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1. Anterior Scleral Thickness and Anterior Segment Biometrics Measured with Swept Source Ocular Coherence Tomography in High Myopic Eyes with and without Glaucoma: A Comparative Study

Author

Bachar Kudsieh, Rocio Vega-González, Sofia Bryan, Elena Almazan-Alonso, Mariluz Puertas, Lucia Gutiérrez-Martin, Ignacio Flores-Moreno, Jorge Ruiz-Medrano, Muhsen Samaan, and Jose Maria Ruiz-Moreno

Subjects
high myopia, glaucoma, anterior scleral thickness, Schlemm’s canal, trabecular meshwork, conjunctival thickness, Medicine (General), R5-920
Abstract

Background: To assess the anterior scleral thickness (AST), Schlemm’s canal diameter (SCD), trabecular meshwork diameter (TMD) and conjunctiva tenon capsule thickness (CTT) in high myopic (HM) subjects and HM subjects with glaucoma (HMG) compared to control eyes. Methods: One hundred and twenty eyes were included, and AST at 0, 1, 2 and 3 mm from the scleral spur, SCD, TMD and CTT were measured. Results: Mean age was 64.2 ± 11.0 years, and the temporal SCD and temporal TMD were significantly longer in the HMG subjects compared to the controls (380.0 ± 62 μm vs. 316.7 ± 72 μm, p = 0.001) and (637.6 ± 113 μm vs. 512.1 ± 97 μm, p = 0.000), respectively. There were no significant differences between the HM and HMG subjects in SCD and TMD (all p > 0.025). Compared to the HM subjects, the temporal AST0 (432.5 ± 79 μm vs. 532.8 ± 99 μm, p = 0.000), temporal AST1 (383.9 ± 64 μm vs. 460.5 ± 80 μm, p = 0.000), temporal AST2 (404.0 ± 68 μm vs. 464.0 ± 88 μm, p = 0.006) and temporal AST3 (403.0 ± 80 μm vs. 458.1 ± 91 μm, p = 0.014) were significantly thinner in the HMG group. No differences were found between the CTT in the three groups (all p > 0.025). Conclusions: Our data indicate a thinner AST in HMG subjects and no differences in SCD and TMD between HM and HMG subjects.

Published
2024
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2. Choroidal Thickness in a Hyperopic Pediatric Population

Author

Vanessa Antonia Gerena Arévalo and Jose Maria Ruiz-Moreno

Subjects
hyperopia, swept-source optical coherence tomography, choroid, children, Medicine (General), R5-920
Abstract

Aims: To evaluate the choroidal thickness (CT) in hyperopic and emmetropic children using swept-source optical coherence tomography (SS-OCT). Methods: This was a prospective, cross-sectional comparative study. Macular choroidal thickness and axial length of 62 eyes from hyperopic pediatric patients were studied. CT was determined at nine different macular locations. The results were compared to 66 eyes of healthy pediatric patients. Results: Study groups were classified as a hyperopic group (SE ≥ 2D) and an emmetropic group (SE < 2D). The hyperopic group have shorter AL than the emmetropic group (p < 0.001). The mean CT is greater in the hyperopic group (p = 0.039), and there are no significant differences between CT and gender (p = 0.389). Study participants were also classified by age (2–5 years old and 6–18 years old), and we observe differences in CT, but these differences are only significant for the 6–18 years old group (p < 0.05). Conclusions: CT in hyperopic pediatric populations is statistically thicker than in healthy pediatric patients. AL and SE have statistically significant correlations with CT values, and those correlations are seen in children in the ocular slow-growing phase (6–18 years old), and not in the early years (2–5 years old).

Published
2022
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3. A Randomized Controlled Trial of OPT-302, a VEGF-C/D Inhibitor for Neovascular Age-Related Macular Degeneration

Author

Timothy L. Jackson, Jason Slakter, Marc Buyse, Kun Wang, Pravin U. Dugel, Charles C. Wykoff, David S. Boyer, Michael Gerometta, Megan E. Baldwin, Clare F. Price, Bohdan Kousal, Jan Studnicka, Michal Veith, Catherine Creuzot-Garcher, Flore De Bats, David Gaucher, Martine Mauget-Faysse, Eric Souied, Ramin Tadayoni, Andrea Facsko, Agnes Kerénvi, Andras Papp, Alexis Tsorbatzoglou, Gabor Vogt, Yoreh Barak, Itay Chowers, Michaella Goldstein, Joel Hanhart, Haya Morori-Katz, Irit Rosenblatt, Alexander Rubowitz, Oren Tomkins Netzer, Francesco Bandello, Antonio Ciardella, Federico Ricci, Giovanni Staurenghi, Gianni Virgili, Kristine Baumane, Guna Laganovska, Signe Ozolina, Ilze Strautmane, Bartlomiej Kaluzny, Jerzy Mackiewicz, Marta Misiuk-Hoilo, Ewa Mrukwa-Kominek, Piotr Oleksy, Krystyna Raczynska, Tomasz Zarnowski, Alfredo Adan, Javier Araiz, Anna Boixadera, Alvaro Fernández-Vega, Alfredo Garcia Layana, Francisco Gomez-Ulla, Javier Montero, Jose Maria Ruiz Moreno, David Gilmour, Timothy Jackson, Sidath Liyanage, Luke Membrey, Geeta Menon, Niro Narendran, Sobha Sivaprasad, Daniel Alfaro, Andrew Antoszyk, Carl Baker, Ivan Batille, Brian Berger, David Boyer, William Bridges, Harold Brooks, David Brown, Margaret Chang, Daniel Chao, Sanford Chen, Courtney Crawford, Pravin Dugel, Alexander Eaton, David Eichenbaum, Jordana Fein, Leonard Feiner, Christina Flaxel, Frank Garber, Alan Gordon, Sunil Gupta, Curtis Haegedorn, George Hampton, Thomas Hanscom, Vrinda Hershberger, Peter Kaiser, Randy Katz, Arshad Khanani, Erik Kruger, Denis Marcus, Matthew Ohr, Sunil Patel, Joel Pearlman, Richard Pesavento, Dante Pieramici, John Pitcher, Jay Prensky, John Randolf, Carl Regillo, Steven Rose, Michael Samuel, Todd Schneiderman, Sumit Shah, Michael Singer, Nathan Steinle, Glenn Stoller, Alan Thach, John Thompson, Michael Varenhorst, Alan Wagner, Joseph Walker, John Wells, Jonathan Williams, Robert Wong, and Charles Wykoff

