Stoltz, Stephanie Vanderveldt, Leslie Marcus, Starr Hendricks, Ryan Hollman, Grethel Betanzos, Leslie Ellorin, Shelly Fulbright, Debbie McCormick, Paul A. Edwards, Julianne Hall, Mary Monk, Melanie Gutkowski, Melina Mazurek, Janet Murphy, Katherine Gusas, Crystal Moffett, David Burley, Nicole Chesney, Katie Kilgo, Brian Rusinek, Bradley Stern, Tracy Troszak, Rhonda Baker-Levingston, Carl W. Baker, Tracey Caldwell, Tammy Walker, Lynnette F. Lambert, Tracey Martin, Mary Jill Palmer, Tana Williams, Michael A. Novak, Joseph Coney, David G. Miller, Scott Pendergast, Lawrence Singerman, Nicholas Zakov, Hernando Zegarra, Kim DuBois, Susan Rath, Lori Revella, Tammy Brink, Kim Drury, Lisa Hogue, Mary Ilc, Connie Keller, Elizabeth McNamara, Vivian Tanner, Tamara Cunningham, John DuBois, Gregg Greanoff, Trina Nitzsche, Sheila Smith-Brewer, Ricky D. Isernhagen, John W. Kitchens, Thomas W. Stone, William J. Wood, Diana Holcomb, Virginia Therrien, Michelle Buck, Jeanne Van Arsdall, Edward Slade, Todd E. Schneiderman, David J. Spinak, Jackie Gaedke, Heather Davis Brown, Dan Helgren, Jenifer Garrison Pangelinan, Lawrence Halperin, Scott Anagnoste, Mandeep Dhalla, Krista Rosenberg, Barry Taney, W. Scott Thompson, Jaclyn Lopez, Monica Hamlin, Monica Lopez, Jamie Mariano, Evelyn Quinchia, Patricia Aramayo, Rita Veksler, Michael Lee, Richard Dreyer, Irvin Handelman, Colin Ma, Mark Peters, Stephen Hobbs, Amanda Milliron, Marcia Kopfer, Michele Connaughton, A. Christine Hoerner, R. Joseph Logan, Harry J. Wohlsein, David Boyer, Thomas G. Chu, Pouya Dayani, David Liao, Roger L. Novack, Firas M. Rahhal, Richard Roe, Homayoun Tabandeh, Janet Bayramyan, Tammy Gasparyan, Connie Hoang, Janet Kurokouchi, Tammy Eileen Lo, Richard Ngo, Mary Ann Nguyen, Michael Peyton, Charles Yoon, Julio Sierra, Adam Zamboni, Jeff Kessinger, Eric Protacio, Adam Smucker, Pamela Rath, Robert Bergren, Bernard Doft, Judy Liu, Karl Olsen, Lori Merlotti, Willia Ingram, Kellianne Marfisi, Kimberly Yeckel, Heather Schultz Carmelo, Amanda Fec, Keith McBroom, David Steinberg, Marc Levy, Jody Abrams, Melvin Chen, Waldemar Torres, Peggy Jelemensky, Mark Prybylski, Tara Raphael, Diana Appleby, Charlotte Rodman, Mark Sneath, Robert H. Rosa, Vanessa Hoelscher, Adelia Castano, Jocelyn Parker, John Hoskins, Nicholas Anderson, Joseph Googe, Tod A. McMillan, James Miller, Stephen Perkins, Kristina Oliver, Jennifer Beerbower, Bruce Gilliland, Cecile Hunt, Mike Jacobus, Raul Lince, Christopher Morris, Sarah Oelrich, Jerry Whetstone, Clement K. Chan, Steven Lin, Kim Walther, Tiana Gonzales, Lenise Myers, Kenneth Huff, David M. Brown, Eric Chen, Matthew S. Benz, Richard H. Fish, Rosa Y. Kim, James Major, Tien Pei Wong, Charles Wycoff, Cassandra Cone, Debbie Goates Gilaspia, Nubia Landaverde, Robert Smith, Deneva Zamora, Veronica Sneed, Melina Vela, Eric Kegley, Craig Greven, Shree Kurup, Charles Richards, Madison Slusher, Cara Everhart, Joan Fish, Mark Clark, David Miller, Marshall Tyler, J. Michael Jumper, Arthur D. Fu, Robert N. Johnson, Brandon Lujan, H. Richard McDonald, Rosa Rodriguez, Nina Ansari, Jeanifer Joaquin, Silvia Linares, Lizette Lopez, Jessica Sabio, Sean Grout, Chad Indermill, Yesmin Urias, Roberto Zimmerman, Linda Margulies, Sara J. Schmidt, Joy L. Meier, Sherry L. Hadley, William Rosenthal, Barbara Johnson, Lois Swafford, Richard Shields, R. Scott Varner, Richard Rosen, Ronald Gentile, Melissa Rivas, Katy W. Tai, Wanda Carrasquillo-Boyd, Robert Masini, Glenn Stoller, Ken Carnevale, Diane M. LaRosa, Barbara Burger, Tereza Conway, Carla Del Castillo, Julissa Diaz, Susan Jones, Nina Mondoc, Charlene Balfour, C.H. Vitha, Jennifer Lutz, Barbara McGinley, Fadi El Baba, Ann Marie Lavorna, Renee Jones, Jean Lewis, Ruth Tenzler, Mary Salvas-Mladek, Diane Van Kesteren, W. Copley McLean, W. Zachery Bridges, Cameron Stone, Denise Ammons, Mary Lamy, Andrea Menzel, Lea Doll Raymer, Barbara Campbell, Lisa Hawkins, Leslie Rickman, Lorraine Sherlin, Paula Price, Albert Sinyai, Ronald Kingsley, Reagan H. Bradford, Robert E. Leonard, Sonny Icks, Vanessa Bergman, Brittany Ross, Russ Burris, Amanda Butt, Rob Richmond, Alice Lyon, Manjot Gill, Lee Jampol, Rukhsana Mizra, Zuzanna Rozenbajgier, Jeremy Chapman, Lori Kaminski, Andrea Degillio, Evica Simjanoski, Jeffrey Heier, Hyung Cho, Tina Scheufele Cleary, Darin Goldman, Chirag Shah, Trexler Topping, Marissa Weber, Torsten Wiegand, Jeremy Schindelheim, Joy Bankert, Jennifer Stone, Alison Nowak, Sandy Chong, Lindsay Williams, Steven Bennett, Dennis Donovan, Margaret Graham, Cullen Jones, Anne Fung, Jan-Kristine Bayabo, Razelda Bosch, Esperanza Cruz, Ashley Emerson, Alycia Fleming, Denice Barsness, Jorge Rodriguez, Marina Soboleva, Ingrid U. Scott, Esther Bowie, Kimberly A. Neely, David A. Quillen, Laura Walter, Timothy Bennett, James Strong, John Wells, Lloyd Clark, David Johnson, Peggy Miller, Mallie Taylor, Tiffany Swinford, Robbin Spivey, Michael Banach, Lawrence Ho, Richard Lanning, Thomas R. Pheasant, Jay G. Prensky, Steven Truong, Julia Teatsworth, Michelle Dietrich, Ann Wasilus, Ann Miller, Megan Rakes, Teresa Slagle, Michelle Richards, Patricia Schuessler, Lacy Stover, Paul Beer, Naomi S. Falk, Mary Beth Shannon, Jeannie Olmeda, Don Berdeen, Joseph F. Fisher, James Folk, Stephen Russell, Barbara Taylor, Connie Hinz, Jean Walshire, Heather Stockman, Bruce Critser, Stefani Karakas, Cindy Montague, Randy Verdick, Omesh Gupta, Joseph Maguire, Christopher Brady, Francis Char DeCroos, Michael Dollin, Sunir Garg, Adam Gerstenblith, Julia Haller, Allen C. Ho, Jason Hsu, Richard Kaiser, John Pitcher, Carl Regillo, Rajiv Shah, Marc Spirn, William Tasman, James Vander, Noga Senderowitsch, Michele Formoso, Michelle Markun, Cedric George, Christina Centinaro, Lisa Grande, Stefanie Carey, Elaine Liebenbaum, SriniVas Sadda, Mark Humayun, Rachel Sierra, Elizabeth Corona, Margaret Padilla, Moonseok Nu, Sylvia Ramos, Cullen Barnett, Glenn Currie, Cornelia Gottlieb, Richard Garfinkel, Daniel Berinstein, Marcus Colyer, William Deegan, Michael Min-Shyue Lai, Robert Murphy, Michael Osman, Michael Rivers, Reginald Sanders, Manfred A. von Fricken, Debbie Oliver, Jeanne Kirshon, Tanya Alexander Snowden, Thomas Blondo, Alysia Cronise, Vanessa Denny, Kylie Mendez, Janine Newgen, Justin Davis, Mike Flory, Robert Frantz, Bryan Murphy, Steve Rauch, Judy E. Kim, Jane Bachman, Thomas B. Connor, Dennis P. Han, Kimberly Stepian, David V. Weinberg, William J. Wirostko, Krissa Packard, Tracy Kaczanowski, Vesper Williams, Vicki Barwick, Judy Flanders, Dennis Backes, Joe Beringer, Kristy Keller, Kathy Selchert, Paul Bernstein, Michael Teske, Albert Vitale, Susan Allman, Bonnie Carlstrom, Kimberley Wegner, Anne Haroldsen, Deborah Harrison, Cyrie Fry, James Gilman, Glen Jenkins, Paula Morris, Michael Rauser, Joseph Fan, Mukesh Suthar, Gisela Santiago, Kara Rollins Halsey, Christy Quesada, William Kiernan, Jesse Knabb, Richard Alan Lewis, Cindy Dorenbach, Steven Spencer, Dana Barnett, Joseph Morales, Barron C. Fishburne, Jeffrey G. Gross, Michael A. Magee, Amy Flowers, Angie McDowell, Randall Price, Suber Huang, Johnny Tang, Shawn Wilker, Cherie Hornsby, Lisa Ferguson, Kirk Krogstad, Riva Adamovsky, Peggy Allchin, Kathleen Carlton, Claudia Clow, Kelly Sholtis, Stephanie Burke, Mark Harrod, Stacie Hrvatin, Geoffrey Pankhurst, Nelson R. Sabates, Michael Cassell, Komal Desai, Abraham Poulose, Felix Sabates, Yin Chen, Gary Gallimore, Yolanda Konior, Nicola Kim, Sami Uwaydat, Deborah Troillett, Karen Aletter, Robert N. Frank, Gary Abrams, James Puklin, Asheesh Tewari, Cheryl Milanovic, Melanie Bailey, David Griffith, Dena McDonald, Kit Morehead, Zlatan Sadikovic, Lisa Schillace, Elizabeth Silvis, Brian Joondeph, Nancy Christmas, Alan Kimura, Mimi Liu, Stephen Petty, John Zilis, Jenny Benitez, Cassandra Berryman Catlett, Eric Fluegel, Shane Mowry, Hoang Nguyen, David Reflow, Odette M. Houghton, Seema Garg, Maurice B. Landers, Travis Meredith, Sandy Barnhart, Megha Karmalkar, Debra Cantrell, Rona Lyn Esquejo-Leon, Linda Manor, Sue Pope, David Stines, Amelia Stokely, Dean Hainsworth, Dyann Helming, Debbie Eichelberger, Mary Paige Leaton, Chuck Hamm, Edward Chaum, Alessandro Iannaccone, Barbara Jennings, Tracy Murray, Joe Mastellone, Robert Millay, Brian Kim, Theresa Goddard, Liza Jarrett Beaudette, Nina Changelian-Aitken, Fernando Corrada, Jason Dubuque, Raymond Iezzi, Sophie J. Bakri, Jose S. Pulido, Diane Vogen, Rebecca Nielsen, Karin Berg, Jean Burrington, Shannon Howard, Joan Overend, Zbigniew Krason, Denise Lewison, Thomas Link, Kevin J. Blinder, Nicholas E. Engelbrecht, M. Gilbert Grand, Daniel P. Joseph, Gaurav K. Shah, Bradley Smith, Matthew Thomas, Rhonda Weeks, Lynda Boyd, Dana Gabel, Ron Adelman, John Huang, James Kempton, Aaron Parnes, Jennifer Dupont, Elizabeth Perotti, Victoria Donaldson, Kenneth Fong, Pamela Ossorio, Anita Agarwal, Paul Sternberg, Sandy Owings, Tony Adkins, Elaine Lok, Garvin Munn, Buddy Skellie, Neelakshi Bhagat, Monique S. Roy, Marco Zarbin, Catherine Fay, Michael Lazar, Beth Malpica, Tatiana Mikheyav, Lawrence Ulanski, Jennifer Lim, Marcia Niec, Tametha Johnson, Yesenia Ovando, Catherine Nail Carroll, Mark Janowicz, Steven Schwartz, David Cupp, Michael Gorin, Gad Heilweil, Hamid Hosseini, Jean-Pierre Hubschman, Allan Kreiger, Tara Young McCannel, Carolyn Pan, David Sarraf, Irena Tsui, Joshua Udoetek, Vinad Voleti, Logan Hitchcock, Rosaleen Ostrick, Melissa Chun, Jennie Kageyama, Nilo Davila, Kristin Lipka, Christina Shin, Cynthia Owsley, Michael Albert, Richard Feist, John Mason, Martin Thomley, Angelia Johnson, Tracy Emond, Joanna Hamela, Angela Marsh, Karen Searcey, Kia Rookard, Yu-Guang He, Rafael L. Ufret-Vincenty, Mike Molai, William Anderson, John Horna, Alan Letson, Colleen Cebulla, Susie Chang, Fred Davidorf, Jill Salerno, Laura Sladoje, Christina Stetson, Jeri Perry, Scott Savage, Cynthia Toth, Glenn Jaffe, Stefanie Schuman, Neeru Sarin, Jim Crowell, Tiffanie Keaton, Michael Kelly, Brian Lutman, Marriner Skelly, Lauren Welch, Lawrence Morse, Allan Hunter, Susanna Soon-Chun Park, Cynthia Wallace, Ember Dhillon, Marisa Salvador, Barbara Holderreed, Karishma Chandra, Sashi Kaur, Ellen Redenbo, Smiley Hom, Michael Cooney, Irene Barbazetto, James M. Klancnik, John A. Sorenson, Lawrence Yannuzzi, Maria Scolaro, Eugene Agresta, Nancy Gonzalez, Sandeep Grover, K.V. Chalam, Shailesh Gupta, Christopher Lyons, Wenhua Li, Chirag Patel, Jose Carrion, Henry Ferreyra, Amberly Rodriguez, Iliana Molina, Gabriel Balea, Pam Emory, Marlene Rico, Giorgio Siqueiros, Alexander J. Brucker, Joshua Dunaief, Juan Grunwald, Benjamin Kim, Albert M. Maguire, Brian VanderBeek, Sheri Drossner, Joan DuPont, Rebecca Salvo, Jim Berger, Cheryl Devine, Bill Nyberg, Laurel Weeney, David DiLoreto, Mina Chung, Valerie Davis, Peter MacDowell, George O. Gara, Daniel Castillo, Andrea Czubinski, Melissa Keim, Brandi Hardy, Rachel Grunhaus Hollar, Lynn Schueckler, Alice T. Lyon, Aaron Weinberg, Mira Shiloach, Nicole Pelkofer, Qin Zhou, Laura McPoland, Rajendra Apte, P. Kumar Rao, Sam Pistorius, Jamie Kambarian, Eve Adcock, Sarah Gould, Melanie Quinn, Rhonda Curtis, Amy Frost, Charla Meyer, and Greg Rathert

