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1. Endpoints and Design for Clinical Trials in USH2A-Related Retinal Degeneration: Results and Recommendations From the RUSH2A Natural History Study

Author

Maguire, Maureen G, Birch, David G, Duncan, Jacque L, Ayala, Allison R, Ayton, Lauren N, Cheetham, Janet K, Cheng, Peiyao, Durham, Todd A, Ferris, Frederick L, Hoyng, Carel B, Huckfeldt, Rachel M, Jaffe, Glenn J, Kay, Christine, Lad, Eleonora M, Leroy, Bart P, Liang, Wendi, McDaniel, Lee S, Melia, Michele, Michaelides, Michel, Pennesi, Mark E, Sahel, José-Alain, Samarakoon, Lassana, and Group, on behalf of the REDI Working Group and the Foundation Fighting Blindness Clinical Consortium Investigator

Subjects
Biomedical and Clinical Sciences, Ophthalmology and Optometry, Clinical Research, Clinical Trials and Supportive Activities, Neurodegenerative, Neurosciences, Eye Disease and Disorders of Vision, Eye, Humans, Visual Acuity, Visual Fields, Visual Field Tests, Extracellular Matrix Proteins, Female, Male, Adult, Retinal Degeneration, Middle Aged, Tomography, Optical Coherence, Clinical Trials as Topic, Young Adult, Aged, Research Design, Adolescent, Usher Syndromes, retinal degeneration, epidemiology, clinical trials, REDI Working Group and the Foundation Fighting Blindness Clinical Consortium Investigator Group, Biomedical Engineering, Opthalmology and Optometry, Ophthalmology and optometry
Abstract

PurposeTo evaluate functional and structural assessments as endpoints for clinical trials for USH2A-related retinal degeneration.MethodsPeople with biallelic disease-causing variants in USH2A, visual acuity ≥ 20/80, and visual field ≥ 10° diameter were enrolled in a 4-year, natural history study. Participants underwent static perimetry, microperimetry, visual acuity, fullfield stimulus testing (FST), and optical coherence tomography annually. Rates of change estimated from mixed-effects linear models and percentages of eyes with changes exceeding the coefficient of repeatability (CoR) or thresholds conforming with U.S. Food and Drug Administration (FDA) guidelines were evaluated.ResultsRates of change were generally more sensitive to change than proportions of eyes exceeding a threshold such as the CoR. Baseline ellipsoid zone area ≥ 3 mm2 was necessary to detect change. Mean sensitivity and volumetric hill of vision measures on static perimetry had similar properties and were the most sensitive to changes of the continuous measures. The highest 4-year proportions of eyes exceeding the CoR were from FST testing (47%) and microperimetry (32%). Specification of loci as functional transition points (FTPs) resulted in 45% (static perimetry) and 46% (microperimetry) at 4 years, meeting FDA guidelines for progression.ConclusionsRate of change of mean sensitivity on static perimetry was a sensitive perimetric continuous measure. Percentages of within-eye change were largest with FST testing and microperimetry. FTPs appear to be particularly sensitive to change. These results affect clinical trial design for USH2A-related retinal degeneration.Translational relevanceAnalyses of natural history data from the Rate of Progression in USH2A-Related Retinal Degeneration (RUSH2A) study can inform eligibility criteria and endpoints for clinical trials.

Published
2024

2. Baseline Microperimetry and OCT in the RUSH2A Study: Structure−Function Association and Correlation With Disease Severity

Author

Lad, Eleonora M, Duncan, Jacque L, Liang, Wendi, Maguire, Maureen G, Ayala, Allison R, Audo, Isabelle, Birch, David G, Carroll, Joseph, Cheetham, Janet K, Durham, Todd A, Fahim, Abigail T, Loo, Jessica, Deng, Zengtian, Mukherjee, Dibyendu, Heon, Elise, Hufnagel, Robert B, Guan, Bin, Iannaccone, Alessandro, Jaffe, Glenn J, Kay, Christine N, Michaelides, Michel, Pennesi, Mark E, Vincent, Ajoy, Weng, Christina Y, and Farsiu, Sina

Subjects
Biomedical and Clinical Sciences, Ophthalmology and Optometry, Eye Disease and Disorders of Vision, Neurosciences, Biomedical Imaging, Usher Syndrome, Rare Diseases, Neurodegenerative, Clinical Research, Eye, Humans, Usher Syndromes, Visual Field Tests, Tomography, Optical Coherence, Visual Acuity, Retinal Degeneration, Severity of Illness Index, Foundation Fighting Blindness Consortium Investigator Group, Clinical Sciences, Opthalmology and Optometry, Public Health and Health Services, Ophthalmology & Optometry, Ophthalmology and optometry
Abstract

PurposeTo investigate baseline mesopic microperimetry (MP) and spectral domain optical coherence tomography (OCT) in the Rate of Progression in USH2A-related Retinal Degeneration (RUSH2A) study.DesignNatural history study METHODS: Setting: 16 clinical sites in Europe and North AmericaStudy Population: Participants with Usher syndrome type 2 (USH2) (N = 80) or autosomal recessive nonsyndromic RP (ARRP) (N = 47) associated with biallelic disease-causing sequence variants in USH2AObservation Procedures: General linear models were used to assess characteristics including disease duration, MP mean sensitivity and OCT intact ellipsoid zone (EZ) area. The associations between mean sensitivity and EZ area with other measures, including best corrected visual acuity (BCVA) and central subfield thickness (CST) within the central 1 mm, were assessed using Spearman correlation coefficients.Main outcome measuresMean sensitivity on MP; EZ area and CST on OCT.ResultsAll participants (N = 127) had OCT, while MP was obtained at selected sites (N = 93). Participants with Usher syndrome type 2 (USH2, N = 80) and nonsyndromic autosomal recessive Retinitis Pigmentosa (ARRP, N = 47) had the following similar measurements: EZ area (median (interquartile range [IQR]): 1.4 (0.4, 3.1) mm2 vs 2.3 (0.7, 5.7) mm2) and CST (median (IQR): 247 (223, 280) µm vs 261 (246, 288), and mean sensitivity (median (IQR): 3.5 (2.1, 8.4) dB vs 5.1 (2.9, 9.0) dB). Longer disease duration was associated with smaller EZ area (P < 0.001) and lower mean sensitivity (P = 0.01). Better BCVA, larger EZ area, and larger CST were correlated with greater mean sensitivity (r > 0.3 and P < 0.01). Better BCVA and larger CST were associated with larger EZ area (r > 0.6 and P < 0.001).ConclusionsLonger disease duration correlated with more severe retinal structure and function abnormalities, and there were associations between MP and OCT metrics. Monitoring changes in retinal structure-function relationships during disease progression will provide important insights into disease mechanism in USH2A-related retinal degeneration.