Subjects
Ophthalmology
Published
2023
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4. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials

Author

Charles C Wykoff, Francis Abreu, Anthony P Adamis, Karen Basu, David A Eichenbaum, Zdenka Haskova, Hugh Lin, Anat Loewenstein, Shaun Mohan, Ian A Pearce, Taiji Sakamoto, Patricio G Schlottmann, David Silverman, Jennifer K Sun, John A Wells, Jeffrey R Willis, Ramin Tadayoni, Thomas Aaberg, Ashkan Abbey, Elmira Abdulaeva, Santiago Abengoechea, Prema Abraham, Thomas Ach, Serrhel Adams, Alfredo Adan Civera, Sean Adrean, Hansjurgen Agostini, Suhail Alam, Arturo Alezzandrini, Virgil Alfaro, Daniel Aliseda, Arghavan Almony, Pedro Amat, Payam Amini, Andrew Antoszyk, Luis Arias, Riaz Asaria, Marcos Avila, Carl C Awh, Joaquin Bafalluy, Carl Baker, Francesco Bandello, Mark Barakat, Karen Barraza, Gyorgy Bator, Caroline Baumal, Rubens Belfort Jr, Chris Bergstrom, George Bertolucci, Thomas Bochow, Matthias Bolz, Emilia Borcz, Arnaldo Bordon, David Boyer, Galina Bratko, Michael Brent, Jamin Brown, David M Brown, Maria Budzinskaya, Sylvia Buffet, Stuart Burgess, Ben Burton, Miguel Busquets, Francisco Cabrera, Carlo Cagini, Jorge Calzada, Peter Campochiaro, John Carlson, Alessandro Castellarin, Carlos Cava, Voraporn Chaikitmongkol, Clement Chan, Emmanuel Chang, Jonathan Chang, Andrew Chang, Steve Charles, Nauman Chaudhry, Caroline Chee, Judy Chen, Fred Chen, Shih-Jen Chen, Richard Cheong-Leen, Allen Chiang, Mark Chittum, David Chow, Brian Connolly, Pierre Loic Cornut, Karl Csaky, Carl Danzig, Arup Das, Vesselin Daskalov, Carmen Desco, Amr Dessouki, John Dickinson, Brian Do, Michael Dollin, Pravin Dugel, Jaroslava Dusova, David Eichenbaum, Bora Eldem, Robert Engstrom, Jan Ernest, Joan Josep Escobar, Simona Esposti, Nicole Eter, Naomi Falk, Andrej Farkas, Leonard Feiner, Nicolas Feltgen, Carlos Fernandez, Alvaro Fernandez Vega, Philip Ferrone, Joao Figueira, Marta Figueroa, Oliver Findl, Howard Fine, Jorge Fortun, Gregory M Fox, Scott Foxman, Carsten Framme, Samantha Fraser-Bell, Arthur Fu, Akira Fukutomi, Nicholas Fung, Federico Furno Sola, Roberto Gallego-Pinazo, Renata Garcia, Alfredo Garcia-Layana, Maciej Gawecki, Sheen George, Faruque Ghanchi, Ghassan Ghorayeb, Roger Goldberg, Michaella Goldstein, Nuno Gomes, Francisco Gomez Ulla, Victor Gonzalez, Craig Greven, Sunil Gupta, Miguel Guzman, Martin Harris, Katja Hatz, Vivienne Hau, Vincent Hau, Ken Hayashi, Jeffrey Heier, Ewa Herba, Vrinda Hershberger, Patrick Higgins, Akito Hirakata, Allen Ho, Nancy Holekamp, Shigeru Honda, Jason Hsu, Allen Hu, Maria Hurcikova, Yasuhiro Ikeda, Ricky Isernhagen, Yasuki Ito, Tim Jackson, Rachael Jacoby, Afsar Jafree, Golnaz Javey, Cameron Javid, Chirag Jhaveri, Mark Johnson, Marek Kacerík, Jakub Kaluzny, Daniel Kampik, Se Woong Kang, Kapil Kapoor, Levent Karabas, Tsutomu Kawasaki, Agnes Kerenyi, Arshad Khanani, Rahul Khurana, Brian Kim, Kazuhiro Kimura, Genichiro Kishino, Shigehiko Kitano, Kendra Klein-Mascia, Gregg Kokame, Jean Francois Korobelnik, Alexey Kulikov, Ajay Kuriyan, Henry Kwong, Robert Kwun, Timothy Lai, Chi-Chun Lai, Philip Laird, Laurent Lalonde, Paolo Lanzetta, Michael Larsen, Caroline Laugesen, Daniel Lavinsky, Olivier Lebreton, Seong Lee, Jaime Levy, Blandina Lipkova, Mimi Liu, Judy Liu, Chris P Lohmann, Nikolas London, Katrin Lorenz, Andrew Lotery, David Lozano Rechy, Silvio Lujan, Patrick Ma, Takatoshi Maeno, Sajjad Mahmood, Fuad Makkouk, Khurram Malik, Dennis Marcus, Alan Margherio, Leonardo Mastropasqua, Raj Maturi, Frank McCabe, Martin McKibbin, Hemal Mehta, Geeta Menon, Jale Mentes, Katarzyna Michalska-Malecka, Aneta Misheva, Yoshinori Mitamura, Paul Mitchell, Yasha Modi, Quresh Mohamed, Javier Montero, Jeffrey Moore, Virgilio Morales Canton, Haia Morori-Katz, Tatiana Morugova, Tomoaki Murakami, Maria Muzyka-Wozniak, Marco Nardi, Jan Nemcansky, Kamila Nester-Ostrowska, Julio Neto, Charles Newell, Massimo Nicolo, Jared Nielsen, Kousuke Noda, Akira Obana, Nahoko Ogata, Hideyasu Oh, Kean Oh, Matthew Ohr, Piotr Oleksy, Scott Oliver, Sebastien Olivier, James Osher, Sehnaz Ozcalişkan, Banu Ozturk, Andras Papp, Kyu Hyung Park, D Wilkin Parke, Maria Cristina Parravano, Sugat Patel, Sunil Patel, Ian Pearce, Joel Pearlman, Fernando Penha, Irfan Perente, Stephen Perkins, Grazia Pertile, Iva Petkova, Tunde Peto, Dante Pieramici, Andreas Pollreisz, Pear Pongsachareonnont, Nadezhda Pozdeyeva, Siegfried Priglinger, Jawad Qureshi, Dorota Raczynska, Rajesh Rajagopalan, Juan Ramirez Estudillo, Paul Raskauskas, Rajiv Rathod, Hessam Razavi, Carl Regillo, Federico Ricci, Soraya Rofagha, Dominika Romanczak, Bożena Romanowska-Dixon, Daniel Rosberger, Irit Rosenblatt, Brett Rosenblatt, Adam Ross, Paisan Ruamviboonsuk, Jose Maria Ruiz Moreno, Gustavo Salomão, Sukhpal Sandhu, Dirk Sandner, Laura Sararols, Osamu Sawada, Ramin Schadlu, Patricio Schlottmann, Claudia Schuart, Berthold Seitz, András Seres, Figen Sermet, Sandeep Shah, Ankur Shah, Rohan Shah, Sumit Sharma, Thomas Sheidow, Veeral Sheth, Akito Shimouchi, Masahiko Shimura, Bartosz Sikorski, Rufino Silva, Michael Singer, Lawrence Singerman, Rishi Singh, Eric Souied, David J Spinak, Georg Spital, Nathan Steinle, Jeffrey Stern, Glenn Stoller, Robert Stoltz, Cameron Stone, Amy Stone, Eric Suan, Masahiko Sugimoto, Iichiro Sugita, Jennifer Sun, Xiaodong Sun, Ivan Suner, Lajos Szalczer, Timea Szecsko, Ali Tabassian, Hitoshi Takagi, Kei Takayama, Alexandre Taleb, James Talks, Gavin Tan, Teruyo Tanabe, Stanford Taylor, Allen Thach, John Thompson, Paul Tlucek, Robert Torti, Daniela Tosheva Guneva, Edit Toth-Molnar, Eduardo Uchiyama, Attila Vajas, Deepali Varma, Balazs Varsanyi, Petja Vassileva, Sara Vaz-Pereira, Miroslav Veith, Jose Ignacio Vela, Francesco Viola, Gianni Virgili, Gábor Vogt, Henrik Vorum, Pamela Weber, Thoalf Wecke, Raymond Wee, Martin Weger, Paul Weishaar, Sanjeewa Wickremasinghe, Thomas Reginald Williams, Thomas Williams, Geoff Williams, Armin Wolf, Jeremy Wolfe, James Wong, David Wong, Ian Wong, Robert Wong, Bogumil Wowra, Edward Wylęgała, Chang-Hao Yang, Tsutomu Yasukawa, Paul Yates, Gursel Yilmaz, Glenn Yiu, Young Hee Yoon, Barak Yoreh, Shigeo Yoshida, Hyeong Gon Yu, Seung Young Yu, Tatiana Yurieva, Leandro Zacharias, Karolina Zaczek Zakrzewska, Alberto Zambrano, Barbara Zatorska, Carlos Zeolite, and Jeffrey Zheutlin