Subjects
0303 health sciences, medicine.medical_specialty, Visual acuity, genetic structures, business.industry, Eye disease, Hazard ratio, Age-Related Eye Disease Study, Retrospective cohort study, Fundus (eye), Macular degeneration, medicine.disease, eye diseases, 03 medical and health sciences, Ophthalmology, 0302 clinical medicine, 030221 ophthalmology & optometry, medicine, sense organs, medicine.symptom, Prospective cohort study, business, 030304 developmental biology
Abstract

Purpose To investigate the natural history and genetic associations of drusenoid pigment epithelial detachment (DPED) associated with age-related macular degeneration (AMD). Design Retrospective analysis of a prospective cohort study. Participants Of the 4203 Age-Related Eye Disease Study 2 (AREDS2) participants, 391 eyes (325 participants) had DPED without late AMD at the time of DPED detection. Genetic analyses included 120 white AREDS2 participants and 145 Age-Related Eye Disease Study (AREDS) participants with DPED. Methods Baseline and annual stereoscopic fundus photographs were graded centrally to detect DPED, a well-defined yellow elevated mound of confluent drusen ≥433 μm in diameter, and to evaluate progression rates to late AMD: geographic atrophy (GA) and neovascular (NV)-AMD. Five single nucleotide polymorphisms (CFH [rs10611670], C3 [rs2230199], CFI [rs10033900], C2/CFB [rs114254831], ARMS2 [rs10490924]) and genetic risk score (GRS) group were investigated for association with DPED development. Kaplan–Meier analyses and multivariable proportional hazard regressions were performed. Main Outcome Measures Progression rates to late AMD and decrease of ≥3 lines in visual acuity (VA) from the time of DPED detection; association of rate of DPED development with genotype. Results Mean (standard deviation [SD]) follow-up time from DPED detection was 4.7 (0.9) years. DPED was associated with increased risk of progression to late AMD (hazard ratio [HR], 2.36; 95% confidence interval [CI], 1.98–2.82; P Conclusions This study replicates the results of previous natural history studies of eyes with DPED including the high rates of progression to late AMD and vision loss (regardless of progression to late AMD). The genetic associations are consistent with genes associated with AMD progression.

Published
2019
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5. Progression of Geographic Atrophy in Age-related Macular Degeneration