Published
2022

5. Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials

Author

Cole, Abosede O, Gerstenblith, Adam T, Kotagiri, Ajay, Edwards, Albert O, Zambrano, Alberto D, Eaton, Alexander M, Rubowitz, Alexander, Lyon, Alice T, Chiang, Allen, Ho, Allen, Hu, Allen Y, Guerami, Amir H, Dessouki, Amr L, de Carvalho, André Corrêa Maia, Emanuelli, Andrés, Chang, Andrew A, Antoszyk, Andrew N, Francone, Anibal Andrés, Prasad, Anita, Wolf, Armin, Khanani, Arshad M, Abbey, Ashkan Michael, Moulana, Asma, Wihelm, Barbara, Sikorski, Bartosz L, Kuppermann, Baruch D, Wolff, Benjamin, Jewart, Brian H, Do, Brian K, Chan-Kai, Brian T, Mein, Calvin, Hoyng, Carel B, Awh, Carl C, Regillio, Carl, Zeolite, Carlos, Baumal, Caroline R, Creuzot-Garcher, Catherine, Maury, Catherine Français, Wykoff, Charles C, Newell, Charles K, Jhaveri, Chirag, Lohmann, Chris P, Dinah, Christiana B, Ma, Colin, Crawford, Courtney, Parke, D Wilkin, Lavinsky, Daniel, Roth, Daniel, Pieramici, Dante J, Moshfeghi, Darius M, Levin, Darrin, Saperstein, David A, Brown, David, Gaucher, David, Lally, David R, Liao, David S, Brown, David Warren, Goldstein, Debra, Marcus, Dennis, Chan, Derek G, Dhoot, Dilsher, Tacite, Domingo, Zalewski, Dominik, Espana, Edgar M, Lad, Eleonora M, Souied, Eric H, Suan, Eric P, Eting, Eva, Sola, Federico Furno, de Bats, Flore, Bandello, Francesco, Gómez-Ulla, Francisco, Devin, François, Holz, Frank G, Chen, Fred K, Makkouk, Fuad, Dyer, Gawain, Spital, George, Staurenghi, Giovanni, Stoller, Glenn, Cousins, Gwen, Salehi-Had, Hani, Agostini, Hansjürgen, Eleftheriadis, Haralabos, Weiss, Harold, Sultan, Harris C, Massé, Hélène, Pearce, Ian, Dias, Indra, Barbazetto, Irene, Rosenblatt, Irit, Suñer, Ivan J, Kovach, Jaclyn L, Kaluzny, Jakub, Borthwick, James, Howard, James G, Wong, James, Ernest, Jan, Němčanský, Jan, Ysasaga, Jason Edward, Handza, Jason M, Moreno, Javier Antonio Montero, Korobelnik, Jean-François, Heier, Jeffrey S, Arnold, Jennifer J, Brown, Jeremiah, Bafalluy, Joaquin, Pearlman, Joel, Pitcher, John D, Kitchens, John, Carlson, John P, Gilhotra, Jolly, Fein, Jordana, Monés, Jordi M, Luna, José Domingo, Moreno, José María Ruiz, Coney, Joseph M, Sallum, Juliana Maria Ferraz, Olsen, Karl R, Blobner, Katharina, Macoul, Katherine A, Oh, Kean T, Malik, Khurram Javed, Hattenbach, Lars-Olof, Kodjikian, Laurent, Neto, Laurentino Biccas, Singerman, Lawrence J, Altay, Lebriz, Sheck, Leo-H, Feiner, Leonard, Harris, Lindsey D, Chishold, Lionel D, Rao, Llewelyn J, Nehemy, Márcio Bittar, Elizalde, Maria Jose Capella, Gamulescu, Maria-Andreea, Saravia, Mario J, Johnson, Mark W, McKibbin, Martin, Maccumber, Mathew, Vidosevich, Matko, Ohr, Matthew P, Samuel, Michael A, Singer, Michael A, Cassell, Michael, Dollin, Michael, Elman, Michael J, Ip, Michael S, Goldstein, Michaella, Busquets, Miguel, Mititelu, Mihai, Shah, Milan, Veith, Miroslav, Fineman, Mitchell, Varano, Monica, Christmas, Nancy, Steinle, Nathan C, Chaudhry, Nauman, Chinskey, Nicholas D, Eter, Nicole, London, Nikolas J S, Mathalone, Nurit, Schlottmann, Patricio G, Coady, Patrick, Higgins, Patrick M, Raskauskas, Paul A, Yates, Paul A, Bernstein, Paul, Mitchell, Paul, Monsour, Paul, Raphaelian, Paul V, Stanga, Paulo E, Stodulka, Pavel, Issa, Peter Charbel, Pavan, Peter, Ferrone, Phil J, Oleksy, Piotr, Abraham, Prema, Mruthyunjaya, Prithvi, Nguyen, Quan Dong, Reddy, Rahul K, Khurana, Rahul N, Tuli, Raman, Tadayoni, Ramin, Katz, Randy Steven, Arora, Rashi, Schlingemann, Reinier O, Rosen, Richard B, Gale, Richard, Scartozzi, Richard, Isernharge, Ricky, Singh, Rishi P, Stoltz, Robert A, Avery, Robert L, Wirthlin, Robert S, Guymer, Robyn, Goldberg, Roger A, Frenkel, Ronald, Belfort, Rubens Jr, Mohand-Said, Saddek, Grisanti, Salvatore, Razavi, Sam, Fraser-Bell, Samantha, Shah, Sandeep N, Wickremasinghe, Sanjeewa, Haug, Sara Joy, Adrean, Sean D, Priglinger, Siegfried G, Esposti, Simona Degli, Guest, Stephen, Huddleston, Stephen, Itty, Sujit, Moon, Suk Jin, Bhatia, Sumit P, Gupta, Sunil, Patel, Sunil S, Garg, Sunir J, Joshi, Sunir, Nghiem-Buffet, Sylvia, Johnson, T Mark, Jaouni, Tareq, Ach, Thomas, Williams, Thomas R, Sheidow, Thomas, Cleland, Timothy P, You, Timothy T, Peto, Tunde, Konidaris, Vasileios, Gonzalez, Victor H, Korda, Vladimir, Freeman, William R, Bridges, William Z, Barak, Yoreh, Zagorski, Zbigniew, Yehoshua, Zohar, Dubska, Zora, Rosenfeld, Philip J, Guymer, Robyn H, Boyer, David, Grossi, Federico, Korobelnik, Jean-Francois, Slakter, Jason S, Waheed, Nadia K, Metlapally, Ravi, Steinle, Nathan, Francone, Anibal A, Hu, Allen, Deschatelets, Pascal, Francois, Cedric, Bliss, Caleb, Monés, Jordi, and Ribeiro, Ramiro