Subjects
Male, Vascular Endothelial Growth Factor A, Diabetic Retinopathy, Recombinant Fusion Proteins, Visual Acuity, Angiogenesis Inhibitors, General Medicine, Middle Aged, Drug Administration Schedule, Angiopoietin-2, Receptors, Vascular Endothelial Growth Factor, Treatment Outcome, Double-Blind Method, Antibodies, Bispecific, Intravitreal Injections, Edema, Humans, Female, Macula Lutea, Aged
Abstract

To reduce treatment burden and optimise patient outcomes in diabetic macular oedema, we present 1-year results from two phase 3 trials of faricimab, a novel angiopoietin-2 and vascular endothelial growth factor-A bispecific antibody.YOSEMITE and RHINE were randomised, double-masked, non-inferiority trials across 353 sites worldwide. Adults with vision loss due to centre-involving diabetic macular oedema were randomly assigned (1:1:1) to intravitreal faricimab 6·0 mg every 8 weeks, faricimab 6·0 mg per personalised treatment interval (PTI), or aflibercept 2·0 mg every 8 weeks up to week 100. PTI dosing intervals were extended, maintained, or reduced (every 4 weeks up to every 16 weeks) based on disease activity at active dosing visits. The primary endpoint was mean change in best-corrected visual acuity at 1 year, averaged over weeks 48, 52, and 56. Efficacy analyses included the intention-to-treat population (non-inferiority margin 4 Early Treatment Diabetic Retinopathy Study [ETDRS] letters); safety analyses included patients with at least one dose of study treatment. These trials are registered with ClinicalTrials.gov (YOSEMITE NCT03622580 and RHINE NCT03622593).3247 patients were screened for eligibility in YOSEMITE (n=1532) and RHINE (n=1715). After exclusions, 940 patients were enrolled into YOSEMITE between Sept 5, 2018, and Sept 19, 2019, and 951 patients were enrolled into RHINE between Oct 9, 2018, and Sept 20, 2019. These 1891 patients were randomly assigned to faricimab every 8 weeks (YOSEMITE n=315, RHINE n=317), faricimab PTI (n=313, n=319), or aflibercept every 8 weeks (n=312, n=315). Non-inferiority for the primary endpoint was achieved with faricimab every 8 weeks (adjusted mean vs aflibercept every 8 weeks in YOSEMITE 10·7 ETDRS letters [97·52% CI 9·4 to 12·0] vs 10·9 ETDRS letters [9·6 to 12·2], difference -0·2 ETDRS letters [-2·0 to 1·6]; RHINE 11·8 ETDRS letters [10·6 to 13·0] vs 10·3 ETDRS letters [9·1 to 11·4] letters, difference 1·5 ETDRS letters [-0·1 to 3·2]) and faricimab PTI (YOSEMITE 11·6 ETDRS letters [10·3 to 12·9], difference 0·7 ETDRS letters [-1·1 to 2·5]; RHINE 10·8 ETDRS letters [9·6 to 11·9], difference 0·5 ETDRS letters [-1·1 to 2·1]). Incidence of ocular adverse events was comparable between faricimab every 8 weeks (YOSEMITE n=98 [31%], RHINE n=137 [43%]), faricimab PTI (n=106 [34%], n=119 [37%]), and aflibercept every 8 weeks (n=102 [33%], n=113 [36%]).Robust vision gains and anatomical improvements with faricimab were achieved with adjustable dosing up to every 16 weeks, demonstrating the potential for faricimab to extend the durability of treatment for patients with diabetic macular oedema.F Hoffmann-La Roche.

Published
2022
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5. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials

Author

Jeffrey S Heier, Arshad M Khanani, Carlos Quezada Ruiz, Karen Basu, Philip J Ferrone, Christopher Brittain, Marta S Figueroa, Hugh Lin, Frank G Holz, Vaibhavi Patel, Timothy Y Y Lai, David Silverman, Carl Regillo, Balakumar Swaminathan, Francesco Viola, Chui Ming Gemmy Cheung, Tien Y Wong, Ashkan Abbey, Elmira Abdulaeva, Prema Abraham, Alfredo Adan Civera, Hansjurgen Agostini, Arturo Alezzandrini, Virgil Alfaro, Arghavan Almony, Lebriz Altay, Payam Amini, Andrew Antoszyk, Etelka Aradi, Luis Arias, Jennifer Arnold, Riaz Asaria, Sergei Astakhov, Yury Astakhov, Carl C. Awh, Chandra Balaratnasingam, Sanjiv Banerjee, Caroline Baumal, Matthias Becker, Rubens Belfort, Galina Bratko, William Jr. Z Bridges, Jamin Brown, David M. Brown, Maria Budzinskaya, Sylvia Buffet, Stuart Burgess, Iksoo Byon, Carlo Cagini, Jorge