Author

Tiarnan D. Keenan, Elvira Agrón, Amitha Domalpally, Traci E. Clemons, Freekje van Asten, Wai T. Wong, Ronald G. Danis, SriniVas Sadda, Philip J. Rosenfeld, Michael L. Klein, Rinki Ratnapriya, Anand Swaroop, Frederick L. Ferris, Emily Y. Chew, John Paul SanGiovanni, Traci Clemons, Anne Lindblad, Robert Lindblad, Nilay Shah, Robert Sperduto, Wendy McBee, Gary Gensler, Molly Harrington, Alice Henning, Katrina Jones, Kumar Thotapally, Diana Tull, Valerie Watson, Kayla Williams, Christina Gentry, Francine Kaufman, Chris Morrison, Elizabeth Saverino, Sherrie Schenning, Barbara Blodi, Ronald P. Danis, Matthew Davis, Kathy Glander, Gregory Guilfoil, Larry D. Hubbard, Kristine Johnson, Ronald Klein, Barbara Nardi, Michael Neider, Nancy Robinson, Eileen Rosensteel, Hugh Wabers, Grace Zhang, Alan J. Ruby, Antonio Capone, Bawa Dass, Kimberly Drenser, Bruce R. Garretson, Tarek S. Hassan, Michael Trese, George A. Williams, Jeremy Wolfe, Tina Bell, Mary Zajechowski, Dennis Bezaire, Fran McIver, Anthony Medina, Jackie Pagett, Stephanie Hatch Smith, Lynn Swartz, Tom Treuter, Andrew Antoszyk, Justin Brown, David J. Browning, Walter Holland, Angella Karow, Kelly Stalford, Angela Price, Sarah Ennis, Sherry Fredenberg, Jenna Herby, Uma Balasubramaniam, Loraine Clark, Donna McClain, Michael McOwen, Lynn Watson, Michael Klein, Steven T. Bailey, Thomas J. Hwang, Andreas Lauer, J. Timothy Stout, Patty McCollum, Milt Johnson, Patrick B. Rice, Ivana Kim, John Loewenstein, Joan Miller, Lucia Sobrin, Lucy Young, Jacqueline Sullivan, Patricia Houlihan, Linda Merry, Ann Marie Lane, Ursula Lord Bator, Claudia Evans, Sarah Brett, Charleen Callahan, Marcia Grillo, David Walsh, Kamella Lau Zimmerman, Gary Edd Fish, Rajiv Anand, Lori E. Coors, Dwain G. Fuller, Rand Spencer, Robert C. 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Bressler, Daniel Finkelstein, Steven H. Sherman, Sharon Solomon, Howard S. Ying, Rita Denbow, Deborah Phillips, Elizabeth Radcliffe, Judy Belt, Dennis Cain, David Emmert, Mark Herring, Jacquelyn McDonald, G. Baker Hubbard, Chris S. Bergstrom, Blaine Cribbs, Andrew Hendrick, Brandon Johnson, Philip Laird, Sonia Mehta, Timothy Olsen, Justin Townsend, Jion Yan, Steven Yeh, Linda Curtis, Judy Brower, Hannah Yi, Jannah Rutter Dobbs, Debbie Jordan, Michael J. Elman, Robert A. Liss, JoAnn Starr, Jennifer Belz, Charlene Putzulo, Teresa Coffey, Ashley Davis, Pamela Singletary, Giorya Shabi Andreani, Theresa Cain, Daniel Ketner, Peter Sotirakos, Suresh Chandra, Barbara A. Blodi, Michael M. Altaweel, Justin L. Gottlieb, Michael Ip, T. Michael Nork, Thomas S. Stevens, Kathryn Burke, Shelly Olson, Kristine Dietzman, Barbara Soderling, Guy Somers, Angie Wealti, Denise Krolnik, John Peterson, Sandra Reed, Thomas Friberg, Andrew Eller, Denise Gallagher, Leanne Labriola, Melissa Pokrifka, Aron Gedansky, Natalie Anthony, Cassandra Grzybowski, Dawn Matthews, Sharon Murajda-Jumba, Jessica Toro, David G. Callanan, Wayne A. Solley, Patrick Williams, Sandy Lash, Bob Boleman, Chris Dock, Michel Shami, Brenda Arrington, Ashaki Meeks, Alan R. Margherio, Paul Raphaelian, Debra Markus, Justin Langdon, Elizabeth Truax, Sandy Lewis, Brad Terry, Amy Noffke, Kean Oh, Ramin Sarrafizadeh, Scott Sneed, Julie Hammersley, Serena Neal, Mary Doran, Nan Jones, Lisa Preston, Heather Jessick, Tanya Tracy Marsh, Michael Tolentino, Adam Berger, Richard Hamilton, David Misch, Suk Jin Moon, Dawn Sutherland, Vera Dilts, Sara Henderson, Esmeralda Medina, Donald Trueman, Laura Holm, Jason Strickland, Darmakusuma Ie, Jeffrey L. Lipkowitz, Kekul B. Shah, Susan Geraghty, Beverly Sannazzaro, Morgan Harper, Krista Bayer, Mary B. Lansing, Lauren B. Fox, Rebecca Lee, Jay B. Stallman, Michael Jacobson, Sean Koh, Scott Lampert, John Miller, Mark Rivellese, Atul Sharma, Robert A. Stoltz, Stephanie Vanderveldt, Leslie Marcus, Starr Hendricks, Ryan Hollman, Grethel Betanzos, Leslie Ellorin, Shelly Fulbright, Debbie McCormick, Paul A. Edwards, Julianne Hall, Mary Monk, Melanie Gutkowski, Melina Mazurek, Janet Murphy, Katherine Gusas, Crystal Moffett, David Burley, Nicole Chesney, Katie Kilgo, Brian Rusinek, Bradley Stern, Tracy Troszak, Rhonda Baker-Levingston, Carl W. Baker, Tracey Caldwell, Tammy Walker, Lynnette F. Lambert, Tracey Martin, Mary Jill Palmer, Tana Williams, Michael A. Novak, Joseph Coney, David G. Miller, Scott Pendergast, Lawrence Singerman, Nicholas Zakov, Hernando Zegarra, Kim DuBois, Susan Rath, Lori Revella, Tammy Brink, Kim Drury, Lisa Hogue, Mary Ilc, Connie Keller, Elizabeth McNamara, Vivian Tanner, Tamara Cunningham, John DuBois, Gregg Greanoff, Trina Nitzsche, Sheila Smith-Brewer, Ricky D. Isernhagen, John W. Kitchens, Thomas W. Stone, William J. Wood, Diana Holcomb, Virginia Therrien, Michelle Buck, Jeanne Van Arsdall, Edward Slade, Todd E. Schneiderman, David J. Spinak, Jackie Gaedke, Heather Davis Brown, Dan Helgren, Jenifer Garrison Pangelinan, Lawrence Halperin, Scott Anagnoste, Mandeep Dhalla, Krista Rosenberg, Barry Taney, W. Scott Thompson, Jaclyn Lopez, Monica Hamlin, Monica Lopez, Jamie Mariano, Evelyn Quinchia, Patricia Aramayo, Rita Veksler, Michael Lee, Richard Dreyer, Irvin Handelman, Colin Ma, Mark Peters, Stephen Hobbs, Amanda Milliron, Marcia Kopfer, Michele Connaughton, A. Christine Hoerner, R. Joseph Logan, Harry J. Wohlsein, David Boyer, Thomas G. Chu, Pouya Dayani, David Liao, Roger L. Novack, Firas M. Rahhal, Richard Roe, Homayoun Tabandeh, Janet Bayramyan, Tammy Gasparyan, Connie Hoang, Janet Kurokouchi, Tammy Eileen Lo, Richard Ngo, Mary Ann Nguyen, Michael Peyton, Charles Yoon, Julio Sierra, Adam Zamboni, Jeff Kessinger, Eric Protacio, Adam Smucker, Pamela Rath, Robert Bergren, Bernard Doft, Judy Liu, Karl Olsen, Lori Merlotti, Willia Ingram, Kellianne Marfisi, Kimberly Yeckel, Heather Schultz Carmelo, Amanda Fec, Keith McBroom, David Steinberg, Marc Levy, Jody Abrams, Melvin Chen, Waldemar Torres, Peggy Jelemensky, Mark Prybylski, Tara Raphael, Diana Appleby, Charlotte Rodman, Mark Sneath, Robert H. Rosa, Vanessa Hoelscher, Adelia Castano, Jocelyn Parker, John Hoskins, Nicholas Anderson, Joseph Googe, Tod A. McMillan, James Miller, Stephen Perkins, Kristina Oliver, Jennifer Beerbower, Bruce Gilliland, Cecile Hunt, Mike Jacobus, Raul Lince, Christopher Morris, Sarah Oelrich, Jerry Whetstone, Clement K. Chan, Steven Lin, Kim Walther, Tiana Gonzales, Lenise Myers, Kenneth Huff, David M. Brown, Eric Chen, Matthew S. Benz, Richard H. Fish, Rosa Y. Kim, James Major, Tien Pei Wong, Charles Wycoff, Cassandra Cone, Debbie Goates Gilaspia, Nubia Landaverde, Robert Smith, Deneva Zamora, Veronica Sneed, Melina Vela, Eric Kegley, Craig Greven, Shree Kurup, Charles Richards, Madison Slusher, Cara Everhart, Joan Fish, Mark Clark, David Miller, Marshall Tyler, J. Michael Jumper, Arthur D. Fu, Robert N. Johnson, Brandon Lujan, H. Richard McDonald, Rosa Rodriguez, Nina Ansari, Jeanifer Joaquin, Silvia Linares, Lizette Lopez, Jessica Sabio, Sean Grout, Chad Indermill, Yesmin Urias, Roberto Zimmerman, Linda Margulies, Sara J. Schmidt, Joy L. Meier, Sherry L. Hadley, William Rosenthal, Barbara Johnson, Lois Swafford, Richard Shields, R. Scott Varner, Richard Rosen, Ronald Gentile, Melissa Rivas, Katy W. Tai, Wanda Carrasquillo-Boyd, Robert Masini, Glenn Stoller, Ken Carnevale, Diane M. LaRosa, Barbara Burger, Tereza Conway, Carla Del Castillo, Julissa Diaz, Susan Jones, Nina Mondoc, Charlene Balfour, C.H. Vitha, Jennifer Lutz, Barbara McGinley, Fadi El Baba, Ann Marie Lavorna, Renee Jones, Jean Lewis, Ruth Tenzler, Mary Salvas-Mladek, Diane Van Kesteren, W. Copley McLean, W. Zachery Bridges, Cameron Stone, Denise Ammons, Mary Lamy, Andrea Menzel, Lea Doll Raymer, Barbara Campbell, Lisa Hawkins, Leslie Rickman, Lorraine Sherlin, Paula Price, Albert Sinyai, Ronald Kingsley, Reagan H. Bradford, Robert E. Leonard, Sonny Icks, Vanessa Bergman, Brittany Ross, Russ Burris, Amanda Butt, Rob Richmond, Alice Lyon, Manjot Gill, Lee Jampol, Rukhsana Mizra, Zuzanna Rozenbajgier, Jeremy Chapman, Lori Kaminski, Andrea Degillio, Evica Simjanoski, Jeffrey Heier, Hyung Cho, Tina Scheufele Cleary, Darin Goldman, Chirag Shah, Trexler Topping, Marissa Weber, Torsten Wiegand, Jeremy Schindelheim, Joy Bankert, Jennifer Stone, Alison Nowak, Sandy Chong, Lindsay Williams, Steven Bennett, Dennis Donovan, Margaret Graham, Cullen Jones, Anne Fung, Jan-Kristine Bayabo, Razelda Bosch, Esperanza Cruz, Ashley Emerson, Alycia Fleming, Denice Barsness, Jorge Rodriguez, Marina Soboleva, Ingrid U. Scott, Esther Bowie, Kimberly A. Neely, David A. Quillen, Laura Walter, Timothy Bennett, James Strong, John Wells, Lloyd Clark, David Johnson, Peggy Miller, Mallie Taylor, Tiffany Swinford, Robbin Spivey, Michael Banach, Lawrence Ho, Richard Lanning, Thomas R. Pheasant, Jay G. Prensky, Steven Truong, Julia Teatsworth, Michelle Dietrich, Ann Wasilus, Ann Miller, Megan Rakes, Teresa Slagle, Michelle Richards, Patricia Schuessler, Lacy Stover, Paul Beer, Naomi S. Falk, Mary Beth Shannon, Jeannie Olmeda, Don Berdeen, Joseph F. Fisher, James Folk, Stephen Russell, Barbara Taylor, Connie Hinz, Jean Walshire, Heather Stockman, Bruce Critser, Stefani Karakas, Cindy Montague, Randy Verdick, Omesh Gupta, Joseph Maguire, Christopher Brady, Francis Char DeCroos, Michael Dollin, Sunir Garg, Adam Gerstenblith, Julia Haller, Allen C. Ho, Jason Hsu, Richard Kaiser, John Pitcher, Carl Regillo, Rajiv Shah, Marc Spirn, William Tasman, James Vander, Noga Senderowitsch, Michele Formoso, Michelle Markun, Cedric George, Christina Centinaro, Lisa Grande, Stefanie Carey, Elaine Liebenbaum, Mark Humayun, Rachel Sierra, Elizabeth Corona, Margaret Padilla, Moonseok Nu, Sylvia Ramos, Cullen Barnett, Glenn Currie, Cornelia Gottlieb, Richard Garfinkel, Daniel Berinstein, Marcus Colyer, William Deegan, Michael Min-Shyue Lai, Robert Murphy, Michael Osman, Michael Rivers, Reginald Sanders, Manfred A. von Fricken, Debbie Oliver, Jeanne Kirshon, Tanya Alexander Snowden, Thomas Blondo, Alysia Cronise, Vanessa Denny, Kylie Mendez, Janine Newgen, Justin Davis, Mike Flory, Robert Frantz, Bryan Murphy, Steve Rauch, Judy E. Kim, Jane Bachman, Thomas B. Connor, Dennis P. Han, Kimberly Stepian, David V. Weinberg, William J. Wirostko, Krissa Packard, Tracy Kaczanowski, Vesper Williams, Vicki Barwick, Judy Flanders, Dennis Backes, Joe Beringer, Kristy Keller, Kathy Selchert, Paul Bernstein, Michael Teske, Albert Vitale, Susan Allman, Bonnie Carlstrom, Kimberley Wegner, Anne Haroldsen, Deborah Harrison, Cyrie Fry, James Gilman, Glen Jenkins, Paula Morris, Michael Rauser, Joseph Fan, Mukesh Suthar, Gisela Santiago, Kara Rollins Halsey, Christy Quesada, William Kiernan, Jesse Knabb, Richard Alan Lewis, Cindy Dorenbach, Steven Spencer, Dana Barnett, Joseph Morales, Barron C. Fishburne, Jeffrey G. Gross, Michael A. Magee, Amy Flowers, Angie McDowell, Randall Price, Suber Huang, Johnny Tang, Shawn Wilker, Cherie Hornsby, Lisa Ferguson, Kirk Krogstad, Riva Adamovsky, Peggy Allchin, Kathleen Carlton, Claudia Clow, Kelly Sholtis, Stephanie Burke, Mark Harrod, Stacie Hrvatin, Geoffrey Pankhurst, Nelson R. Sabates, Michael Cassell, Komal Desai, Abraham Poulose, Felix Sabates, Yin Chen, Gary Gallimore, Yolanda Konior, Nicola Kim, Sami Uwaydat, Deborah Troillett, Karen Aletter, Robert N. Frank, Gary Abrams, James Puklin, Asheesh Tewari, Cheryl Milanovic, Melanie Bailey, David Griffith, Dena McDonald, Kit Morehead, Zlatan Sadikovic, Lisa Schillace, Elizabeth Silvis, Brian Joondeph, Nancy Christmas, Alan Kimura, Mimi Liu, Stephen Petty, John Zilis, Jenny Benitez, Cassandra Berryman Catlett, Eric Fluegel, Shane Mowry, Hoang Nguyen, David Reflow, Odette M. Houghton, Seema Garg, Maurice B. Landers, Travis Meredith, Sandy Barnhart, Megha Karmalkar, Debra Cantrell, Rona Lyn Esquejo-Leon, Linda Manor, Sue Pope, David Stines, Amelia Stokely, Dean Hainsworth, Dyann Helming, Debbie Eichelberger, Mary Paige Leaton, Chuck Hamm, Edward Chaum, Alessandro Iannaccone, Barbara Jennings, Tracy Murray, Joe Mastellone, Robert Millay, Brian Kim, Theresa Goddard, Liza Jarrett Beaudette, Nina Changelian-Aitken, Fernando Corrada, Jason Dubuque, Raymond Iezzi, Sophie J. Bakri, Jose S. Pulido, Diane Vogen, Rebecca Nielsen, Karin Berg, Jean Burrington, Shannon Howard, Joan Overend, Zbigniew Krason, Denise Lewison, Thomas Link, Kevin J. Blinder, Nicholas E. Engelbrecht, M. Gilbert Grand, Daniel P. Joseph, Gaurav K. Shah, Bradley Smith, Matthew Thomas, Rhonda Weeks, Lynda Boyd, Dana Gabel, Ron Adelman, John Huang, James Kempton, Aaron Parnes, Jennifer Dupont, Elizabeth Perotti, Victoria Donaldson, Kenneth Fong, Pamela Ossorio, Anita Agarwal, Paul Sternberg, Sandy Owings, Tony Adkins, Elaine Lok, Garvin Munn, Buddy Skellie, Neelakshi Bhagat, Monique S. Roy, Marco Zarbin, Catherine Fay, Michael Lazar, Beth Malpica, Tatiana Mikheyav, Lawrence Ulanski, Jennifer Lim, Marcia Niec, Tametha Johnson, Yesenia Ovando, Catherine Nail Carroll, Mark Janowicz, Steven Schwartz, David Cupp, Michael Gorin, Gad Heilweil, Hamid Hosseini, Jean-Pierre Hubschman, Allan Kreiger, Tara Young McCannel, Carolyn Pan, David Sarraf, Irena Tsui, Joshua Udoetek, Vinad Voleti, Logan Hitchcock, Rosaleen Ostrick, Melissa Chun, Jennie Kageyama, Nilo Davila, Kristin Lipka, Christina Shin, Cynthia Owsley, Michael Albert, Richard Feist, John Mason, Martin Thomley, Angelia Johnson, Tracy Emond, Joanna Hamela, Angela Marsh, Karen Searcey, Kia Rookard, Yu-Guang He, Rafael L. Ufret-Vincenty, Mike Molai, William Anderson, John Horna, Alan Letson, Colleen Cebulla, Susie Chang, Fred Davidorf, Jill Salerno, Laura Sladoje, Christina Stetson, Jeri Perry, Scott Savage, Cynthia Toth, Glenn Jaffe, Stefanie Schuman, Neeru Sarin, Jim Crowell, Tiffanie Keaton, Michael Kelly, Brian Lutman, Marriner Skelly, Lauren Welch, Lawrence Morse, Allan Hunter, Susanna Soon-Chun Park, Cynthia Wallace, Ember Dhillon, Marisa Salvador, Barbara Holderreed, Karishma Chandra, Sashi Kaur, Ellen Redenbo, Smiley Hom, Michael Cooney, Irene Barbazetto, James M. Klancnik, John A. Sorenson, Lawrence Yannuzzi, Maria Scolaro, Eugene Agresta, Nancy Gonzalez, Sandeep Grover, K.V. Chalam, Shailesh Gupta, Christopher Lyons, Wenhua Li, Chirag Patel, Jose Carrion, Henry Ferreyra, Amberly Rodriguez, Iliana Molina, Gabriel Balea, Pam Emory, Marlene Rico, Giorgio Siqueiros, Alexander J. Brucker, Joshua Dunaief, Juan Grunwald, Benjamin Kim, Albert M. Maguire, Brian VanderBeek, Sheri Drossner, Joan DuPont, Rebecca Salvo, Jim Berger, Cheryl Devine, Bill Nyberg, Laurel Weeney, David DiLoreto, Mina Chung, Valerie Davis, Peter MacDowell, George O. Gara, Daniel Castillo, Andrea Czubinski, Melissa Keim, Brandi Hardy, Rachel Grunhaus Hollar, Lynn Schueckler, Alice T. Lyon, Aaron Weinberg, Mira Shiloach, Nicole Pelkofer, Qin Zhou, Laura McPoland, Rajendra Apte, P. Kumar Rao, Sam Pistorius, Jamie Kambarian, Eve Adcock, Sarah Gould, Melanie Quinn, Rhonda Curtis, Amy Frost, Charla Meyer, and Greg Rathert

Subjects
0301 basic medicine, medicine.medical_specialty, genetic structures, business.industry, Eye disease, Incidence (epidemiology), Fundus (eye), Macular degeneration, medicine.disease, eye diseases, Confidence interval, Geographic atrophy, 03 medical and health sciences, Ophthalmology, 030104 developmental biology, 0302 clinical medicine, Age related, 030221 ophthalmology & optometry, medicine, sense organs, Prospective cohort study, business
Abstract

Purpose To analyze the prevalence, incidence, and clinical characteristics of eyes with geographic atrophy (GA) in age-related macular degeneration (AMD), including clinical and genetic factors affecting enlargement. Design Prospective cohort study within a controlled clinical trial. Participants Age-Related Eye Disease Study 2 (AREDS2) participants, aged 50–85 years. Methods Baseline and annual stereoscopic color fundus photographs were evaluated for GA presence and area. Analyses included GA prevalence and incidence rates, Kaplan-Meier rates, mixed-model regression, and multivariable analysis of the square root of GA, area adjusted for covariates, including clinical/imaging characteristics and genotype. Main Outcome Measures (1) Presence or development of GA; (2) change in the square root of GA area over time. Results At baseline, 517 eyes (6.2%) of 411 participants (9.8%) had pre-existing GA (without neovascular AMD), with the following characteristics: 33% central, 67% noncentral; and the following configurations: 36% small, 26% solid/unifocal, 24% multifocal, 9% horseshoe/ring, and 6% indeterminate. Of the remaining 6530 eyes at risk, 1099 eyes (17.3%) of 883 participants developed incident GA without prior neovascular disease during mean follow-up of 4.4 years. The Kaplan-Meier rate of incident GA was 19% of eyes at 5 years. In eyes with incident GA, 4-year risk of subsequent neovascular AMD was 29%. In eyes with incident noncentral GA, 4-year risk of central involvement was 57%. GA enlargement rate (following square root transformation) was similar in eyes with pre-existing GA (0.29 mm/year; 95% confidence interval 0.27–0.30) and incident GA (0.28 mm/year; 0.27–0.30). In the combined group, GA enlargement was significantly faster with noncentrality, multifocality, intermediate baseline size, and bilateral GA (P Conclusions Analyses of AREDS2 data on natural history of GA provide representative data on GA evolution and enlargement. GA enlargement, which was influenced by lesion features, was relentless, resulting in rapid central vision loss. The genetic variants associated with faster enlargement were partially distinct from those associated with risk of incident GA. These findings are relevant to further investigations of GA pathogenesis and clinical trial planning.