Published
2023
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6. The RUSH2A Study: Best-Corrected Visual Acuity, Full-Field Electroretinography Amplitudes, and Full-Field Stimulus Thresholds at Baseline.

Author

Birch, David G, Cheng, Peiyao, Duncan, Jacque L, Ayala, Allison R, Maguire, Maureen G, Audo, Isabelle, Cheetham, Janet K, Durham, Todd A, Fahim, Abigail T, Ferris, Frederick L, Heon, Elise, Huckfeldt, Rachel M, Iannaccone, Alessandro, Khan, Naheed W, Lad, Eleonora M, Michaelides, Michel, Pennesi, Mark E, Stingl, Katarina, Vincent, Ajoy, Weng, Christina Y, and Foundation Fighting Blindness Consortium Investigator Group

Subjects
Foundation Fighting Blindness Consortium Investigator Group, Usher syndrome type 2, best corrected visual acuity, electroretinography, full-field stimulus test, retinitis pigmentosa, Biomedical Engineering, Opthalmology and Optometry
Abstract

PurposeThe purpose of this study was to evaluate baseline best corrected visual acuity (BCVA), full-field electroretinography (ERG), full-field stimulus thresholds (FST), and their relationship with baseline demographic and clinical characteristics in the Rate of Progression in Usher syndrome type 2 (USH2A)-related Retinal Degeneration (RUSH2A) multicenter study.MethodsParticipants had Usher syndrome type 2 (USH2, N = 80) or autosomal recessive nonsyndromic retinitis pigmentosa (ARRP, N = 47) associated with biallelic variants in the USH2A gene. Associations of demographic and clinical characteristics with BCVA, ERG, and FST were assessed with regression models.ResultsIn comparison to ARRP, USH2 had worse BCVA (median 79 vs. 82 letters; P < 0.001 adjusted for age), lower rod-mediated ERG b-wave amplitudes (median 0.0 vs. 6.6 µV; P < 0.001) and 30 Hz flicker cone-mediated ERG amplitudes (median 1.5 vs. 3.1 µV; P = 0.001), and higher (white, blue, and red) FST thresholds (means [-26, -31, -23 dB] vs. [-39, -45, -28 dB]; P < 0.001 for all stimuli). After adjusting for age, gender, and duration of vision loss, the difference in BCVA between diagnosis groups was attenuated (P = 0.09). Only diagnosis was associated with rod- and cone-mediated ERG parameters, whereas both genders (P = 0.04) and duration of visual loss (P < 0.001) also were associated with FST white stimulus.ConclusionsUSH2 participants had worse BCVA, ERG, and FST than ARRP participants. FST was strongly associated with duration of disease; it remains to be determined whether it will be a sensitive measure of progression.Translational relevanceUsing standardized research protocols in RUSH2A, measures have been identified to monitor disease progression and treatment response and differentiate features of prognostic relevance between USH2 and ARRP participants with USH2A mutations.

Published
2020

7. Effect of Ciliary Neurotrophic Factor on Retinal Neurodegeneration in Patients with Macular Telangiectasia Type 2 A Randomized Clinical Trial

Author

Chew, Emily Y, Clemons, Traci E, Jaffe, Glenn J, Johnson, Charles A, Farsiu, Sina, Lad, Eleonora M, Guymer, Robyn, Rosenfeld, Philip, Hubschman, Jean-Pierre, Constable, Ian, Wiley, Henry, Singerman, Lawrence J, Gillies, Mark, Comer, Grant, Blodi, Barbara, Eliott, Dean, Yan, Jiong, Bird, Alan, Friedlander, Martin, and Group, Macular Telangiectasia Type 2-Phase 2 CNTF Research