Calzada, Stone Cameron, Peter Campochiaro, John Carlson, Angela Carneiro, Clement Chan, Emmanuel Chang, Andrew Chang, Daniel Chao, Nauman Chaudhry, Caroline Chee, Andrew Cheek, Shih-Jen Chen, San-Ni Chen, Gemmy Cheung, Saradha Chexal, Mark Chittum, David Chow, Abosede Cole, Brian Connolly, Pierre Loic Cornut, Stephen Couvillion, Carl Danzig, Vesselin Daskalov, Amr Dessouki, Francois Devin, Michael Dollin, Rosa Dolz, Louise Downey, Richard Dreyer, Pravin Dugel, David Eichenbaum, Bora Eldem, Robert Engstrom, Joan Josep Escobar, Nicole Eter, David W. Faber, Naomi Falk, Leonard Feiner, Alvaro Fernandez Vega, Philip Ferrone, Marta Figueroa, Howard Fine, Mitchell Fineman, Gregory M. Fox, Catherine Francais, Pablo Franco, Samantha Fraser-Bell, Nicholas Fung, Federico Furno Sola, Richard Gale, Alfredo Garcia-Layana, Julie Gasperini, Maciej Gawecki, Faruque Ghanchi, Manjot Gill, Michel Giunta, David Glaser, Michaella Goldstein, Francisco Gomez Ulla, Fumi Gomi, Victor Gonzalez, Jordan Graff, Sunil Gupta, Rainer Guthoff, Robyn Guymer, Anton Haas, Robert Hampton, Katja Hatz, Ken Hayashi, Jeffrey Heier, Ewa Herba, Vrinda Hershberger, Patrick Higgins, Nancy Holekamp, Shigeru Honda, James Howard, Allen Hu, Stephen Huddleston, Tomohiro Iida, Hiroko Imaizumi, Yasuo Ito, Yasuki Ito, Sujit Itty, Golnaz Javey, Cameron Javid, Tatsushi Kaga, Jakub Kaluzny, Se Woong Kang, Kapil Kapoor, Levent Karabas, Tsutomu Kawasaki, Patrick Kelty, Agnes Kerenyi, Arshad Khanani, Ramin Khoramnia, Rahul Khurana, Kazuhiro Kimura, Kendra Klein-Mascia, Namie Kobayashi, Laurent Kodjikian, Hideki Koizumi, Gregg Kokame, Alexey Kulikov, Henry Kwong, Robert Kwun, Timothy Lai, Chi-Chun Lai, Laurent Lalonde, Paolo Lanzetta, Michael Larsen, Adrian Lavina, Won Ki Lee, ji Eun Lee, Seong Lee, Jaime Levy, Lucas Lindsell, Mimi Liu, Nikolas London, Andrew Lotery, David Lozano Rechy, Alan Luckie, David Maberley, Takatoshi Maeno, Sajjad Mahmood, Fuad Makkouk, Dennis Marcus, Alan Margherio, Helene Masse, Hisashi Matsubara, Raj Maturi, Sonia Mehta, Geeta Menon, Jale Mentes, Mark Michels, Yoshinori Mitamura, Paul Mitchell, Quresh Mohamed, Jordi Mones, Rodrigo Montemayor Lobo, Javier Montero, Jeffrey Moore, Ryusaburo Mori, Haia Morori-Katz, Raj Mukherjee, Toshinori Murata, Maria Muzyka-Wozniak, Marco Nardi, Niro Narendran, Massimo Nicolo, Jared Nielsen, Tetsuya Nishimura, Kousuke Noda, Anna Nowinska, Hideyasu Oh, Matthew Ohr, Annabelle Okada, Piotr Oleksy, Shinji Ono, Sengul Ozdek, Banu Ozturk, Luis Pablo, Kyu Hyung Park, D. Wilki Parke, Maria Cristina Parravano, Praveen Patel, Apurva Patel, Sunil Patel, Sugat Patel, Daniel Pauleikhoff, Ian Pearce, Joel Pearlman, Iva Petkova, Dante Pieramici, Nadezhda Pozdeyeva, Jawad Qureshi, Dorota Raczynska, Juan Ramirez Estudillo, Rajiv Rathod, Hessam Razavi, Gayatri Reilly, Federico Ricci, Ryan Rich, Bożena Romanowska-Dixon, Irit Rosenblatt, Jose Maria Ruiz Moreno, Stefan Sacu, Habiba Saedon, Usman Saeed, Min Sagong, Taiji Sakamoto, Sukhpal Sandhu, Laura Sararols, Mario Saravia, Ramin Schadlu, Patricio Schlottmann, Tetsuju Sekiryu, András Seres, Figen Sermet, Sumit Shah, Rohan Shah, Ankur Shah, Thomas Sheidow, Veeral Sheth, Chieko Shiragami, Bartosz Sikorski, Rufino Silva, Lawrence Singerman, Robert Sisk, Torben L. Sørensen, Eric Souied, David-J Spinak, Giovanni Staurenghi, Robert Steinmetz, Glenn Stoller, Robert Stoltz, Eric Suan, Ivan Suner, Yzer Suzanne, Ramin Tadayoni, Kanji Takahashi, Kei Takayama, Alexandre Taleb, James Talks, Hiroko Terasaki, John Thompson, Edit Toth-Molnar, Khoi Tran, Raman Tuli, Eduardo Uchiyama, Attila Vajas, Janneke Van Lith-Verhoeven, Balazs Varsanyi, Gianni Virgili, Gábor Vogt, Michael Völker, David Warrow, Pamela Weber, John A. Wells, Sanjeewa Wickremasinghe, Mark Wieland, Geoff Williams, Thomas Williams, David Wong, King Wong, James Wong, Ian Wong, Robert Wong, Bogumil Wowra, Charles C. Wykoff, Ayana Yamashita, Kanako Yasuda, Gursel Yilmaz, Glenn Yiu, Ai Yoneda, Young Hee Yoon, Barak Yoreh, HyeongGon Yu, Seung Young Yu, Tatiana Yurieva, Alberto Zambrano, Barbara Zatorska, and Carlos Zeolite