Published
2018
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6. Plasma Vascular Endothelial Growth Factor Concentrations after Intravitreous Anti–Vascular Endothelial Growth Factor Therapy for Diabetic Macular Edema

Author

Lee M. Jampol, Adam R. Glassman, Danni Liu, Lloyd Paul Aiello, Neil M. Bressler, Elia J. Duh, Susan Quaggin, John A. Wells, Charles C. Wykoff, David Browning, Andrew N. Antoszyk, Angela K. Price, Sherry L. Fredenberg, Jenna T. Herby, Christina J. Fleming, Ashley A. McClain, Sarah A. Ennis, Kelly R. Gallagher, Angella S. Karow, Autumn C. Grupp, Danielle Puskas, Lynn Watson, Swann J. Bojaj, Uma M. Balasubramaniam, Donna McClain, Donna R. Styles, Jeff A. Kuopus, Kathryn Kimrey, Loraine M. Clark, Lisa A. Jackson, Michael D. McOwen, Matt Dunlap, Susannah J. Held, Dante J. Pieramici, Ma'an A. Nasir, Alessandro A. Castellarin, Dilsher Dhoot, Sarah Fishbein, Jack Giust, Lisha Wan, Michelle S. Hanna, Melvin D. Rabena, Jerry Smith, Layne J. Bone, Kelly Avery, Matthew Giust, Aimee Walker, Aimee H. Shook, Sara Esau, Nitce L. Ruvalcaba, W. Lloyd Clark, David L. Johnson, John F. Payne, Tiffany R. Swinford, Mallie M. Taylor, Cassandra L. Garrison, Peggy D. Miller, Amber R. Houlahan, Charlotte A. O'Neill, Ashley Floyd, Crystal C. Parker, Courtney Sease, Tara Graham, Robin Spencer, Tiffany N. Ogbuewu, Ashley Studebaker, Tyler Huggins, Robbin Spivey, Brian Jones, Ashley Williams, Ron Petty, Erin L. Poston, G. Michael Ward, Carl W. Baker, Ron H. Tilford, Tracey M. Caldwell, Lynnette F. Lambert, Mary J. Palmer, Tracey R. Martin, Tana R. Williams, Samantha Kettler, Alecia B. Camp, Paolo S. Silva, Paul G. Arrigg, George S. Sharuk, Sabera T. Shah, Jennifer K. Sun, Corey Westerfeld, Christopher Michael Andreoli, Deborah Schlossman, Timothy Murtha, Hanna Kwak, Flor M. Flores, Margaret E. Stockman, Troy Kieser, Michael N. Krigman, Leila Bestourous, Elizabeth S. Weimann, Jerry D. Cavallerano, Kristen M. Hock, Mary Ann Robertson, Rita K. Kirby, Steve L. Papaconstantinou, Kylie M. Madigan, Robert W. Cavicchi, Kate A. Palitsch, Taygan Yilmaz, Brian B. Berger, Chirag D. Jhaveri, Tori Moore, Ginger J. Manhart, Rachel A. Walsh, Ivana Gunderson, Dietrich Riepen, Chelsey A. Bravenec, Ryan M. Reid, Yong Ren, Ben Ostrander, Christopher C. Stovall, Michael J. Elman, Robert A. Liss, Henry A. Leder, JoAnn Starr, Jennifer L. Belz, Charlene K. Putzulo, Dallas R. Sandler, Jennifer L. Simmons, Pamela V. Singletary, Ashley Davis, Perel M. Simpson, Teresa Coffey, Daniel J. Ketner, Terri Cain, Ashley M. Metzger, Peter Sotirakos, Dennis M. Marcus, Harinderjit Singh, Courtney N. Roberts, Geri L. Floyd, Siobhan O. Ortiz, Virginia Mims, L. Allison Foster, Christy Coursey, Jared C. Gardner, Ken Ivey, John Stewart O'Keefe, Juan A. Astruc, Bryan J. Schwent, Ali R. Tabassian, Suzette A. Rosen, David C. Vaughan, Jeffrey Michaels, Natalie J. Arndt, John J. Maziarz, Scott M. Friedman, Nader Moinfar, Kimberly A. Williamson, Damanda F. Fagan, Katrina L. Dawson, Paige N. Walters, Allen McKinney, Steve Carlton, Robert C. Kwun, Victoria L. Knudsen, Kirk E. Winward, Mano Swartz, James G. Howard, Michelle Riley, Gena Taylor, Michelle Holt, Jason G. Winward, Adam Walsh, Teresa Taylor, Daniel Walsh, G. Robert Hampton, Jamin S. Brown, Rajeev K. Seth, Laurie J. Sienkiewycz, Deborah A. Appleton, Cindy J. Grinnell, Charity A. Cowley, Lynn M. Kwasniewski, Michelle L. Manley, Nicole E. Robarge, Stefanie R. DeSantis, Peter B. Hay, Teresa M. DeForge, Tien P. Wong, Eric Chen, David M. Brown, Rosa Y. Kim, James C. Major, Amy C. Schefler, Richard H. Fish, Matthew S. Benz, Meredith Lipman, Amy Hutson, Nubia Landaverde, Ashley E. Chancey, Cassie Cone, Tressa Royse, Veronica A. Sneed, Belinda A. Almanza, Brenda Dives, Beau A. Richter, Eric N. Kegley, Andreas K. Lauer, Christina J. Flaxel, Steven T. Bailey, Mitchell Schain, Ann D. Lundquist, Shelley A. Hanel, Shirley D. Ira, Susan K. Nolte, Peter N. Steinkamp, Dawn M. Ryan, Scott R. Pickell, Jocelyn T. Hui, Michelle Brix, Jordan Barth, Chris S. Howell, Gregory M. Fox, Blake A. Cooper, Ivan R. Batlle, Lexie R. Manning, Karla A. Batlle, Holly Wyrick, Katherine Pippin, Samantha Perkins, Frank T. Yeager, Ryan B. Rush, Glenn R. Gardner, Christi Rush, Johnathan R. Hawkins, Brenda Dumas, Ben Ysasaga, Chirag P. Shah, Michael G. Morley, Torsten W. Wiegand, Tina S. Cleary, Trexler M. Topping, Lindsey Colegrove, Katharine Bechtel, Britta Johnson, Lisa Lebedew, Natacha Lorius, Sandy G. Chong, Jennifer L. Stone, Michael Cullen Jones, Dennis Donovan, Sherry Malone, Margie Graham, Audrey Santos, Steve A. Bennett, Kevin J. Blinder, Bradley T. Smith, Ginny S. Nobel, Rhonda F. Weeks, Erika A. Hoehn, Maria A. Stuart, Kelly E. Pepple, Lynda K. Boyd, Brook G. Pulliam, Steve A. Schremp, Stephanie L. Guevara, Jarrod Wehmeier, Timothy L. Wright, Dana L. Gabel, David G. Miller, Jerome P. Schartman, Lawrence J. Singerman, Joseph M. Coney, Michael A. Novak, Llewelyn J. Rao, Susan C. Rath, Elizabeth McNamara, Larraine Stone, Veronica A. Smith, Cecelia Rykena, Kimberly A. DuBois, Mary A. Ilc, Vivian Tanner, Kim Drury, Trina M. Nitzsche, Gregg A. Greanoff, John C. DuBois, Stuart K. Burgess, Tirso M. Lara, Noel H. Pereda, Cindy V. Fernandez, Deborah Davis, Evelyn Quinchia, Karen Workman, Jared S. Nielsen, Jeong-Hyeon Sohn, Kyle J. Alliman, David D. Saggau, Marianne Parker, Bethany George, Carrie L. Eastvold, Kristin Sells, Tami Jo Woehl, Marilyn A. Johnson, Holly Keenan, Jennifer L. Coleman, Jamie Spillman, Shannon Freeman, Leigh S. Schmidt, Lisa M. Boender, Jill L. Partin, Bailey R. Bennett, Jay Rostvold, Cameron McLure Stone, Lea R. Raymer, Andrea K. Menzel, Leslie D. Rickman, Barbara Campbell, Lorraine P. Sherlin, Lisa H. Hawkins, Melissa L. Buckner, Olesya N. Matsipura, Paula A. Price, A. Thomas Ghuman, Paul A. Raskauskas, Ashish G. Sharma, Glenn Wing, Joseph P. Walker, Eileen Knips, Cheryl Kiesel, Crystal Y. Peters, Cheryl Ryan, Laura Greenhoe, Natalie N. Torres, Rebecca J. Youngblood, Danielle Turnbo, Anita H. Leslie, Etienne C. Schoeman, Raymond K. Kiesel, Ronald M. Kingsley, Vinay A. Shah, Robert E. Leonard, Heather R. Miller, Sonny Icks, Vanessa A. Bergman, Vanessa K. Drummond, Brittany L. Ross, Reshial D. Ellis, Tina R. Whittington, Shannon R. Almeida, Amanda M. Butt, Russ Burris, Mark A. Peters, Michael S. Lee, Paul S. Tlucek, Colin Ma, Stephen Hobbs, Amanda C. Milliron, Stephanie L. Ho, Marcia Kopfer, Joe Logan, Christine Hoerner, Joseph A. Khawly, Hassan T. Rahman, Diana Abdelgani, Pam S. Miller, Debbie Fredrickson, Erica Pineda, Desiree Lopez, Donald K. Lowd, Colin Blank, Lorena R. Martinez, Jason E. Muniz, Justin Gottlieb, Michael S. Ip, Barbara A. Blodi, Kristine A. Dietzman, Kathryn F. Burke, Christopher M. Smith, Shelly R. Olson, Angela M. Wealti, Sandie L. Reed, Denise A. Krolnik, John C. Peterson, Victor Hugo Gonzalez, Roberto Diaz-Rohena, Juan G. Santiago, Rohit Adyanthaya, Nehal R. Patel, Deyla Anaya, Dina Garcia, Edna E. Cruz, Crystal A. Alvarez, Ruth Iracheta, Jessica Rodriguez, Monica R. Cantu, Rebecca R. Flores, Hector Jasso, Rachel Rodriguez, Karina Miranda, Krystle R. Lozano, Maricela Garza, Lazaro Aguero, Amanda L. Sandoval, Monique Montemayor, Samuel Alonso, Santos Garza, David Allen DiLoreto, Rajeev S. Ramchandran, David M. Kleinman, George W. O'Gara, Andrea M. Czubinski, Peter MacDowell, Kari M. Steinmetz, Dan A. Castillo, Yvonne F. Yu, Salina M. Tongue, Melissa S. Keim, Rachel Hollar, Brandi N. Deats, Brittany S. Richardson, Lynn Singer, Taylor A. Pannell, Stewart A. Daniels, Tushar M. Ranchod, Craig J. Leong, Stacey Touson, Shannon R. Earl, Melissa C. Bartlett, Christine Fernando, Djorella Factor, Jessica Garcia, Anna K. Nguyen, Betty Hom, Cathy Walker, Grace M. Marudo, Jose Carlos Suazo, Leah M. McNeil, Fred Hanamoto, Matthew D. Hughes, Robin D. Ross, Susan M. Sanford, Nicole Martini Markiewicz, Tracy M. Utley, Shannon Henderson, Joanie H. Lippincott, Patricia Streasick, Louis C. Glazer, Frank W. Garber, Jeffrey D. Zheutlin, Angela D. Listerman, Christine E. Feehan, Heather L. Cruz, Donald E. Kuitula, Olivia P. Rainey, Sue Weatherbee, Joseph M. Googe, R. Keith Shuler, Nicholas G. Anderson, Stephen L. Perkins, Kristina Oliver, Nicole Grindall, Ann Arnold, Jennifer Beerbower, Cecile Hunt, Kathy L. Schulz, Sarah M. Oelrich, Jerry K. Whetstone, Justin Walsh, Chris Morris, Robert W. Wong, Peter A. Nixon, Jeni L. Leon, Chris A. Montesclaros, Carrie E. Leung, Phill Le, Codey L. Harborth, Margaret A. Rodriguez, Cory Mangham, Thomas M. Aaberg, Scott J. Westhouse, Holly L. Vincent, Rebecca Malone, Kathy L. Karsten, Raj K. Maturi, Ashley M. Harless, Carolee K. Novak, Laura A. Bleau, Thomas Steele, Charlotte Harris, Alisha Bildner, Abby Maple, Thomas W. Stone, Rick D. Isernhagen, John W. Kitchens, Diana M. Holcomb, Jeanne Van Arsdall, Michelle Buck, Edward A. Slade, Mark T. Chiu, Ashok K. Reddy, Frank W. Wyant, Mary M. Montano-Niles, Lorraine J. Carter, Shirley Maerki, Laura Tartaglia, Paul P. Gomez, Stephen A. Maestas, Camille Shanta, Lisbrenda M. Jimenez, Robert A. Stoltz, Stephanie L. Vanderveldt, Scott I. Lampert, Leslie G. Marcus, Shelly Fulbright, James P. Martin, Roger L. Novack, David S. Liao, Tammy Eileen Lo, Janet Kurokouchi, Richard Ngo, Connie V. Hoang, Julio Sierra, Adam Zamboni, Eric G. Protacio, Jeff Kessinger, Seema Garg, Odette M. Houghton, Jan Niklas Ulrich, Sai H. Chavala, Elizabeth L. DuBose, Cassandra J. Barnhart, Megha Karmalkar, Pooja D. Jani, Justin Goble, Debra Cantrell, Rona Lyn Esquejo, Sandeep N. Shah, Natasha Harmon, Mandeep S. Dhalla, Mario R. del Cid, Lawrence S. Halperin, Jaclyn A. Brady, Monica Hamlin, Monica L. Lopez, Jamie Mariano, Candace M. Neale, Rita R. Veksler, Angelica Mannarelli, Robert E. Coffee, Petros Euthymiou Carvounis, Pejman Hemati, Cindy J. Dorenbach, Annika S. Joshi, April Leger, Dana B. Barnett, Joseph F. Morales, Sam E. Mansour, Cathy Choyce, Aissa L. Dirawatun, Emma A. Nagy, Jamie C. Kerkstra, Joseph T. Fan, Mukesh Bhogilal Suthar, Michael E. Rauser, Gisela Santiago, Liel Marvyn Cerdenio, Brandi J. Perez, Kara E. Halsey, William H. Kiernan, Jesse Knabb, Rachel Catren, Michel Shami, Brenda K. Arrington, Keri S. Neuling, Ashaki Meeks, Natalie R. Garcia, Kayla Blair, Ginger K. Rhymes, Janet Medrano, Judy E. Kim, David V. Weinberg, Kimberly E. Stepien, Thomas B. Connor, Vesper V. Williams, Tracy L. Kaczanowski, Krissa L. Packard, Judy Flanders, Vicki Barwick, Pat A. Winter, Joseph R. Beringer, Kathy J. Selchert, John T. Lehr, Elaine Rodriguez-Roman, Teri Jones, Martha Eileen Haddox, Mark Pena, Brenda Hernandez, Clement K. Chan, Maziar Lalezary, Steven G. Lin, Kimberly S. Walther, Tiana Gonzales, Lenise E. Myers, Kenneth M. Huff, Richard Chace, Sunny Kallay, Kirsten Stevens, Nicole Dolbec, Ronda Baker-Hill, Janea Surette, Steven J. Rose, Brian P. Connolly, Ernest G. Guillet, Edward F. Hall, Margaret M. Yagoda, Mary Jo Doran, Mindy Burgess, Ann Reynard, Margaret Powers, Joe Territo, Calvin E. Mein, Moises A. Chica, R. Gary Lane, Sarah Elizabeth Holy, Lita Kirschbaum, Vanessa D. Martinez, Jaynee Baker, Christa G. Kincaid, Elaine Castillo, Christopher Sean Wienecke, Sara L. Schlichting, Brenda Nakoski, Kenneth R. Diddie, Deborah M. Cadwell, Louise Van Arsdale, Taryn F. Boisvert, Joyce Galonsky, Susie O'Hayer, Melissa L. Johnson, Frank J. McCabe, Brad J. Baker, Melvyn H. Defrin, Marie V. Lampson, Heather Pratte, Selena A. Baron, Aundrea S. Borelli, Frederick H. Davidorf, Michael B. Wells, Susie Chang, John Byron Christoforidis, Alan D. Letson, Jill A. Salerno, Jerilyn G. Perry, Stephen E. Shelley, Patrick J. Fish, Michael H. Scott, James A. Dixon, Shannon R. Walsh, Philomina M. Ozpirincci, Brenda L. Tebon, Marcia J. Moyle, Michael R. Pavlica, Noelle S. Matta, Cristina M. Brubaker, Alyson B. Backer, Neelakshi Bhagat, Catherine Fay, Tatiana Mikheyeva, Michael Lazar, Janie D. Ellenberger, Beth Malpica, Alexander J. Brucker, Benjamin J. Kim, Brian L. VanderBeek, Sheri Drossner, Joan C. DuPont, Rebecca Salvo, Stephanie B. Engelhard, Jim M. Berger, Sara Morales, Beth Serpentine, Paul L. Kaufman, Jessica D. McCluskey, Kathy T. Wynne, Julian Jordan, Brandun Watson, Robert S. Wirthlin, Eric S. Guglielmo, Eileen A. Dittman, Dylan C. Waidelich, Cristofer J. Garza, Adeline M. Stone, Ashley Nicole Oakes, Ivan J. Suner, Mark E. Hammer, Marc C. Peden, Janet R. Traynom, Rochelle DenBoer, Heidi Vargo, Susan Ramsey, Anita Kim Malzahn, Debra Jeffres, Nauman A. Chaudhry, Sumit P. Shah, Gregory M. Haffner, Emiliya German, Shannan Moreau, Laura A. Fox, Jennifer M. Matteson, JoAnna L. Pelletier, Alison Fontecchio, Emily Morse, Greg McNamara, Marie Grace Laglivia, Marissa L. Scherf, Angela LaPre, Justin A. Cocilo, Arup Das, Linda Friesen, Michele Franco, Johnny Lucero, Melissa Frazier, Robert Laviolette, Umar Khalil Mian, Rebecca L. Riemer, Evelyn Koestenblatt, Louise V. Wolf, Christine Kim, Irina Katkovskaya, Erica Otoo, Kevin A. Ellerbe, Kenneth Boyd, Caroline Costa, Paul Andrew Edwards, Hua Gao, Thomas Hessburg, Uday Desai, Janet Murphy, Mary K. Monk, Julianne Hall, Melina Mazurek, Katie M. Ventimiglia, Brian A. Rusinek, Bradley A. Stern, Kris Brouhard, Katie M. Weier, Megan Allis, Jenny Shaken, Nicole M. Massu, Tracy A. Troszak, David Burley, Abdhish R. Bhavsar, Geoffrey G. Emerson, Jacob M. Jones, Tracy A. Anderson, Andrea Gilchrist, Matt D. Peloquin, Gaid Gaid, Yang Vang, Samantha Ryan, Denise Vang, Alanna C. Evans, Tonja Scherer, Howard S. Lazarus, Debra Paige Bunch, Liana C. Davis, Kelly Booth, Margaret Trimble, Mary A. Bledsaw, Jay Moore, Daniel F. Rosberger, Sandra Groeschel, Miriam A. Madry, Nikoletta DiGirolamo, Dustin Pressley, Robert Santora, Yenelda M. Gomez, Karl R. Olsen, Robert L. Bergren, P. William Conrad, Pamela P. Rath, Avni Patel Vyas, Judy C. Liu, Lori A. Merlotti, Jennifer L. Chamberlin, Holly M. Mechling, Mary E. Kelly, Kellianne Marfisi, Kimberly A. Yeckel, Veronica L. Bennett, Christina M. Schultz, Grace A. Rigoni, Julie Walter, Missy A. Forish, Amanda Fec, Courtney L. Foreman, David Steinberg, Keith D. McBroom, Melvin C. Chen, Marc H. Levy, Waldemar Torres, Peggy Jelemensky, Tara L. Raphael, Joann Rich, Mark Sneath, James L. Kinyoun, Gurunadh Atmaram Vemulakonda, Susan A. Rath, Patricia K. Ernst, Juli A. Pettingill, Ronald C. Jones, Brad C. Clifton, James D. Leslie, Sharon D. Solomon, Lisa K. Levin, Deborah Donohue, Mary Frey, Lorena Larez, Keisha Murray, Rita L. Denbow, Janis Graul, David Emmert, Charles Herring, Nick Rhoton, Joe Belz, Alice T. Lyon, Rukhsana G. Mirza, Amanda M. Krug, Carmen Ramirez, Lori Kaminski, Anna Liza M. Castro-Malek, Amber N. Mills, Zuzanna Rozenbajgier, Marriner L. Skelly, Evica Simjanoski, Andrea R. Degillio, Jennifer I. Lim, Felix Y. Chau, Marcia Niec, Tametha Johnson, Yesenia Ovando, Mark Janowicz, Catherine Carroll, Jeffrey G. Gross, Barron C. Fishburne, Amy M. Flowers, Riley Stroman, Christen Ochieng, Angelique S.A. McDowell, Ally M. Paul, Randall L. Price, John H. Drouilhet, Erica N. Lacaden, Deborah J. Nobler, Howard L. Cummings, Deanna Jo Long, Ben McCord, Jason Robinson, Jamie Swift, Julie P. Maynard, Patricia J. Pahk, Hannah Palmer-Dwore, Dipali H. Dave, Mariebelle Pacheco, Barbara A. Galati, Eneil Simpson, Andrew J. Barkmeier, Diane L. Vogen, Karin A. Berg, Shannon L. Howard, Jean M. Burrington, Jessica Ann Morgan, Joan T. Overend, Shannon Goddard, Denise M. Lewison, Jaime L. Tesmer, Craig Michael Greven, Joan Fish, Cara Everhart, Mark D. Clark, David T. Miller, George Baker Hubbard, Jiong Yan, Blaine E. Cribbs, Linda T. Curtis, Judy L. Brower, Jannah L. Dobbs, Debora J. Jordan, Baseer U. Ahmad, Suber S. Huang, Hillary M. Sedlacek, Cherie L. Hornsby, Lisa P. Ferguson, Kathy Carlton, Kelly A. Sholtis, Peggy Allchin, Claudia Clow, Mark A. Harrod, Geoffrey Pankhurst, Irit Baum-Rawraway, Stacie A. Hrvatin, Ronald C. Gentile, Alex Yang, Wanda Carrasquillo-Boyd, Robert Masini, Chander N. Samy, Robert J. Kraut, Kathy Shirley, Linsey Corso, Karen Ely, Elizabeth Scala, Stewart Gross, Vanessa Alava, Eyal Margalit, Donna G. Neely, Maria Blaiotta, Lori Hagensen, April E. Harris, Rita L. Lennon, Denice R. Cota, Larry Wilson, Lloyd P. Aiello, Roy W. Beck, Susan B. Bressler, Kakarla V. Chalam, Ronald P. Danis, Bambi J. Arnold-Bush, Frederick Ferris, Talat Almukhtar, Brian B. Dale, Alyssa Baptista, Crystal Connor, Jasmine Conner, Sharon R. Constantine, Kimberly Dowling, Simone S. Dupre, Allison R. Ayala, Meagan L. Huggins, Seidu Inusah, Paula A. Johnson, Brenda L. Loggins, Shannon L. McClellan, Michele Melia, Eureca Battle, Cynthia R. Stockdale, Danielle Stanley, Glenn Jaffe, Brannon Balsley, Michael Barbas, Russell Burns, Dee Busian, Ryan Ebersohl, Cynthia Heydary, Sasha McEwan, Justin Myers, Amanda Robertson, Kelly Shields, Garrett Thompson, Katrina Winter, Ellen Young, Matthew D. Davis, Yijun Huang, Barbara Blodi, Amitha Domalpally, James Reimers, Pamela Vargo, Hugh Wabers, Dawn Myers, Daniel Lawrence, James Allan, Andrew Antoszyk, Scott Friedman, Ingrid U. Scott, Eleanor Schron, Donald F. Everett, Päivi H. Miskala, John Connett, Gary Abrams, Deborah R. Barnbaum, Harry Flynn, Ruth S. Weinstock, Charles P. Wilkinson, Stephen Wisniewski, Saul Genuth, Robert Frank, Frederick L. Ferris, Glenn J. Jaffe, Abdhish Bhavsar, Joseph Googe, Andreas Lauer, and Ashley McClain