Subjects
Eye Disease and Disorders of Vision, Clinical Trials and Supportive Activities, Aging, Clinical Research, Neurosciences, Neurodegenerative, Macular Degeneration, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Eye, Aged, Cell- and Tissue-Based Therapy, Ciliary Neurotrophic Factor, Drug Implants, Electroretinography, Female, Fluorescein Angiography, Humans, Intravitreal Injections, Male, Middle Aged, Photoreceptor Cells, Vertebrate, Reading, Retina, Retinal Degeneration, Retinal Telangiectasis, Single-Blind Method, Visual Acuity, Visual Fields, Macular Telangiectasia Type 2-Phase 2 CNTF Research Group, Clinical Sciences, Opthalmology and Optometry, Public Health and Health Services, Ophthalmology & Optometry
Abstract

PurposeTo test the effects of an encapsulated cell-based delivery of a neuroprotective agent, ciliary neurotrophic factor (CNTF), on progression of macular telangiectasia type 2, a neurodegenerative disease with no proven effective therapy.DesignRandomized sham-controlled clinical trial.ParticipantsNinety-nine study eyes of 67 eligible participants were enrolled.MethodsSingle-masked randomized clinical trial of 24 months' duration conducted from May 2014 through April 2017 in 11 clinical centers of retinal specialists in the United States and Australia. Participants were randomized 1:1 to surgical implantation of intravitreal sustained delivery of human CNTF versus a sham procedure.Main outcome measuresThe primary outcome was the difference in the area of neurodegeneration as measured in the area of the ellipsoid zone disruption (or photoreceptor loss) measured on spectral-domain (SD) OCT images at 24 months from baseline between the treated and untreated groups. Secondary outcomes included comparison of visual function changes between treatment groups.ResultsAmong the 67 participants who were randomized (mean age, 62±8.9 years; 41 women [61%]; 58 white persons [86%]), 65 (97%) completed the study. Two participants (3 study eyes) died and 3 participants (4 eyes) were found ineligible. The eyes receiving sham treatment had 31% greater progression of neurodegeneration than the CNTF-treated eyes. The difference in mean area of photoreceptor loss was 0.05±0.03 mm2 (P = 0.04) at 24 months. Retinal sensitivity changes, measured using microperimetry, were correlated highly with the changes in the area of photoreceptor loss (r = 0.86; P < 0.0001). The mean retinal sensitivity loss of the sham group was 45% greater than that of the treated group (decrease, 15.81±8.93 dB; P = 0.07). Reading speed deteriorated in the sham group (-13.9 words per minute) with no loss in the treated group (P = 0.02). Serious adverse ocular effects were found in 2 of 51 persons (4%) in the sham group and 2 of 48 persons (4%) in the treated group.ConclusionsIn participants with macular telangiectasia type 2, a surgical implant that released CNTF into the vitreous cavity, compared with a sham procedure, slowed the progression of retinal degeneration. Further research is needed to assess longer-term clinical outcomes and safety.

Published
2019

8. Baseline Microperimetry and OCT in the RUSH2A Study: Structure−Function Association and Correlation With Disease Severity

Author

Lad, Eleonora M., Duncan, Jacque L., Liang, Wendi, Maguire, Maureen G., Ayala, Allison R., Audo, Isabelle, Birch, David G., Carroll, Joseph, Cheetham, Janet K., Durham, Todd A., Fahim, Abigail T., Loo, Jessica, Deng, Zengtian, Mukherjee, Dibyendu, Heon, Elise, Hufnagel, Robert B., Guan, Bin, Iannaccone, Alessandro, Jaffe, Glenn J., Kay, Christine N., Michaelides, Michel, Pennesi, Mark E., Vincent, Ajoy, Weng, Christina Y., and Farsiu, Sina

Published
2022
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12. Machine Learning OCT Predictors of Progression from Intermediate Age-Related Macular Degeneration to Geographic Atrophy and Vision Loss

Author

Toth, Cynthia A., Wong, Wai, Huang, Thomas, Hubbard, G. Baker, Srivastava, Sunil, McCall, Michelle, Winter, Katrina, Sarin, Neeru, Hall, Katherine, McCollum, Patti, Curtis, Linda, Schuman, Stefanie, Chiu, Stephanie J., Farsiu, Sina, Tai, Vincent, Clemons, Traci, Chew, Emily, Lad, Eleonora M., Sleiman, Karim, Banks, David L., Hariharan, Sanjay, Herrmann, Rolf, Dauletbekov, Daniyar, Giani, Andrea, Chong, Victor, and Chew, Emily Y.

Published
2022
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20. Local Anatomic Precursors to New-Onset Geographic Atrophy in Age-Related Macular Degeneration as Defined on OCT

Author

Toth, Cynthia A., McCall, Michelle, Srivastava, Sunil, Winter, Katrina, Sarin, Neeru, Schuman, Stefanie, Chiu, Stephanie J., Farsiu, Sina, Tai, Vincent, Sevilla, Monica, Harrington, Christopher, Gunther, Randall, Tran-Viet, Du, Folgar, Francisco, Yuan, Eric, Wong, Wai, Hall, Katherine, Chew, Emily, Hwang, Thomas, McCollum, Patti, Hubbard, G. Baker, Curtis, Linda, Clemons, Traci, Harrington, Molly, Pasricha, Malini Veerappan, Sleiman, Karim, Stinnett, Sandra S., Lad, Eleonora M., Wong, Wai T., and Chew, Emily Y.