Subjects
Aged, 80 and over, Male, Vascular Endothelial Growth Factor A, Recombinant Fusion Proteins, Visual Acuity, Angiogenesis Inhibitors, General Medicine, Drug Administration Schedule, Angiopoietin-2, Macular Degeneration, Receptors, Vascular Endothelial Growth Factor, Treatment Outcome, Double-Blind Method, Antibodies, Bispecific, Intravitreal Injections, Humans, Female, Aged
Abstract

Faricimab is a bispecific antibody that acts through dual inhibition of both angiopoietin-2 and vascular endothelial growth factor A. We report primary results of two phase 3 trials evaluating intravitreal faricimab with extension up to every 16 weeks for neovascular age-related macular degeneration (nAMD).TENAYA and LUCERNE were randomised, double-masked, non-inferiority trials across 271 sites worldwide. Treatment-naive patients with nAMD aged 50 years or older were randomly assigned (1:1) to intravitreal faricimab 6·0 mg up to every 16 weeks, based on protocol-defined disease activity assessments at weeks 20 and 24, or aflibercept 2·0 mg every 8 weeks. Randomisation was performed through an interactive voice or web-based response system using a stratified permuted block randomisation method. Patients, investigators, those assessing outcomes, and the funder were masked to group assignments. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44, and 48 (prespecified non-inferiority margin of four letters), in the intention-to-treat population. Safety analyses included patients who received at least one dose of study treatment. These trials are registered with ClinicalTrials.gov (TENAYA NCT03823287 and LUCERNE NCT03823300).Across the two trials, 1329 patients were randomly assigned between Feb 19 and Nov 19, 2019 (TENAYA n=334 faricimab and n=337 aflibercept), and between March 11 and Nov 1, 2019 (LUCERNE n=331 faricimab and n=327 aflibercept). BCVA change from baseline with faricimab was non-inferior to aflibercept in both TENAYA (adjusted mean change 5·8 letters [95% CI 4·6 to 7·1] and 5·1 letters [3·9 to 6·4]; treatment difference 0·7 letters [-1·1 to 2·5]) and LUCERNE (6·6 letters [5·3 to 7·8] and 6·6 letters [5·3 to 7·8]; treatment difference 0·0 letters [-1·7 to 1·8]). Rates of ocular adverse events were comparable between faricimab and aflibercept (TENAYA n=121 [36·3%] vs n=128 [38·1%], and LUCERNE n=133 [40·2%] vs n=118 [36·2%]).Visual benefits with faricimab given at up to 16-week intervals demonstrates its potential to meaningfully extend the time between treatments with sustained efficacy, thereby reducing treatment burden in patients with nAMD.F Hoffmann-La Roche.