Subjects
Male, Vascular Endothelial Growth Factor A, medicine.medical_specialty, Visual acuity, genetic structures, Bevacizumab, Recombinant Fusion Proteins, Visual Acuity, 030232 urology & nephrology, Angiogenesis Inhibitors, Enzyme-Linked Immunosorbent Assay, Gastroenterology, Macular Edema, Article, law.invention, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, Ranibizumab, Internal medicine, medicine, Humans, Stroke, Aflibercept, Diabetic Retinopathy, business.industry, Middle Aged, medicine.disease, Confidence interval, Vascular endothelial growth factor, Ophthalmology, Receptors, Vascular Endothelial Growth Factor, Treatment Outcome, chemistry, Intravitreal Injections, Retreatment, 030221 ophthalmology & optometry, Female, medicine.symptom, business, Tomography, Optical Coherence, Follow-Up Studies, medicine.drug
Abstract

PURPOSE: Assess systemic vascular endothelial growth factor-A (VEGF) levels after treatment with intravitreous aflibercept, bevacizumab or ranibizumab. DESIGN: Comparative-effectiveness trial with participants randomly assigned to 2-mg aflibercept, 1.25-mg bevacizumab, or 0.3-mg ranibizumab following a retreatment algorithm. PARTICIPANTS: Participants with available plasma samples (N=436) METHODS: Plasma samples were collected before injections at baseline, 4-week, 52-week and 104-week visits. In a pre-planned secondary analysis, systemic free-VEGF levels from an ELISA immunoassay were compared across anti-VEGF agents and correlated with systemic side effects. MAIN OUTCOME MEASURES: Changes in the natural log (ln) of plasma VEGF levels. RESULTS: Baseline free-VEGF levels were similar across all 3 groups. At 4 weeks, mean ln(VEGF) changes were −0.30±0.61, −0.31±0.54, −0.02±0.44 pg/ml for the aflibercept, bevacizumab, and ranibizumab groups, respectively. The adjusted differences between treatment groups (adjusted CI; P-value) were −0.01 (−0.12, +0.10; P=0.89), −0.31 (−0.44, −0.18; P

Published
2018
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7. INTRAVITREAL AFLIBERCEPT INJECTION FOR CHOROIDAL NEOVASCULARIZATION DUE TO PRESUMED OCULAR HISTOPLASMOSIS SYNDROME

Author

Daniel M. Miller, Dennis M. Marcus, John W. Kitchens, Megan L. Kingdon, Ken Ivey, Brian W. Toussaint, and Diana M Holcomb

Subjects
Adult, Male, medicine.medical_specialty, Visual acuity, Randomization, genetic structures, Recombinant Fusion Proteins, Presumed ocular histoplasmosis syndrome, Angiogenesis Inhibitors, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Endophthalmitis, Ophthalmology, Humans, Medicine, 030212 general & internal medicine, Histoplasmosis, Aged, Aflibercept, business.industry, General Medicine, Middle Aged, Eye infection, medicine.disease, Choroidal Neovascularization, eye diseases, Receptors, Vascular Endothelial Growth Factor, Choroidal neovascularization, Intravitreal Injections, Vitreous hemorrhage, 030221 ophthalmology & optometry, Female, sense organs, medicine.symptom, business, Eye Infections, Fungal, medicine.drug
Abstract

PURPOSE To evaluate intravitreal aflibercept injection (IAI) in patients with presumed ocular histoplasmosis syndrome and choroidal neovascularization. METHODS Open-label randomized Phase I/II study of IAI in patients with presumed ocular histoplasmosis syndrome-related choroidal neovascularization. Thirty-nine eyes from 39 patients were randomized in a 1:1 ratio to 2 groups. The Sustained Group eyes (n = 19) underwent monthly IAI for 3 months, then mandatory IAI every 2 months for 12 months (with an option for monthly PRN dosing, if needed). The PRN Group eyes (n = 20) received 1 IAI at randomization, then monthly PRN IAI for 12 months. RESULTS Thirty-nine eyes (19 eyes Sustained Group and 20 eyes PRN Group) were randomized. Average age of participants was 50 years (19-75), with 16 men and 23 women. Ten, 12, and 17 eyes demonstrated extrafoveal, juxtafoveal, and subfoveal choroidal neovascularization, respectively. All eyes in both groups received IAI at baseline, with the Sustained and PRN groups receiving on an average 7.5 (5-11) and 4.6 (1-10) injections, respectively, over the 12 months. At baseline, overall average visual acuity was 68 letters (13-87 letters) with Snellen equivalent of 20/42 (20/20-20/160). At 12-month follow-up, Sustained Group's average visual acuity was 84.9 letters (74-94) and Snellen equivalent was 20/21 (20/13-20/32), indicating an average improvement of 12 letters (6 letters loss to 36 letters gain) (P < 0.01). The PRN Group's 12-month average visual acuity was 80.9 letters (60-94) and Snellen equivalent was 20/26 (20/13-20/63), indicating an average gain of 19 letters (4-75) (P < 0.01). Mean baseline central subfield thickness (CST) was 374 μm and mean 1-year CST was 260 μm (P < 0.01) among all study participants. The Sustained Group's mean baseline CST was 383 μm and mean 12-month CST was 268 μm (P < 0.01). Mean baseline CST of the PRN Group was 360.8 μm, with the final mean CST of 260.5 μm (P < 0.01). No reported endophthalmitis, retinal tears, detachments, vitreous hemorrhage, nor adverse thrombotic events were reported. CONCLUSION Intravitreal aflibercept resulted in improved visual and anatomical outcomes with a favorable safety profile. PRN IAI dosing required less injections with similar visual and anatomical outcomes compared with sustained dosing.