Published
2021
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26. RobOCTNet: Robotics and Deep Learning for Referable Posterior Segment Pathology Detection in an Emergency Department Population

Author

Song, Ailin, primary, Lusk, Jay B., additional, Roh, Kyung-Min, additional, Hsu, S. Tammy, additional, Valikodath, Nita G., additional, Lad, Eleonora M., additional, Muir, Kelly W., additional, Engelhard, Matthew M., additional, Limkakeng, Alexander T., additional, Izatt, Joseph A., additional, McNabb, Ryan P., additional, and Kuo, Anthony N., additional

Published
2024
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27. Dissociations of the Fluocinolone Acetonide Implant: The Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study

Author

Holbrook, Janet T, Sugar, Elizabeth A, Burke, Alyce E, Vitale, Albert T, Thorne, Jennifer E, Davis, Janet L, Jabs, Douglas A, Jaffe, Glenn J, Branchaud, Brenda, Hahn, Paul, Koreen, Larry, Lad, Eleonora M, Lin, Phoebe, Martel, Joseph Nissim, Serrano, Neha, Skalak, Cindy, Vajzovic, Lejla, Baer, Claxton, Bryant, Joyce, Chavala, Sai, Cusick, Michael, Day, Shelley, Dayani, Pouya, Ehlers, Justis, Kesen, Muge, Lee, Annie, Melamud, Alex, Qureshi, Jawad A, Scott, Adrienne Williams, See, Robert F, Shuler, Robert K, Wood, Megan, Yeh, Steven, Fernandes, Alcides, Gibbs, Deborah, Leef, Donna, Martin, Daniel F, Srivastava, Sunil, Dunn, James P, Begum, Hosne, Boring, Jeff, Brotherson, Kristen L, Burkholder, Bryn, Butler, Nicholas J, Cain, Dennis, Cook, Mary A, Emmert, David, Graul, Janis R, Herring, Mark, Laing, Ashley, Leung, Theresa G, Mahon, Michael C, Moradi, Ahmafreza, Nwankwo, Antonia, Ostheimer, Trucian L, Reed, Terry, Arnold, Ellen, Barnabie, Patricia M, Belair, Marie-Lynn, Bolton, Stephen G, Brodine, Joseph B, Brown, Diane M, Brune, Lisa M, Galor, Anat, Gan, Theresa, Jacobowitz, Adam, Kapoor, Meera, Kedhar, Sanjay, Kim, Stephen, Leder, Henry A, Livingston, Alison G, Morton, Yavette, Nolan, Kisten, Peters, George B, Soto, Priscilla, Stevenson, Ricardo, Tarver-Carr, Michelle, Wang, Yue, Foster, C Stephen, Anesi, Stephen D, Bruner, Linda, Ceron, Olga, Hinkle, David M, Persons, Nancy, Wentworth, Bailey, Acevedo, Sarah, Anzaar, Fahd, Cesca, Tom, Contero, Angelica, Fitzpatrick, Kayleigh, Goronga, Faith, Johnson, Jyothir, Lebron, Karina Q, Marvell, Danielle, Morgan, Chandra, Patel, Nita, Pinto, Jennifer, Siddique, Sana S, Sprague, Janet, and Yilmaz, Taygan

Subjects
Clinical Trials and Supportive Activities, Brain Disorders, Eye Disease and Disorders of Vision, Bioengineering, Clinical Research, Prevention, Neurosciences, Eye, Adolescent, Adult, Aged, Aged, 80 and over, Drug Implants, Equipment Failure, Female, Fluocinolone Acetonide, Follow-Up Studies, Foreign-Body Migration, Glucocorticoids, Humans, Intravitreal Injections, Male, Middle Aged, Postoperative Complications, Reoperation, Risk Factors, Time Factors, Uveitis, Visual Acuity, Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group, Clinical Sciences, Opthalmology and Optometry, Public Health and Health Services, Ophthalmology & Optometry
Abstract

PurposeTo describe fluocinolone acetonide implant dissociations in the Multicenter Uveitis Steroid Treatment (MUST) Trial.DesignRandomized clinical trial with extended follow-up.MethodsReview of data collected on the first implant in the eye(s) of participants. Dissociation was defined as the drug pellet no longer being affixed to the strut and categorized as spontaneous or surgically related.ResultsA total of 250 eyes (146 patients) had at least 1 implant placed. Median follow-up time after implant placement was 6 years (range 0.5-9.2 years). Thirty-four dissociations were reported in 30 participants. There were 22 spontaneous events in 22 participants; 6-year cumulative risk of a spontaneous dissociation was 4.8% (95% confidence interval [CI]: 2.4%-9.1%). The earliest event occurred 4.8 years after placement. Nine of 22 eyes with data had a decline in visual acuity ≥5 letters temporally related to the dissociation. Thirty-nine implant removal surgeries were performed, 33 with replacement. Twelve dissociations were noted during implant removal surgeries in 10 participants (26%, 95% CI 15%-48%); 5 of these eyes had a decline in visual acuity ≥5 letters after surgery. The time from implant placement to removal surgery was longer for the surgeries at which dissociated implants were identified than for those without one (5.7 vs 3.7 years, P < .001). Overall, visual acuity declined 15 or more letters from pre-implant values in 22% of affected eyes; declines were frequently associated with complications of uveitis or its treatment.ConclusionThere is an increasing risk of dissociation of Retisert implants during follow-up; the risk is greater with removal/exchange surgeries, but the risk of both spontaneous and surgically related events increases with longevity of the implants. In 22% of affected eyes visual acuity declined by 15 letters. In the context of eyes with moderate to severe uveitis for years, this rate is not unexpected.

Published
2016

29. Factors Predicting Visual Acuity Outcome in Intermediate, Posterior, and Panuveitis: The Multicenter Uveitis Steroid Treatment (MUST) Trial