Published
2022
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6. Multimodal Imaging-Based Central Serous Chorioretinopathy Classification

Author

Jay Chhablani, Francine Behar Cohen, Pauline Aymard, Talal Beydoun, Elodie Bousquet, Alejandra Daruich-Matet, Alexandre Matet, Min Zhao, Chui Ming Gemmy Cheung, K. Bailey Freund, Richard Spaide, Alain Gaudric, Camiel J.F. Boon, E.H.C. van Dijk, Andrew Lotery, Marco Lupidi, Irmela Mantel, Thibaud Mathis, Martine Mauget-Faysse, Sarah Mrejen, Giuseppe Querques, Jorge Ruiz-Medrano, Jose-Maria Ruiz-Moreno, Shiri Shulman, Sumit Randhir Singh, Sobha Sivaprasad, Suzanne Yzer, Sandrine Zweifel, and ANS - Complex Trait Genetics

Subjects
Multimodal imaging, medicine.medical_specialty, Fundus Oculi, business.industry, MEDLINE, Multimodal Imaging, Sensory disorders Donders Center for Medical Neuroscience [Radboudumc 12], Ophthalmology, Serous fluid, Text mining, Central Serous Chorioretinopathy, Humans, Medicine, Medical physics, Fluorescein Angiography, business, Tomography, Optical Coherence
Abstract

Item does not contain fulltext

Published
2020

7. Update on the Utility of Optical Coherence Tomography in the Analysis of the Optic Nerve Head in Highly Myopic Eyes with and without Glaucoma

Author

Bachar Kudsieh, José Ignacio Fernández-Vigo, Ignacio Flores-Moreno, Jorge Ruiz-Medrano, Maria Garcia-Zamora, Muhsen Samaan, and Jose Maria Ruiz-Moreno

Subjects
General Medicine
Abstract

Glaucoma diagnosis in highly myopic subjects by optic nerve head (ONH) imaging is challenging as it is difficult to distinguish structural defects related to glaucoma from myopia-related defects in these subjects. Optical coherence tomography (OCT) has evolved to become a routine examination at present, providing key information in the assessment of glaucoma based on the study of the ONH. However, the correct segmentation and interpretation of the ONH data employing OCT is still a challenge in highly myopic patients. High-resolution OCT images can help qualitatively and quantitatively describe the structural characteristics and anatomical changes in highly myopic subjects with and without glaucoma. The ONH and peripapillary area can be analyzed to measure the myopic atrophic-related zone, the existence of intrachoroidal cavitation, staphyloma, and ONH pits by OCT. Similarly, the lamina cribosa observed in the OCT images may reveal anatomical changes that justify visual defects. Several quantitative parameters of the ONH obtained from OCT images were proposed to predict the progression of visual defects in glaucoma subjects. Additionally, OCT images help identify factors that may negatively influence the measurement of the retinal nerve fiber layer (RNFL) and provide better analysis using new parameters, such as Bruch’s Membrane Opening-Minimum Rim Width, which serves as an alternative to RNFL measurements in highly myopic subjects due to its superior diagnostic ability.

Published
2023
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8. Updates on the utility of anterior segment optical coherence tomography in the assessment of filtration blebs after glaucoma surgery

Author

Javier Aritz Urcola, José Ignacio Fernández-Vigo, José Ángel Fernández-Vigo, Jose Maria Ruiz Moreno, Jorge Vila-Arteaga, Julian Garcia-Feijoo, Maria Isabel Canut Jordana, and Bachar Kudsieh

Subjects
Intraocular pressure, medicine.medical_specialty, genetic structures, Minimally invasive glaucoma surgery, medicine.medical_treatment, Glaucoma, Trabeculectomy, Postoperative Complications, Suture (anatomy), Optical coherence tomography, Anterior Eye Segment, Ophthalmology, medicine, Glaucoma surgery, Humans, Bleb (cell biology), Glaucoma Drainage Implants, Intraocular Pressure, medicine.diagnostic_test, business.industry, General Medicine, medicine.disease, eye diseases, surgical procedures, operative, sense organs, business, Tomography, Optical Coherence
Abstract

The formation of filtration blebs is the main drainage mechanism for reducing intraocular pressure after traditional incisional glaucoma surgery such as trabeculectomy and non-penetrating deep sclerotomy. Early and short-lasting blebs may also occur after canaloplasty. Bleb formation also plays an important role after the implantation of glaucoma drainage devices, including Minimally Invasive Glaucoma Surgery devices. Anterior segment optical coherence tomography (AS-OCT) is a rapid and non-invasive high-resolution imaging technique that has evolved in recent years to become a routine examination. Anterior segment optical coherence tomography (AS-OCT) provides key information in the assessment and follow-up of glaucoma surgery, especially in the assessment of filtration blebs. Thus, bleb morphology can be qualitatively classified into diffuse, cystic, encapsulated and flattened, and AS-OCT imaging can also provide several quantitative parameters of the bleb, such as total bleb height, bleb fluid-filled cavity height, bleb wall thickness, number of microcysts and trabeculectomy opening size. These parameters could have an impact on clinical management during follow-up because they may predict the success or failure of the surgery in the early and late postoperative periods. Additionally, they may also guide the procedures used to increase filtration and reduce intraocular pressure, such as bleb needling and laser suture lysis.