Published
2018
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8. External Choroidal Drainage Using Direct Visualization

Author

Shriji Patel, Laura L Snyder, and John W. Kitchens

Subjects
medicine.medical_specialty, Conjunctiva, Drainage procedure, genetic structures, medicine.medical_treatment, Vitrectomy, Ophthalmologic Surgical Procedures, chemistry.chemical_compound, Ophthalmology, medicine, Humans, Aged, Intraocular hemorrhage, business.industry, Retinal, Choroid Diseases, medicine.disease, eye diseases, Shunt (medical), medicine.anatomical_structure, chemistry, Drainage, Female, sense organs, Epiretinal membrane, business, Ophthalmologic Surgical Procedure
Abstract

Laura L. Snyder Shriji N. Patel A woman in her 60s with a functional glaucoma tube shunt presented after vitrectomy for epiretinal membrane peeling with symptomatic choroidal effusions not responsive to medical therapy. She underwent a minimally invasive, transconjunctival choroidal drainage procedure, which was directly visualized under a widefield viewing system to prevent intraocular hemorrhage or retinal penetration of the needle. This allowed for preservation of her conjunctiva, restoration of normal intraocular pressure by temporary blockage of her tube shunt with a viscoelastic, and resolution of her choroidal effusions.

Published
2019
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9. PRN Ranibizumab in the Treatment of Choroidal Neovascularization Secondary to Ocular Histoplasmosis

Author

Diana M Holcomb, Edward H. Wood, John W. Kitchens, Ricky D Isernhagen, William J Wood, Thomas W Stone, and Ryan J. Whitted

Subjects
Adult, Male, Vascular Endothelial Growth Factor A, 0301 basic medicine, medicine.medical_specialty, Visual acuity, genetic structures, Visual Acuity, Angiogenesis Inhibitors, Histoplasmosis, law.invention, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Pro re nata, Ranibizumab, Ophthalmology, Humans, Medicine, Prospective Studies, Prospective cohort study, Aged, Dose-Response Relationship, Drug, Choroid, business.industry, Middle Aged, Eye infection, medicine.disease, Choroidal Neovascularization, eye diseases, Treatment Outcome, 030104 developmental biology, Choroidal neovascularization, Intravitreal Injections, 030221 ophthalmology & optometry, Female, medicine.symptom, business, Eye Infections, Fungal, Tomography, Optical Coherence, Follow-Up Studies, medicine.drug
Abstract

BACKGROUND AND OBJECTIVE: Ranibizumab (Lucentis; Genentech, South San Francisco, CA) is used off-label for the treatment of choroidal neovascularization secondary to ocular histoplasmosis syndrome (OHS). This study prospectively evaluates the safety and efficacy of two treatment paradigms utilizing ranibizumab 0.5 mg: one or three initial injections followed by monthly visits with PRN treatment through Month 12. PATIENTS AND METHODS: In this prospective, open-label study, 21 subjects were evaluated monthly and retreated during the pro re nata treatment phase if specific criteria were met, including loss of vision, increase in subretinal fluid, or hemorrhage. Adverse events, best-corrected visual acuity (BCVA), and central subfield retinal thickness (CST) were evaluated. RESULTS: No adverse events were observed. Mean BCVA improved in both groups by approximately 2 lines, and mean CST decreased by approximately 100 μm at month 12. The number of injections was the same (5.7 and 5.8 injections). CONCLUSION: Results suggest that ranibizumab is safe and efficacious for treatment of CNV secondary to OHS. [ Ophthalmic Surg Lasers Imaging Retina . 2018;49:20–26.]

Published
2018
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10. Safety and Efficacy of Subretinally Administered Palucorcel for Geographic Atrophy of Age-Related Macular Degeneration: Phase 2b Study

Author

Jeffrey S, Heier, Allen C, Ho, Michael A, Samuel, Tom, Chang, Christopher D, Riemann, John W, Kitchens, Jason S, Slakter, Yannek I, Leiderman, Rand, Spencer, George A, Williams, Sheila B, Hickson-Curran, Michael, Keane, and James S, Baldassarre

Subjects
Treatment Outcome, Fundus Oculi, Geographic Atrophy, Cell- and Tissue-Based Therapy, Visual Acuity, Wet Macular Degeneration, Humans, Macula Lutea, Fluorescein Angiography, Injections, Intraocular, Retina, Tomography, Optical Coherence, Follow-Up Studies
Abstract

To evaluate safety and successful use of a novel subretinal delivery system and suprachoroidal surgical approach and safety and activity of human umbilical tissue-derived cells (palucorcel) via a novel delivery system in patients with geographic atrophy (GA).Multicenter, open-label phase 2b study.Participants were 55 to 90 years with GA secondary to age-related macular degeneration (AMD) and best-corrected visual acuity (BCVA) of 20/80 to 20/800. Exclusion criteria included neovascular AMD in the intervention eye, glaucoma with intraocular pressure of 25 mmHg or more, or other significant ophthalmologic conditions.Participants received a subretinal injection of palucorcel, 3.0 × 10Safety assessments included treatment-emergent adverse events (AEs), immunologic assessments, and ophthalmologic evaluations. Efficacy was evaluated as change in mean number of BCVA letters from baseline, proportion of participants gaining 15 BCVA letters or more, and growth rate of GA lesions at 12 months.Surgery and palucorcel administration were performed in 21 participants at 8 sites by 8 different surgeons. At baseline, median total area of GA was 13.4 mmPalucorcel was delivered successfully to the targeted subretinal site using a novel delivery system and suprachoroidal approach for most participants; however, improvement in GA area, retardation of growth, or visual acuity were not demonstrated.

Published
2019

11. Intravitreal Combined Aflibercept + Anti-Platelet-Derived Growth Factor Receptor β for Neovascular Age-Related Macular Degeneration: Results of the Phase 2 CAPELLA Trial

Author

Jeffrey S, Heier, Charles C, Wykoff, Nadia K, Waheed, John W, Kitchens, Sunil S, Patel, Robert, Vitti, Lorah, Perlee, Karen W, Chu, Sergio, Leal, Friedrich, Asmus, Vladimir, Son, Thomas, Schmelter, and David M, Brown

Subjects
Aged, 80 and over, Male, Vascular Endothelial Growth Factor A, Recombinant Fusion Proteins, Visual Acuity, Angiogenesis Inhibitors, Choroidal Neovascularization, Receptor, Platelet-Derived Growth Factor beta, Receptors, Vascular Endothelial Growth Factor, Treatment Outcome, Double-Blind Method, Intravitreal Injections, Wet Macular Degeneration, Humans, Drug Therapy, Combination, Female, Aged
Abstract

To compare the efficacy and safety of intravitreal aflibercept + anti-platelet-derived growth factor receptor β (PDGFRβ) combination with intravitreal aflibercept injection (IAI) monotherapy in patients with treatment-naïve neovascular age-related macular degeneration (nAMD).Phase 2, randomized, double-masked study.A total of 505 patients (eyes) with nAMD.Patients were randomized 1:2:2 to low-dose combination intravitreal anti-PDGFRβ 1 mg and aflibercept 2 mg (LD combo), high-dose combination intravitreal anti-PDGFRβ 3 mg and aflibercept 2 mg (HD combo), or IAI alone every 4 weeks through week 12. At week 12, patients in the HD combo and IAI groups were re-randomized to continue as assigned or switch to HD combo → IAI or IAI → HD combo and dosed every 4 weeks through week 28. During weeks 28 to 52, patients received treatment as needed per prespecified criteria. This report presents efficacy through week 28 and safety through week 52.Mean best-corrected visual acuity (BCVA) change from baseline at week 12 (primary end point).At week 12, mean BCVA gains from baseline were 5.8, 5.8, and 7.5 letters with LD combo, HD combo, and IAI, respectively (P = 0.21 for LD combo and P = 0.10 for HD combo vs. IAI). The corresponding proportions of eyes that gained ≥15 letters were 12%, 19%, and 22%, respectively. Mean reductions in central retinal thickness from baseline were 126.1, 127.1, and 126.9 μm, respectively. Proportions of eyes with complete resolution of fluid from baseline were 35%, 24%, and 42%, respectively. Vision and anatomic outcomes at week 28 were consistent with the week 12 results. Through week 52, the incidence of intraocular inflammation was 1.0%, 7.5%, 2.1%, 2.1%, and 0%, respectively. The incidence of Anti-Platelet Trialists' Collaboration-defined arterial thromboembolic events was 1.9%, 0.9%, 1.1%, 2.1%, and 1.9%, respectively.Intravitreal aflibercept + anti-PDGFRβ did not improve BCVA over IAI alone. Anatomic outcomes evaluating complete fluid resolution favored IAI. Adverse events were consistent with the reported IAI safety profile, except for a higher frequency of intraocular inflammation in the HD combo group.

Published
2018

12. Observational study of subclinical diabetic macular edema

Author

Janis Graul, Craig N. Kelso, Dennis B. Backes, Paul G. Arrigg, Collin L. DuCoty, John M. Bourg, David Emmert, Caldwell W. Smith, Helen K. Li, Ann Kopple, Robert H. Janigian, Terri Cain, Brian A. Rusinek, Donna J. Chesbrough, Susan Rath, Jennifer V. Helms, Michael J. Elman, Joe Fischer, Sheila M. Rock, Jo Ann Starr, Erika Banalewicz, Michelle Buck, Manjot K. Gill, Peter Sotirakos, Teresa Coffey, Paul M. Beer, Debbie M. Brown, David J. Browning, Judy E. Kim, Amy M. Flowers, Laima M. O'Donnell, Stephen T. Blevins, Giorya Shabi Andreani, Sylvia Varadian, Michele Melia, Charisse Whitney, Garvin H. Davis, Linda M. Davis, Allen McKinney, Susan B. Bressler, James L. Kinyoun, Michele E. Powers, Happy Spillar, Mary B. Savell, Jeanette Graf, Thomas W. Stone, Kenneth M. Huff, Janet Murphy, Judith L. Cruz, John W. Kitchens, Deborah K. Schlossman, Sandra U. Castillo, William J. Wood, Jeanne Van Arsdall, Roy W. Beck, Stacy Carpenter, Alex L. Nagle, Sandra Henriques, Jeffrey G. Gross, Edward A. Slade, Andrew N. Antoszyk, Heather L. Murphy, Joseph M. Googe, Harold A. Woodcome, Kelly A. Blackmer, Michelle D. Sloan, Jennifer K. Sun, Randall L. Price, Jon M. Braverman, Heidi K. Lovit, Timothy J. Murtha, Christina T. Higdon, Angella S. Karow, Adam R. Glassman, Julie P. Berry, Alice T. Lyon, Deborah Donohue, Loraine Clark, S. Shah, Joseph R. Beringer, Janelle Dane Zapata, Michael D. McOwen, Jonathan Shankle, Robert W. Cavicchi, Kimberly S. Walther, Eugenia Olmeda, Melissa K. Cowen, Joanne E. Bache, Leif S. Ryman, James D. Leslie, Denise Garza, Dennis P. Han, Karen Sjoblom, Margaret E. Stockman, Howard L. Cummings, Dawn Alvarez, Uma M. Balasubramaniam, Tracy A. Troszak, Brad C. Clifton, Paul A. Blais, Mary Frey, Paul A. Edwards, William J. Wirostko, Rosemary C. Rhodes, Clement K. Chan, Danielle R. Brooks, Theresa M. Butcher, K. M. Miller, Scott M. Friedman, Sasha I. Montalvo, Amber Crocker, Pamela V. Singletary, Sharon D. Solomon, Steve Carlton, Jolleen S. Key, Dawn M. Ryan, S. B. Bressler, L. Kaminski, Deanna Jo Long, Nancy Gore, Donna McClain, Magdalena G. Krzystolik, George S. Sharuk, Angela K. Price, Cecile Hunt, Antonio P. Ciardella, Lori E. Ackatz, Mark Hamel, Sandra West, Neil M. Bressler, Damanda A. Fagan, and Judy Flanders

Subjects
Male, medicine.medical_specialty, endocrine system diseases, genetic structures, Diabetic macular edema, Visual Acuity, Macular Edema, Retina, Primary outcome, Diabetes mellitus, Ophthalmology, Edema, medicine, Humans, Aged, Subclinical infection, Diabetic Retinopathy, business.industry, Organ Size, Middle Aged, medicine.disease, eye diseases, Confidence interval, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Disease Progression, Female, Observational study, sense organs, medicine.symptom, Slit lamp biomicroscopy, business, Tomography, Optical Coherence
Abstract

To determine the rate of progression of eyes with subclinical diabetic macular edema (DME) to clinically apparent DME or DME necessitating treatment during a 2-year period. In all, 43 eyes from 39 study participants with subclinical DME, defined as absence of foveal center edema as determined with slit lamp biomicroscopy but a center point thickness (CPT) between 225 and 299 μm on time domain (Stratus, Carl Zeiss Meditec) optical coherence tomography (OCT) scan, were enrolled from 891 eyes of 582 subjects screened. Eyes were evaluated annually for up to 2 years for the primary outcome, which was an increase in OCT CPT of at least 50 μm from baseline and a CPT of at least 300 μm, or treatment for DME (performed at the discretion of the investigator). The cumulative probability of meeting an increase in OCT CPT of at least 50 μm from baseline and a CPT of at least 300 μm, or treatment for DME was 27% (95% confidence interval (CI): 14%, 38%) by 1 year and 38% (95% CI: 23%, 50%) by 2 years. Although subclinical DME may be uncommon, this study suggests that between approximately one-quarter and one-half of eyes with subclinical DME will progress to more definite thickening or be judged to need treatment for DME within 2 years after its identification.