Author

Kempen, John H, Van Natta, Mark L, Altaweel, Michael M, Dunn, James P, Jabs, Douglas A, Lightman, Susan L, Thorne, Jennifer E, Holbrook, Janet T, Jaffe, Glenn J, Branchaud, Brenda, Hahn, Paul, Koreen, Larry, Lad, Eleonora M, Lin, Phoebe, Martel, Joseph Nissim, Serrano, Neha, Skalak, Cindy, Vajzovic, Lejla, Baer, Claxton, Bryant, Joyce, Chavala, Sai, Cusick, Michael, Day, Shelley, Dayani, Pouya, Ehlers, Justis, Kesen, Muge, Lee, Annie, Melamud, Alex, Qureshi, Jawad A, Scott, Adrienne Williams, See, Robert F, Shuler, Robert K, Wood, Megan, Yeh, Steven, Fernandes, Alcides, Gibbs, Deborah, Leef, Donna, Martin, Daniel F, Srivastava, Sunil, Begum, Hosne, Boring, Jeff, Brotherson, Kristen L, Burkholder, Bryn, Butler, Nicholas J, Cain, Dennis, Cook, Mary A, Emmert, David, Graul, Janis R, Herring, Mark, Laing, Ashley, Leung, Theresa G, Mahon, Michael C, Moradi, Ahmafreza, Nwankwo, Antonia, Ostheimer, Trucian L, Reed, Terry, Arnold, Ellen, Barnabie, Patricia M, Belair, Marie-Lynn, Bolton, Stephen G, Brodine, Joseph B, Brown, Diane M, Brune, Lisa M, Galor, Anat, Gan, Theresa, Jacobowitz, Adam, Kapoor, Meera, Kedhar, Sanjay, Kim, Stephen, Leder, Henry A, Livingston, Alison G, Morton, Yavette, Nolan, Kisten, Peters, George B, Soto, Priscilla, Stevenson, Ricardo, Tarver-Carr, Michelle, Wang, Yue, Foster, C Stephen, Anesi, Stephen D, Bruner, Linda, Ceron, Olga, Hinkle, David M, Persons, Nancy, Wentworth, Bailey, Acevedo, Sarah, Anzaar, Fahd, Cesca, Tom, Contero, Angelica, Fitzpatrick, Kayleigh, Goronga, Faith, Johnson, Jyothir, Lebron, Karina Q, Marvell, Danielle, Morgan, Chandra, Patel, Nita, Pinto, Jennifer, Siddique, Sana S, and Sprague, Janet

Subjects
Clinical Trials and Supportive Activities, Clinical Research, Eye Disease and Disorders of Vision, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Eye, Aged, Drug Implants, Female, Follow-Up Studies, Glucocorticoids, Humans, Male, Middle Aged, Panuveitis, Time Factors, Tomography, Optical Coherence, Treatment Outcome, Visual Acuity, Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group, Clinical Sciences, Opthalmology and Optometry, Public Health and Health Services, Ophthalmology & Optometry
Abstract

PurposeTo identify factors associated with best-corrected visual acuity (BCVA) presentation and 2-year outcome in 479 intermediate, posterior, and panuveitic eyes.DesignCohort study using randomized controlled trial data.MethodsMulticenter Uveitis Steroid Treatment (MUST) Trial masked BCVA measurements at baseline and at 2 years follow-up used gold-standard methods. Twenty-three clinical centers documented characteristics per protocol, which were evaluated as potential predictive factors for baseline BCVA and 2-year change in BCVA.ResultsBaseline factors significantly associated with reduced BCVA included age ≥50 vs 10 vs grade 0; cataract; macular thickening; and exudative retinal detachment. Over 2 years, eyes better than 20/50 and 20/50 or worse at baseline improved, on average, by 1 letter (P = .52) and 10 letters (P < .001), respectively. Both treatment groups and all sites of uveitis improved similarly. Factors associated with improved BCVA included resolution of active AC cells, resolution of macular thickening, and cataract surgery in an initially cataractous eye. Factors associated with worsening BCVA included longer duration of uveitis (6-10 or >10 vs

Published
2015

32. Accelerated Brain Atrophy, Microstructural Decline and Connectopathy in Age-Related Macular Degeneration

Author

Stout, Jacques A., primary, Mahzarnia, Ali, additional, Dai, Rui, additional, Anderson, Robert J., additional, Cousins, Scott, additional, Zhuang, Jie, additional, Lad, Eleonora M., additional, Whitaker, Diane B., additional, Madden, David J., additional, Potter, Guy G., additional, Whitson, Heather E., additional, and Badea, Alexandra, additional

Published
2024
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36. A Deep-Learning Algorithm to Predict Short-Term Progression to Geographic Atrophy on Spectral-Domain Optical Coherence Tomography

Author

Dow, Eliot R., primary, Jeong, Hyeon Ki, additional, Katz, Ella Arnon, additional, Toth, Cynthia A., additional, Wang, Dong, additional, Lee, Terry, additional, Kuo, David, additional, Allingham, Michael J., additional, Hadziahmetovic, Majda, additional, Mettu, Priyatham S., additional, Schuman, Stefanie, additional, Carin, Lawrence, additional, Keane, Pearse A., additional, Henao, Ricardo, additional, and Lad, Eleonora M., additional

Published
2023
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39. Microglia at Sites of Atrophy Restrict the Progression of Retinal Degeneration via Galectin-3 and Trem2 Interactions

Author

Yu, Chen, primary, Lad, Eleonora M, additional, Mathew, Rose, additional, Littleton, Sejiro, additional, Chen, Yun, additional, Schlepckow, Kai, additional, Degan, Simone, additional, Chew, Lindsey, additional, Amason, Joshua, additional, Kalnitsky, Joan, additional, Bowes Rickman, Catherine, additional, Proia, Alan D, additional, Colonna, Marco, additional, Haass, Christian, additional, and Saban, Daniel, additional

Published
2023
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40. Activated cGAS/STING signaling elicits endothelial cell senescence in early diabetic retinopathy

Author

Liu, Haitao, primary, Ghosh, Sayan, additional, Vaidya, Tanuja, additional, Bammidi, Sridhar, additional, Huang, Chao, additional, Shang, Peng, additional, Nair, Archana Padmanabhan, additional, Chowdhury, Olivia, additional, Stepicheva, Nadezda A., additional, Strizhakova, Anastasia, additional, Hose, Stacey, additional, Mitrousis, Nikolaos, additional, Gadde, Santosh Gopikrishna, additional, MB, Thirumalesh, additional, Strassburger, Pamela, additional, Widmer, Gabriella, additional, Lad, Eleonora M., additional, Fort, Patrice E., additional, Sahel, José-Alain, additional, Zigler, J. Samuel, additional, Sethu, Swaminathan, additional, Westenskow, Peter D., additional, Proia, Alan D., additional, Sodhi, Akrit, additional, Ghosh, Arkasubhra, additional, Feenstra, Derrick, additional, and Sinha, Debasish, additional