Published
2021
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9. Three-Year, Randomized, Sham-Controlled Trial of Dexamethasone Intravitreal Implant in Patients with Diabetic Macular Edema

Author

David S. Boyer, 1 Young Hee Yoon, MD, PhD, 2 Rubens Belfort, Jr, MD, PhD, 3 Francesco Bandello, 4 Raj K. Maturi, 5 Albert J. Augustin, 6 Xiao Yan Li, 7 Harry Cui, 7 Yehia Hashad, 7 Scott M. Whitcup, MDThe MEAD Study Group Principal Investigators: Suel Abujamra, James Acton, Fareed Ali, Andrew Antoszyk, Albert J. Augustin, Carl C. Awh, Adiel Barak, Karl Ulrich Bartz Schmidt, Caroline R. Baumal, Rubens Belfort, J.r., Muna Bhende, William Z. Bridges, David M. Brown, Trevor Carmichael, Ken Carnevale, Antonio M. Casella, Tom Chang, Daniel Chechik, San Ni Chen, Lawrence P. Chong, Victor Chong, Joel Corwin, Catherine Creuzot Garcher, Alan Cruess, Mark Daniell, Marcos P. de Avila, Haroldo Vieira de Moraes, Robert G. Devenyi, Bernard H. Doft, Mark Donaldson, Richard Dreyer, Dean Eliott, Harry M. Engel, Jan Ernest, Thomas F. Essman, Philip M. Falcone, Sharon Fekrat, Joseph R. Ferencz, Joao L. Ferreira, Joao Figueira, Ivan Fiser, Bradley Foster, Gregory M. Fox, William R. Freeman, S. P. Garg, Mark Gillies, David Glaser, Burton G. Goldstein, Andre M. V. Gomes, John R. Gonder, Lingam Gopal, Petrus Gous, Amod Gupta, Anurag Gupta, Lawrence Halperin, Dennis Han, Seenu M. Hariprasad, Frank G. Holz, Peter Kaiser, Bohdana Kalvodova, Barrett Katz, Randy S. Katz, Dariusz Kecik, Judianne Kellaway, Itamar Klemperer, Baruch Kuppermann, Paolo Lanzetta, Rosangela Lattanzio, Won Ki Lee, John Lehr, Monique Leys, Isaac Loose, Andrew Lotery, Da Wen Lu, Paul McCartney, Ajit B. Majji, Jose A. Martinez, Pascale Massin, Raj K. Maturi, Ugo Menchini, Geeta Menon, Mark Michels, Edoardo Midena, James Miller, Paul Mitchell, Joseph Moisseiev, Lawrence Morse, Rafael Navarro, Janos Nemeth, Henry Newland, Richard Newsom, John Nichols, Juan Orellana, Nicola Orzalesi, Augusto Paranhos, Robert Park, Susanna Park, Maurizio Battaglia Parodi, Peter R. Pavan, James Peace, Don J. Perez Ortiz, Ayala Pollack, Kim Ramaswamy, Ramakrishna Ratnakaram, Giuseppe Ravalico, Jiri Rehak, Kourous Rezaei, Stanislao Rizzo, Francisco J. Rodriguez Alvira, Jean Paul Romanet, Steven Rose, Richard B. Rosen, Luca Rossetti, Jose Maria Ruiz Moreno, SriniVas Sadda, Kenneth Sall, Dirk Sandner, Alvaro Fernandez Vega Sanz, Gil Sartani, Stefanie Schmickler, Steven D. Schwartz, Y. R. Sharma, Shwu Jiuan Sheu, Michael Singer, Sobha Sivaprasad, Gisele Soubrane, Petr Soucek, Eric H. Souied, Giovanni Staurenghi, Jan Studnicka, Marta Suarez Figueroa, Walter Y. Takahashi, Patrick L. Tsai, Lawrence J. Ulanski, Harvey Uy, Monica Varano, Miroslav Veith, Igor Vicha, Francesco Viola, Linda Visser, Dov Weinberger, Glenn L. Wing, Edmund Wong, Tien Wong, Edward Wylegala, Jiong Yan, Young Hee Yoon, Lucy H. Young, Hyeong G. Yu, Ingrid E. Zimmer Galler, TOGNETTO, DANIELE, Boyer, D, Yoon, Yh, Belfort, R, Bandello, Francesco, Maturi, Rk, Augustin, Aj, Li, Xy, Cui, H, Hashad, Y, Whitcup, Sm, David S., Boyer, Md, 1 Young Hee, Yoon, Md, Phd, 2 Rubens, Belfort, Jr, Md, Phd, 3 Francesco, Bandello, 4 Raj K., Maturi, 5 Albert J., Augustin, 6 Xiao Yan, Li, 7 Harry, Cui, Ms, 7 Yehia, Hashad, 7 Scott M., Whitcup, MDThe MEAD Study Group Principal Investigators: Suel, Abujamra, James, Acton, Fareed, Ali, Andrew, Antoszyk, Albert J., Augustin, Carl C., Awh, Adiel, Barak, Karl Ulrich Bartz, Schmidt, Caroline R., Baumal, Rubens, Belfort, J., R., Muna, Bhende, William Z., Bridge, David M., Brown, Trevor, Carmichael, Ken, Carnevale, Antonio M., Casella, Tom, Chang, Daniel, Chechik, San Ni, Chen, Lawrence P., Chong, Victor, Chong, Joel, Corwin, Catherine Creuzot, Garcher, Alan, Crue, Mark, Daniell, Marcos P., de Avila, Haroldo Vieira de, Morae, Robert G., Devenyi, Bernard H., Doft, Mark, Donaldson, Richard, Dreyer, Dean, Eliott, Harry M., Engel, Jan, Ernest, Thomas F., Essman, Philip M., Falcone, Sharon, Fekrat, Joseph R., Ferencz, Joao L., Ferreira, Joao, Figueira, Ivan, Fiser, Bradley, Foster, Gregory M., Fox, William R., Freeman, S. P., Garg, Mark, Gillie, David, Glaser, Burton G., Goldstein, Andre M. V., Gome, John R., Gonder, Lingam, Gopal, Petrus, Gou, Amod, Gupta, Anurag, Gupta, Lawrence, Halperin, Dennis, Han, Seenu M., Hariprasad, Frank G., Holz, Peter, Kaiser, Bohdana, Kalvodova, Barrett, Katz, Randy S., Katz, Dariusz, Kecik, Judianne, Kellaway, Itamar, Klemperer, Baruch, Kuppermann, Paolo, Lanzetta, Rosangela, Lattanzio, Won Ki, Lee, John, Lehr, Monique, Ley, Isaac, Loose, Andrew, Lotery, Da Wen, Lu, Paul, Mccartney, Ajit B., Majji, Jose A., Martinez, Pascale, Massin, Raj K., Maturi, Ugo, Menchini, Geeta, Menon, Mark, Michel, Edoardo, Midena, James, Miller, Paul, Mitchell, Joseph, Moisseiev, Lawrence, Morse, Rafael, Navarro, Janos, Nemeth, Henry, Newland, Richard, Newsom, John, Nichol, Juan, Orellana, Nicola, Orzalesi, Augusto, Paranho, Robert, Park, Susanna, Park, Maurizio Battaglia, Parodi, Peter R., Pavan, James, Peace, Don J., Perez Ortiz, Ayala, Pollack, Kim, Ramaswamy, Ramakrishna, Ratnakaram, Giuseppe, Ravalico, Jiri, Rehak, Kourous, Rezaei, Stanislao, Rizzo, Francisco J., Rodriguez Alvira, Jean Paul, Romanet, Steven, Rose, Richard B., Rosen, Luca, Rossetti, Jose Maria Ruiz, Moreno, Srinivas, Sadda, Kenneth, Sall, Dirk, Sandner, Alvaro Fernandez Vega, Sanz, Gil, Sartani, Stefanie, Schmickler, Steven D., Schwartz, Y. R., Sharma, Shwu Jiuan, Sheu, Michael, Singer, Sobha, Sivaprasad, Gisele, Soubrane, Petr, Soucek, Eric H., Souied, Giovanni, Staurenghi, Jan, Studnicka, Marta Suarez, Figueroa, Walter Y., Takahashi, Tognetto, Daniele, Patrick L., Tsai, Lawrence J., Ulanski, Ii, Harvey, Uy, Monica, Varano, Miroslav, Veith, Igor, Vicha, Francesco, Viola, Linda, Visser, Dov, Weinberger, Glenn L., Wing, Edmund, Wong, Tien, Wong, Edward, Wylegala, Jiong, Yan, Young Hee, Yoon, Lucy H., Young, Hyeong G., Yu, and Ingrid E., Zimmer Galler