Published
2012
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13. Comprehensive Review of Ocular and Systemic Safety Events with Intravitreal Aflibercept Injection in Randomized Controlled Trials

Author

Desmond Thompson, Peter K. Kaiser, David S. Boyer, Namrata Saroj, Robert Vitti, Alyson J. Berliner, John W. Kitchens, Diana V. Do, and Andrea Gibson

Subjects
Recombinant Fusion Proteins, Angiogenesis Inhibitors, Retinal Neovascularization, Rate ratio, Macular Edema, law.invention, 03 medical and health sciences, Macular Degeneration, 0302 clinical medicine, Endophthalmitis, Clinical Trials, Phase II as Topic, Central retinal vein occlusion, Randomized controlled trial, law, Retinal Vein Occlusion, medicine, Humans, 030212 general & internal medicine, Adverse effect, Macular edema, Randomized Controlled Trials as Topic, Diabetic Retinopathy, business.industry, Macular degeneration, medicine.disease, Ophthalmology, Receptors, Vascular Endothelial Growth Factor, Clinical Trials, Phase III as Topic, Anesthesia, Intravitreal Injections, 030221 ophthalmology & optometry, Branch retinal vein occlusion, business
Abstract

Purpose To assess the ocular and systemic safety of intravitreal aflibercept injection (IAI) compared with controls in IAI trials in neovascular age-related macular degeneration (nAMD), macular edema following central retinal vein occlusion (MEfCRVO), macular edema following branch retinal vein occlusion (MEfBRVO), and diabetic macular edema (DME). Design Comprehensive review of 10 phase II and III trials of IAI in retinal diseases. Participants Patients were included from IAI trials in nAMD (CLEAR-IT 2 [52 weeks], VIEW 1 [96 weeks], VIEW 2 [96 weeks], VIEW 1 extension [208 weeks]); MEfCRVO (COPERNICUS [100 weeks], GALILEO [76 weeks]); MEfBRVO (VIBRANT [52 weeks]); and DME (DA VINCI [52 weeks], VIVID [100 weeks], VISTA [100 weeks]). Methods Rates were calculated as events/100 person-years at risk (PYR). When applicable, rate ratios (RRs) and 95% confidence intervals (CIs) were provided. Main Outcome Measures Outcomes included rates for intraocular inflammation, endophthalmitis, serious adverse events (SAEs), wound-healing complications, hypertension (HTN), adjudicated Anti-Platelet Trialists' Collaboration (APTC)–defined arterial thromboembolic events (ATEs) (nonfatal myocardial infarction, nonfatal stroke, and vascular death), and death from all causes. Results More than 4000 patients contributed >7000 PYR. For all outcomes, there were no meaningful differences between evaluated adverse event rates for IAI and controls. Overall intraocular inflammation rates were 2.37 (control) and 2.06 (IAI); overall RR was 0.87 (95% CI, 0.61–1.27). Overall endophthalmitis rates were 0.52 (control) and 0.22 (IAI); overall RR was 0.42 (95% CI, 0.18–1.03). Overall SAE rates were 23.09 (control) and 20.80 (IAI); overall RR was 0.90 (95% CI, 0.80–1.02). Overall rates of wound-healing complications were 0.17 (control) and 0.15 (IAI); overall RR was 0.85 (95% CI, 0.24–3.86). Overall HTN rates were 14.87 (control) and 11.27 (IAI), with an overall RR of 0.76 (95% CI, 0.65–0.89); HTN rates were highest in MEfBRVO and lowest in nAMD. For adjudicated APTC-defined ATEs, rates were 2.04 (control) and 2.19 (IAI), with an RR of 1.07 (95% CI, 0.73–1.61). Overall death rates were 1.16 (control) and 1.49 (IAI); overall RR was 1.28 (95% CI, 0.80–2.15). Conclusions Rates of selected ocular and systemic adverse events with IAI were similar to those of controls and similar across disease states in evaluated IAI trials. Intravitreal aflibercept injection was generally well tolerated in the patients evaluated.

Published
2016

14. Vitreous Vortex: A Unique Case of Vitreomacular Adhesion

Author

John W. Kitchens, Yi Jiang, and Michelle Buck

Subjects
Male, medicine.medical_specialty, Tissue Adhesion, Eye Diseases, business.industry, Epiretinal Membrane, Tissue Adhesions, Anatomy, medicine.disease, Vitreomacular adhesion, Vortex, Vitreous Body, Ophthalmology, Imaging, Three-Dimensional, medicine, Image Processing, Computer-Assisted, Humans, Epiretinal membrane, business, Tomography, Optical Coherence, Aged
Published
2015

15. INDOCYANINE GREEN–ASSISTED INTERNAL LIMITING MEMBRANE PEELING FOR MACULAR HOLES

Author

Elias C. Mavrofrides, John W. Kitchens, Alberto Salicone, William E. Smiddy, and William J. Feuer

Subjects
endocrine system, medicine.medical_specialty, genetic structures, business.industry, Internal limiting membrane, General Medicine, medicine.disease, Ilm peeling, eye diseases, body regions, Ophthalmology, chemistry.chemical_compound, chemistry, medicine, sense organs, business, Indocyanine green, Macular hole
Abstract

Background:Indocyanine green (ICG) staining facilitates definitive internal limiting membrane (ILM) peeling during macular hole surgery (MHS), but might cause toxicity.Purpose:To determine if ICG to assist in ILM peeling has an effect on anatomic or visual results in MHS with ILM peeling.Methods:Ret

Published
2006
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16. INDOCYANINE GREEN???ASSISTED INTERNAL LIMITING MEMBRANE PEELING FOR MACULAR HOLES

Author

Alberto Salicone, John W. Kitchens, William E. Smiddy, Elias C. Mavrofrides, and William J. Feuer

Subjects
Indocyanine Green, Male, medicine.medical_specialty, Visual acuity, genetic structures, medicine.medical_treatment, Visual Acuity, Vitrectomy, Ilm peeling, Basement Membrane, Retina, Injections, Closure rate, chemistry.chemical_compound, Ophthalmology, Humans, Medicine, Coloring Agents, Macular hole, Aged, Retrospective Studies, Staining and Labeling, business.industry, Internal limiting membrane, Epiretinal Membrane, General Medicine, Retinal Perforations, medicine.disease, eye diseases, Vitreous Body, body regions, chemistry, Multivariate Analysis, Toxicity, Female, sense organs, medicine.symptom, business, Indocyanine green
Abstract

Indocyanine green (ICG) staining facilitates definitive internal limiting membrane (ILM) peeling during macular hole surgery (MHS), but might cause toxicity.To determine if ICG to assist in ILM peeling has an effect on anatomic or visual results in MHS with ILM peeling.Retrospective, comparative review including primary analysis of 173 cases undergoing MHS. Visual acuityor=20/50,or=20/200, three-line visual acuity improvement, and anatomic success rates were analyzed as endpoints.The single operation hole closure rate was 87% with ICG versus 83% without ICG (P = 0.52). Postoperative median best-corrected visual acuity was 20/70 and 20/80 in the ICG and no ICG groups with median follow-up intervals of 8 and 9 months. The use of ICG was associated with a higher rate ofor=20/200, but ILM peeling and ICG use was not associated with better anatomic success, visual improvement, oror=20/50 visual acuity.ICG usage during macular hole surgery was not associated with worse visual outcomes, suggesting possible toxic effects reported are not clinically significant. If the ILM cannot be peeled effectively, ICG should be considered a safe option.

Published
2006
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17. Idiopathic macular hole with extensive subretinal fluid: Clinical and optical coherence tomography features before and after surgery

Author

John W. Kitchens, Andrew A. Moshfeghi, Carmen A. Puliafito, and Harry W. Flynn

Subjects
Male, medicine.medical_specialty, Visual acuity, genetic structures, Eye disease, Visual Acuity, Diagnostic Techniques, Ophthalmological, Optical coherence tomography, Vitrectomy, Ophthalmology, Preoperative Care, medicine, Humans, Macular edema, Macular hole, Aged, Retrospective Studies, Postoperative Care, Fluorocarbons, Retina, medicine.diagnostic_test, business.industry, Exudates and Transudates, Middle Aged, Retinal Perforations, medicine.disease, eye diseases, Body Fluids, Surgery, medicine.anatomical_structure, Maculopathy, Female, sense organs, medicine.symptom, business, Tomography, Optical Coherence, Retinopathy
Abstract

Purpose To report clinical and optical coherence tomography (OCT) features in patients with idiopathic macular hole and extensive subretinal fluid (extending at least 1 disk diameter from the center of the hole). Design Retrospective, consecutive, noncomparative case series. Methods The case records of two patients with idiopathic macular holes with extensive subretinal fluid were reviewed. Results Both patients presented with reduced visual acuity (20/200 and 20/400). OCT demonstrated attachment of the posterior hyaloid to the inner retina, a full-thickness macular hole, cystoid macular edema (CME), and extensive subretinal fluid. After surgery, both patients achieved macular hole closure and improvement in visual acuity (20/60 and 20/30). Postoperatively, OCT showed a normal foveal contour, complete hole closure, and resolution of the CME and subretinal fluid. Conclusions In patients with macular hole and extensive subretinal fluid, improved visual acuity and hole closure can be achieved. Preoperative OCT in these patients demonstrates vitreoretinal interface abnormalities, CME, and extensive subretinal fluid. These changes resolve postoperatively.

Published
2005
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18. PERIPAPILLARY CHOROIDAL NEOVASCULARIZATION ASSOCIATED WITH KENNY SYNDROME

Author

John W Kitchens

Subjects
medicine.medical_specialty, genetic structures, medicine.diagnostic_test, business.industry, Retinal, General Medicine, Retinal vascular tortuosity, Retinal photography, Fluorescein angiography, eye diseases, Kenny syndrome, Ophthalmology, chemistry.chemical_compound, Choroidal neovascularization, chemistry, medicine, Optic nerve, In patient, sense organs, medicine.symptom, business
Abstract

PURPOSE To report a case of Kenny-Caffey syndrome with peripapillary choroidal neovascularization. METHODS An observational case report with clinical findings demonstrated by wide-field retinal photographic and angiographic evaluation of a patient with Kenny-Caffey syndrome. RESULTS Wide-field retinal photography and fluorescein angiography showed characteristic findings seen in Kenny-Caffey syndrome (crowded optic nerves, retinal vascular tortuosity). In addition, the previously undocumented finding of peripapillary choroidal neovascularization is demonstrated. CONCLUSION The development of peripapillary choroidal neovascularization can occur in patients with Kenny-Caffey syndrome. The development of this finding may be secondary to abnormalities of the optic nerve inherent in this rare disorder.

Published
2010
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19. Active aspiration of suprachoroidal hemorrhage using a guarded needle

Author

Darius M. Moshfeghi, Natalia Fijalkowski, Efrem D. Mandelcorn, and John W. Kitchens

Subjects
Suction (medicine), Pars plana, Novel technique, Choroid Hemorrhage, medicine.medical_specialty, business.industry, medicine.medical_treatment, fungi, food and beverages, Vitrectomy, Suprachoroidal hemorrhage, Exudates and Transudates, Ophthalmologic Surgical Procedures, Suction, Choroid hemorrhage, Surgery, medicine.anatomical_structure, Suprachoroidal space, Needles, medicine, Humans, Female, business, Scleral buckling, Aged
Abstract

BACKGROUND AND OBJECTIVE: To describe a novel technique using a guarded needle to drain suprachoroidal hemorrhage. PATIENTS AND METHODS: A guarded needle is used to drain suprachoroidal hemorrhage under direct microscope visualization. A scleral buckling sleeve is used to create a guarded 26-gauge needle to avoid over-penetration of the needle beyond the suprachoroidal space. Active extrusion can be used to drain suprachoroidal blood. RESULTS: The authors report two cases in which active aspiration using a guarded needle was successful in draining suprachoroidal hemorrhage without complications. In both cases, the vitreous cavity could be restored, allowing for subsequent pars plana vitrectomy. CONCLUSION: The technique of active aspiration using a guarded needle optimizes surgeon control of suprachoroidal hemorrhage drainage and also has the added benefit of easy transition to secondary vitrectomy after drainage has been completed. [ Ophthalmic Surg Lasers Imaging Retina . 2014;45:150–152.]

Published
2013

20. Neovascular AMD with marked macular fluid and rapid response to anti-VEGF therapy

Author

Harry W. Flynn, Jonathan S. Chang, John W. Kitchens, and Edward H. Wood

Subjects
Male, Vascular Endothelial Growth Factor A, medicine.medical_specialty, Visual acuity, genetic structures, Bevacizumab, Visual Acuity, Angiogenesis Inhibitors, Antibodies, Monoclonal, Humanized, Optical coherence tomography, Ophthalmology, Ranibizumab, Medicine, Humans, Rapid response, Aged, Anti vegf, Aged, 80 and over, medicine.diagnostic_test, business.industry, Subretinal Fluid, Macular degeneration, medicine.disease, eye diseases, Treatment Outcome, Intravitreal Injections, Wet Macular Degeneration, Female, sense organs, Subretinal fluid, medicine.symptom, business, Tomography, Optical Coherence, medicine.drug
Abstract

The authors describe the clinical management and spectral-domain optical coherence tomography (SD-OCT) findings of three unusual cases of neovascular age-related macular degeneration (AMD). Each patient presented with decreased vision and a diagnosis of neovascular AMD, with SD-OCT findings of marked macular fluid. Macular fluid was noted to be subretinal fluid, pigment epithelial detachment, or both. In each case, visual acuity improved and the fluid resolved rapidly with monthly anti–vascular endothelial growth factor therapy. [ Ophthalmic Surg Lasers Imaging Retina . 2014;45:175–178.]