Published
2023
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42. Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials

Author

Heier, Jeffrey S, Lad, Eleonora M, Holz, Frank G, Rosenfeld, Philip J, Guymer, Robyn H, Boyer, David, Grossi, Federico, Baumal, Caroline R, Korobelnik, Jean-Francois, Slakter, Jason S, Waheed, Nadia K, Metlapally, Ravi, Pearce, Ian, Steinle, Nathan, Francone, Anibal A, Hu, Allen, Lally, David R, Deschatelets, Pascal, Francois, Cedric, Bliss, Caleb, Staurenghi, Giovanni, Monés, Jordi, Singh, Rishi P, Ribeiro, Ramiro, Wykoff, Charles C, Cole, Abosede O, Gerstenblith, Adam T, Kotagiri, Ajay, Edwards, Albert O, Zambrano, Alberto D, Eaton, Alexander M, Rubowitz, Alexander, Lyon, Alice T, Chiang, Allen, Ho, Allen, Hu, Allen Y, Guerami, Amir H, Dessouki, Amr L, de Carvalho, André Corrêa Maia, Emanuelli, Andrés, Chang, Andrew A, Antoszyk, Andrew N, Francone, Anibal Andrés, Prasad, Anita, Wolf, Armin, Khanani, Arshad M, Abbey, Ashkan Michael, Moulana, Asma, Wihelm, Barbara, Sikorski, Bartosz L, Kuppermann, Baruch D, Wolff, Benjamin, Jewart, Brian H, Do, Brian K, Chan-Kai, Brian T, Mein, Calvin, Hoyng, Carel B, Awh, Carl C, Regillio, Carl, Zeolite, Carlos, Baumal, Caroline R, Creuzot-Garcher, Catherine, Maury, Catherine Français, Wykoff, Charles C, Newell, Charles K, Jhaveri, Chirag, Lohmann, Chris P, Dinah, Christiana B, Ma, Colin, Crawford, Courtney, Parke, D Wilkin, Lavinsky, Daniel, Roth, Daniel, Pieramici, Dante J, Moshfeghi, Darius M, Levin, Darrin, Saperstein, David A, Brown, David, Gaucher, David, Lally, David R, Liao, David S, Brown, David Warren, Goldstein, Debra, Marcus, Dennis, Chan, Derek G, Dhoot, Dilsher, Tacite, Domingo, Zalewski, Dominik, Espana, Edgar M, Lad, Eleonora M, Souied, Eric H, Suan, Eric P, Eting, Eva, Sola, Federico Furno, de Bats, Flore, Bandello, Francesco, Gómez-Ulla, Francisco, Devin, François, Holz, Frank G, Chen, Fred K, Makkouk, Fuad, Dyer, Gawain, Spital, George, Staurenghi, Giovanni, Stoller, Glenn, Cousins, Gwen, Salehi-Had, Hani, Agostini, Hansjürgen, Eleftheriadis, Haralabos, Weiss, Harold, Sultan, Harris C, Massé, Hélène, Pearce, Ian, Dias, Indra, Barbazetto, Irene, Rosenblatt, Irit, Suñer, Ivan J, Kovach, Jaclyn L, Kaluzny, Jakub, Borthwick, James, Howard, James G, Wong, James, Ernest, Jan, Němčanský, Jan, Ysasaga, Jason Edward, Handza, Jason M, Moreno, Javier Antonio Montero, Korobelnik, Jean-François, Heier, Jeffrey S, Arnold, Jennifer J, Brown, Jeremiah, Bafalluy, Joaquin, Pearlman, Joel, Pitcher, John D, Kitchens, John, Carlson, John P, Gilhotra, Jolly, Fein, Jordana, Monés, Jordi M, Luna, José Domingo, Moreno, José María Ruiz, Coney, Joseph M, Sallum, Juliana Maria Ferraz, Olsen, Karl R, Blobner, Katharina, Macoul, Katherine A, Oh, Kean T, Malik, Khurram Javed, Hattenbach, Lars-Olof, Kodjikian, Laurent, Neto, Laurentino Biccas, Singerman, Lawrence J, Altay, Lebriz, Sheck, Leo-H, Feiner, Leonard, Harris, Lindsey D, Chishold, Lionel D, Rao, Llewelyn J, Nehemy, Márcio Bittar, Elizalde, Maria Jose Capella, Gamulescu, Maria-Andreea, Saravia, Mario J, Johnson, Mark W, McKibbin, Martin, Maccumber, Mathew, Vidosevich, Matko, Ohr, Matthew P, Samuel, Michael A, Singer, Michael A, Cassell, Michael, Dollin, Michael, Elman, Michael J, Ip, Michael S, Goldstein, Michaella, Busquets, Miguel, Mititelu, Mihai, Shah, Milan, Veith, Miroslav, Fineman, Mitchell, Varano, Monica, Christmas, Nancy, Steinle, Nathan C, Chaudhry, Nauman, Chinskey, Nicholas D, Eter, Nicole, London, Nikolas J S, Mathalone, Nurit, Schlottmann, Patricio G, Coady, Patrick, Higgins, Patrick M, Raskauskas, Paul A, Yates, Paul A, Bernstein, Paul, Mitchell, Paul, Monsour, Paul, Raphaelian, Paul V, Stanga, Paulo E, Stodulka, Pavel, Issa, Peter Charbel, Pavan, Peter, Ferrone, Phil J, Oleksy, Piotr, Abraham, Prema, Mruthyunjaya, Prithvi, Nguyen, Quan Dong, Reddy, Rahul K, Khurana, Rahul N, Tuli, Raman, Tadayoni, Ramin, Katz, Randy Steven, Arora, Rashi, Schlingemann, Reinier O, Rosen, Richard B, Gale, Richard, Scartozzi, Richard, Isernharge, Ricky, Singh, Rishi P, Stoltz, Robert A, Avery, Robert L, Wirthlin, Robert S, Guymer, Robyn, Goldberg, Roger A, Frenkel, Ronald, Belfort, Rubens Jr, Mohand-Said, Saddek, Grisanti, Salvatore, Razavi, Sam, Fraser-Bell, Samantha, Shah, Sandeep N, Wickremasinghe, Sanjeewa, Haug, Sara Joy, Adrean, Sean D, Priglinger, Siegfried G, Esposti, Simona Degli, Guest, Stephen, Huddleston, Stephen, Itty, Sujit, Moon, Suk Jin, Bhatia, Sumit P, Gupta, Sunil, Patel, Sunil S, Garg, Sunir J, Joshi, Sunir, Nghiem-Buffet, Sylvia, Johnson, T Mark, Jaouni, Tareq, Ach, Thomas, Williams, Thomas R, Sheidow, Thomas, Cleland, Timothy P, You, Timothy T, Peto, Tunde, Konidaris, Vasileios, Gonzalez, Victor H, Korda, Vladimir, Freeman, William R, Bridges, William Z, Barak, Yoreh, Zagorski, Zbigniew, Yehoshua, Zohar, and Dubska, Zora