Subjects
Adult, Male, Intraocular pressure, Triamcinolone acetonide, Visual acuity, genetic structures, Anti-Inflammatory Agents, Visual Acuity, Phases of clinical research, Dexamethasone, Macular Edema, law.invention, Randomized controlled trial, law, Health Sciences, Dexamethasone Intravitreal Implant (Ozurdex, Dexamethasone Intravitreal Implant, Humans, Medicine, Aged, Aged, 80 and over, Drug Implants, Diabetic Retinopathy, business.industry, Area under the curve, Middle Aged, Ophthalmology, DEX implant Diabetic Macular Edemat, Area Under Curve, Anesthesia, Intravitreal Injections, Dexamethasone Intravitreal Implant (Ozurdex, DEX implant Diabetic Macular Edemat, Female, Implant, medicine.symptom, business, hormones, hormone substitutes, and hormone antagonists, medicine.drug
Abstract

Purpose: To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex, DEX implant) 0.7 and 0.35 mg in the treatment of patients with diabetic macular edema (DME).Design: Two randomized, multicenter, masked, sham-controlled, phase III clinical trials with identical protocols were conducted. Data were pooled for analysis.Participants: Patients (n = 1048) with DME, best-corrected visual acuity (BCVA) of 20/50 to 20/200 Snellen equivalent, and central retinal thickness (CRT) of ≥300 μm by optical coherence tomography.Methods: Patients were randomized in a 1:1:1 ratio to study treatment with DEX implant 0.7 mg, DEX implant 0.35 mg, or sham procedure and followed for 3 years (or 39 months for patients treated at month 36) at ≤40 scheduled visits. Patients who met retreatment eligibility criteria could be retreated no more often than every 6 months.Main Outcome Measures: The predefined primary efficacy endpoint for the United States Food and Drug Administration was achievement of ≥15-letter improvement in BCVA from baseline at study end. Safety measures included adverse events and intraocular pressure (IOP).Results: Mean number of treatments received over 3 years was 4.1, 4.4, and 3.3 with DEX implant 0.7 mg, DEX implant 0.35 mg, and sham, respectively. The percentage of patients with ≥15-letter improvement in BCVA from baseline at study end was greater with DEX implant 0.7 mg (22.2%) and DEX implant 0.35 mg (18.4%) than sham (12.0%; P ≤ 0.018). Mean average reduction in CRT from baseline was greater with DEX implant 0.7 mg (−111.6 μm) and DEX implant 0.35 mg (−107.9 μm) than sham (−41.9 μm; P < 0.001). Rates of cataract-related adverse events in phakic eyes were 67.9%, 64.1%, and 20.4% in the DEX implant 0.7 mg, DEX implant 0.35 mg, and sham groups, respectively. Increases in IOP were usually controlled with medication or no therapy; only 2 patients (0.6%) in the DEX implant 0.7 mg group and 1 (0.3%) in the DEX implant 0.35 mg group required trabeculectomy.Conclusions: The DEX implant 0.7 mg and 0.35 mg met the primary efficacy endpoint for improvement in BCVA. The safety profile was acceptable and consistent with previous reports.

Published
2014
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