Published
2013

21. Triamcinolone acetonide preparations: impact of crystal size on in vitro behavior

Author

Darius M. Moshfeghi, Andrew A. Moshfeghi, Steven R. Sanislo, Hiroyuki Nomoto, John W. Kitchens, and Alex K. Nugent

Subjects
Triamcinolone acetonide, Balanced salt solution, Absorption (skin), In Vitro Techniques, Triamcinolone Acetonide, law.invention, Crystal, law, Spectrophotometry, Image Processing, Computer-Assisted, Medicine, Injectable Suspension, Crystallization, Glucocorticoids, Microscopy, medicine.diagnostic_test, business.industry, Preservatives, Pharmaceutical, General Medicine, In vitro, Ophthalmology, Ophthalmic Solutions, business, Nuclear chemistry, medicine.drug
Abstract

To characterize the in vitro behavior of three preparations of triamcinolone acetonide (TA).Three preparations of TA were mixed with Balanced Salt Solution Plus: commercially available TA (Kenalog 40, Bristol-Myers Squibb, Princeton, NJ), compounded preservative-free triamcinolone acetonide (PFTA, New England Compounding Center, Framingham, MA), and triamcinolone acetonide injectable suspension (TAIS, TRIESENCE, Alcon, Inc., Fort Worth, TX). We determined the mean number of crystalline aggregates per high-power deconvolution microscopy field, largest aggregate area, and spectroscopic photometric absorption.Preservative-free triamcinolone acetonide had larger mean number of aggregates compared with TA (time 0 P = 0.002, 10 minutes P0.001) and TAIS (time 0 P0.001, 10 minutes P = 0.003). Aggregate size varied at both 0 and 10 minutes: TAISTAPFTA. Spectroscopic photometric absorption decreased in direct correlation to aggregate size over time for all three preparations.In vitro, PFTA in Balanced Salt Solution Plus had more aggregates of smaller size than either TA or TAIS. By contrast, TAIS had much larger aggregate size than both PFTA and TA, and this increased over time. These findings correlate with the clinical observations that PFTA and TA tend to disperse throughout the vitreous, whereas TAIS tends to conglomerate and gravitate toward the most dependent portion of the eye in a globular fashion.

Published
2009

22. Retinal breaks observed during pars plana vitrectomy

Author

Jeffrey K. Moore, Giovanni Gregorio, William E. Smiddy, John W. Kitchens, and Elias C. Mavrofrides

Subjects
Pars plana, Adult, Male, medicine.medical_specialty, Retinal breaks, Adolescent, medicine.medical_treatment, Vitrectomy, Cryosurgery, chemistry.chemical_compound, Postoperative risk, Risk Factors, Ophthalmology, medicine, Humans, Aged, Retrospective Studies, Aged, 80 and over, Retina, Intraoperative Care, business.industry, Incidence (epidemiology), Incidence, Retinal Detachment, Retinal detachment, Retinal, Middle Aged, medicine.disease, Retinal Perforations, Surgery, medicine.anatomical_structure, chemistry, Female, business
Abstract

Purpose To quantitate the frequency and features of retinal breaks discovered at the time of vitrectomy and to evaluate the outcomes with prophylactic treatment. Design A consecutive, single-surgeon, retrospective, observational case series from a two-year period. Methods Medical records were reviewed for all patients who underwent primary, standard, three-port pars plana vitrectomy (PPV) between January 1, 2000, and December 31, 2001. Intraoperative findings recorded included the number, location, and categorization of retinal breaks and their method of management. Postoperative features recorded included the presence or absence of a retinal detachment (RD). Results There were 65 retinal breaks found in 48 (11.6%) of 415 eyes and included 30 (7.2%) eyes with definite breaks, nine (2.2%) with suspicious breaks, and nine (2.2%) with probably preexisting breaks. Breaks that were described as being large (n = 5) were more commonly associated with the right-hand sclerotomy (P = .041), although other categories of breaks were not. After surgery, the overall incidence of RD was 2.2% (nine of 415 eyes). The rate of RD among the 48 eyes with retinal breaks (of any category) was also 2.1% (one eye). All RDs in this series occurred more than three months after initial vitrectomy and, accordingly, were probably unrelated to retinal breaks that occurred during surgery. Conclusions Recognition of retinal breaks and intraoperative treatment with retinopexy and air–fluid exchange during vitrectomy reduces the postoperative risk of RD to that among eyes without observed intraoperative retinal breaks.

Published
2006

24. Erratum: Observational study of subclinical diabetic macular edema

Author

James L. Kinyoun, Michele E. Powers, Sandra West, Neil M. Bressler, Susan Rath, Clement K. Chan, Heidi K. Lovit, Eugenia Olmeda, Danielle R. Brooks, James D. Leslie, Ann Kopple, Amy M. Flowers, David J. Browning, Erika Banalewicz, Judith L. Cruz, John W. Kitchens, Deborah Donohue, Mary Frey, Jennifer V. Helms, Jon M. Braverman, Dawn Alvarez, Mary B. Savell, Donna J. Chesbrough, Angella S. Karow, Adam R. Glassman, Garvin H. Davis, Brad C. Clifton, Paul A. Blais, Stacy Carpenter, Janis Graul, Pamela V. Singletary, Uma M. Balasubramaniam, S. Shah, Roy W. Beck, Sharon D. Solomon, Susan B. Bressler, Michele Melia, Craig N. Kelso, Michael J. Elman, William J. Wood, William J. Wirostko, Joe Fischer, Sandra Henriques, Steve Carlton, Jeffrey G. Gross, Rosemary C. Rhodes, Charisse Whitney, Janet Murphy, Paul G. Arrigg, Robert W. Cavicchi, Allen McKinney, Collin L. DuCoty, Robert H. Janigian, John M. Bourg, Dennis P. Han, Heather L. Murphy, Kenneth M. Huff, Damanda A. Fagan, Paul M. Beer, Terri Cain, Tracy A. Troszak, Linda M. Davis, David Emmert, Judy Flanders, Jeanne Van Arsdall, Michelle Buck, Brian A. Rusinek, Stephen T. Blevins, Kelly A. Blackmer, Timothy J. Murtha, Kimberly S. Walther, Joanne E. Bache, Leif S. Ryman, Sheila M. Rock, Alex L. Nagle, Margaret E. Stockman, Howard L. Cummings, Jolleen S. Key, Peter Sotirakos, Caldwell W. Smith, Helen K. Li, Sylvia Varadian, Jonathan Shankle, Loraine Clark, Michael D. McOwen, Jo Ann Starr, Melissa K. Cowen, Theresa M. Butcher, Giorya Shabi Andreani, Andrew N. Antoszyk, Dennis B. Backes, Donna McClain, Magdalena G. Krzystolik, Randall L. Price, K. M. Miller, Scott M. Friedman, Sasha I. Montalvo, Amber Crocker, Happy Spillar, Dawn M. Ryan, S. B. Bressler, L. Kaminski, Deanna Jo Long, George S. Sharuk, Nancy Gore, Jeanette Graf, Thomas W. Stone, Edward A. Slade, Christina T. Higdon, Manjot K. Gill, Teresa Coffey, Debbie M. Brown, Harold A. Woodcome, Lori E. Ackatz, Alice T. Lyon, Mark Hamel, Angela K. Price, Cecile Hunt, Antonio P. Ciardella, Laima M. O'Donnell, Jennifer K. Sun, Julie P. Berry, Joseph R. Beringer, Janelle Dane Zapata, Joseph M. Googe, Paul A. Edwards, Judy E. Kim, Deborah K. Schlossman, Sandra U. Castillo, Denise Garza, Karen Sjoblom, and Michelle D. Sloan

Subjects
Ophthalmology, medicine.medical_specialty, business.industry, Diabetic macular edema, Medicine, Observational study, business, Subclinical infection
Abstract

Correction to: Eye (2012) 26, 833–840; doi:10.1038/eye.2012.53; published online 23 March 2012 Since the publication of this article, the authors have noticed several errors that appeared in the online version of their paper. These errors have now been rectified, and the correct article appears in this issue.

Published
2012
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25. The drawstring temporary tarsorrhaphy technique

Author

Thomas A. Oetting, John Kinder, and John W. Kitchens

Subjects
Adult, Male, medicine.medical_specialty, genetic structures, Ophthalmologic Surgical Procedures, Polypropylenes, Corneal Diseases, medicine, Humans, Prolene, Aged, Wound Healing, Sutures, business.industry, Suture Techniques, Eyelids, corneal ulcer, medicine.disease, eye diseases, Surgery, Ophthalmology, medicine.anatomical_structure, Corneal epithelial defect, Tarsorrhaphy, sense organs, Eyelid, business, Ocular surface
Abstract

Tarsorrhaphy is used for the treatment of severe ocular surface disorders and cases of ocular exposure. Temporary tarsorrhaphy has been shown to aid in the healing of corneal epithelial defects. A variety of temporary techniques have been suggested that allow closure for epithelial healing but also allow access to the eye. The drawstring temporary tarsorrhaphy uses rubber bolsters and 6-0 prolene sutures passed through the eyelid margin. This modification of the temporary tarsorrhaphy allows for complete closure of the eyelids while providing easy opening and closing. In addition, this technique is easy to perform in almost any setting.

Published
2002

26. Choroidal Neovascularization After LASIK

Author

John W Kitchens, Minzhong Yu, Raj K Maturi, and Daniel H Spitzberg

Subjects
Male, medicine.medical_specialty, Photosensitizing Agents, business.industry, medicine.medical_treatment, Keratomileusis, Laser In Situ, Retinal Hemorrhage, LASIK, Keratomileusis, Choroidal Neovascularization, Ophthalmology, Choroidal neovascularization, Photochemotherapy, Myopia, medicine, Humans, Surgery, medicine.symptom, business
Published
2003
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27. Modified External Needle Drainage of Subretinal Fluid in the Management of Rhegmatogenous Retinal Detachment Using a 'Guarded Needle' Approach

Author

John W. Kitchens

Subjects
medicine.medical_specialty, Drainage procedure, business.industry, Subretinal Fluid, Retinal Detachment, Retinal detachment, medicine.disease, Retinal detachment surgery, Surgery, Scleral Buckling, Ophthalmology, Needles, medicine, Drainage, Humans, Subretinal fluid, business, Learning Curve
Abstract

External needle drainage of subretinal fluid is a useful technique to assist with retinal detachment surgery. This technique provides the ability to directly visualize the removal of subretinal fluid in a controlled manner. The major difficulty in learning this technique is the potential for overpenetration with the needle. Using a "guarded needle" approach can reduce this risk and increase the adoption of this useful method.

Published
2011
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28. Correspondence

Author

Darius M. Moshfeghi, Andrew A. Moshfeghi, Thomas A. Albini, Theodore Leng, and John W. Kitchens

Subjects
Pars plana, Ophthalmology, medicine.medical_specialty, medicine.anatomical_structure, business.industry, medicine.medical_treatment, medicine, Vitrectomy, General Medicine, business
Published
2011
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29. Increasing paintball related eye trauma reported to a state eye injury registry

Author

John W Kitchens and Ronald P. Danis

Subjects
Adult, Male, Indiana, Pediatrics, medicine.medical_specialty, Adolescent, genetic structures, Poison control, Eye protection, Occupational safety and health, Eye injuries, Eye Injuries, Injury prevention, medicine, Humans, Retrospective Studies, business.industry, Brief Report, Public Health, Environmental and Occupational Health, Retrospective cohort study, medicine.disease, humanities, eye diseases, Play and Playthings, body regions, Posterior segment of eyeball, Eye Protective Devices, sense organs, Medical emergency, business
Abstract

Objectives —To evaluate an apparent increase in documented trauma from paintball related eye injuries reported to the Eye Injury Registry of Indiana. Methods —A retrospective review of cases reported to the database is reported, with representative case histories. Results —No injuries from paintball were reported during the period June 1992 to June 1996. Over the next two years 11 injuries were reported, representing 4% of all ocular trauma reports over this period. Visual outcome is poor in many of these eyes and more than one half present with posterior segment ocular injury. Conclusions —Severe ocular trauma results from impacts from paintball pellets, and the occurrence of injuries appears to be increasing due to growth in popularity of this war game. Diligent use of eye protection by all participants is necessary to prevent a continuing rise in ocular trauma prevalence from this activity.

Published
1999
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31. Some Considerations on theRuralesof Porfirian Mexico

Author

John W. Kitchens

Subjects
Political science
Abstract

Las Fuerzas Rurales de la Federación, commonly called therurales, were a prominent institution of Porfirian Mexico and a significant instrument of the dictator's power. Contemporary travelers, journalists, and political propagandists either praised or condemned them and compared them to the Texas Rangers, the Royal Canadian Mounted Police, the SpanishGuardia Civil, Rosas’Mazorca, and even to Ivan the Terrible'sOprichniki.Almost all histories of Porfirian Mexico mention theruralesand indicate their significance to Diaz’ prolonged absolute control of the country. Without specific study and serious scholarship, however, the origin, nature, and exploits of theruraleshave acquired legendary characteristics. Because of their relative success in curbing brigandage on the one hand and their alleged brutality on the other, they became symbolic of both the order and the ruthlessness of Porfirian Mexico. The popular accounts of theruralesare easily divided into two categories—viz., those of Diaz’ apologists and those of his detractors. The following observation by Ethel Brilliana Tweedie is typical of the former.

Published
1967
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32. General Mosquera's Mission to Chile and Peru: A Turning Point in New Granadan Diplomacy

Author

John W. Kitchens

Subjects
Cultural Studies, History, media_common.quotation_subject, Political science, Economic history, Turning point, Diplomacy, media_common
Abstract

The 1842-1844 diplomatic mission of General Tomás Cipriano de Mosquera is generally assumed to have had as its major purpose the extradition of his personal and political enemy, General José María Obando. Obando had been a rebel leader in the War of the Supremos, the New Granadan civil war of 1839-1842, and the victorious administration in Bogotá (the ministeriales) had also charged him with complicity in the 1830 assassination of Marshal Antonio José de Sucre. During the diplomatic mission a large portion of Mosquera's time and effort was indeed spent in attempting to obtain Obando's extradition and to discredit him in various ways. This study, however, will be concerned primarily with the original objectives of the mission—those relating to New Granada's role in the regional diplomacy of western South America.

Published
1972
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