Abstract

Geographic atrophy is a leading cause of progressive, irreversible vision loss. The objectives of OAKS and DERBY were to assess the efficacy and safety of pegcetacoplan compared with sham treatment in patients with geographic atrophy.

Published
2023
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43. Perioperative Blindness in Spine Surgery: A Scoping Literature Review.

Author

Sperber, Jacob, Owolo, Edwin, Zachem, Tanner J., Bishop, Brandon, Johnson, Eli, Lad, Eleonora M., and Goodwin, C. Rory

Subjects
LITERATURE reviews, SPINAL surgery, BLINDNESS, SURGICAL complications, VISION disorders, RETINAL artery
Abstract

Perioperative vision loss (POVL) is a devastating surgical complication that impacts both the recovery from surgery and quality of life, most commonly occurring after spine surgery. With rates of spine surgery dramatically increasing, the prevalence of POVL will increase proportionately. This scoping review aims to aggregate the literature pertinent to POVL in spine surgery and consolidate recommendations and preventative measures to reduce the risk of POVL. There are several causes of POVL, and the main contribution following spine surgery is ischemic optic neuropathy (ION). Vision loss often manifests immediately following surgery and is irreversible and severe. Diffusion weighted imaging has recently surfaced as a diagnostic tool to identify ION. There are no effective treatments; therefore, risk stratification for counseling and prevention are vital. Patients undergoing prone surgery of long duration and/or with significant expected blood loss are at greatest risk. Future research is necessary to develop effective treatments. [ABSTRACT FROM AUTHOR]

Published
2024
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44. Robotic Optical Coherence Tomography Retinal Imaging for Emergency Department Patients: A Pilot Study for Emergency Physicians’ Diagnostic Performance

Author

Song, Ailin, primary, Roh, Kyung-Min, additional, Lusk, Jay B., additional, Valikodath, Nita G., additional, Lad, Eleonora M., additional, Draelos, Mark, additional, Ortiz, Pablo, additional, Theophanous, Rebecca G., additional, Limkakeng, Alexander T., additional, Izatt, Joseph A., additional, McNabb, Ryan P., additional, and Kuo, Anthony N., additional

Published
2023
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45. Mystery of changing choroidal thickness

Author

Montero-Hernández, Javier, primary, Remolí-Sargues, Lidia, additional, Gallego-Pinazo, Roberto, additional, Cervera-Taulet, Enrique, additional, Lujan, Brandon J., additional, Alekseev, Oleg, additional, and Lad, Eleonora M., additional

Published
2022
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48. Color Vision and Microperimetry Changes in Nonexudative Age-Related Macular Degeneration After Risuteganib Treatment: Exploratory Endpoints in a Multicenter Phase 2a Double-Masked, Randomized, Sham-Controlled, Crossover Clinical Trial

Author

Lad, Eleonora M., primary, Boyer, David S., additional, Heier, Jeffrey S., additional, Kornfield, Julie A., additional, Kuppermann, Baruch D., additional, Quiroz-Mercado, Hugo, additional, Aubel, Janine M., additional, Karageozian, Lisa S., additional, Karageozian, Hampar L., additional, Sarayba, Melvin A., additional, Karageozian, Vicken H., additional, and Kaiser, Peter K., additional

Published
2022
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50. Machine Learning OCT Predictors of Progression from Intermediate Age-Related Macular Degeneration to Geographic Atrophy and Vision Loss

Author

Lad, Eleonora M., primary, Sleiman, Karim, additional, Banks, David L., additional, Hariharan, Sanjay, additional, Clemons, Traci, additional, Herrmann, Rolf, additional, Dauletbekov, Daniyar, additional, Giani, Andrea, additional, Chong, Victor, additional, Chew, Emily Y., additional, Toth, Cynthia A., additional, Wong, Wai, additional, Huang, Thomas, additional, Hubbard, G. Baker, additional, Srivastava, Sunil, additional, McCall, Michelle, additional, Winter, Katrina, additional, Sarin, Neeru, additional, Hall, Katherine, additional, McCollum, Patti, additional, Curtis, Linda, additional, Schuman, Stefanie, additional, Chiu, Stephanie J., additional, Farsiu, Sina, additional, Tai, Vincent, additional, and Chew, Emily, additional

Published
2022
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