Purpose: To determine the prevalence of retinal vascular abnormalities (RVA) in neovascular age-related macular degeneration (AMD).
Methods: A post hoc subanalysis of images acquired during a Phase III randomized controlled trial was undertaken, selecting images from participants with untreated, neovascular AMD in at least one eye. Protocol mandated fundus photographs and fluorescein angiograms were acquired at baseline and Year 2, from 107 sham-treated study eyes with neovascular AMD and 107 untreated fellow eyes. Images were reanalyzed by an independent reading center for the presence of RVA, defined as at least one of the following: microaneurysms, vessel staining or leakage, dilated or tortuous vessels, intraretinal hemorrhage, vessel sheathing or narrowing, capillary nonperfusion, or capillary infarcts.
Results: The baseline prevalence of RVA in the sham-treated study eyes was 14.4% (15 of 104 gradable images) versus 8.3% (5 of 60) in the fellow eyes with dry AMD. The baseline prevalence of individual RVAs in study eyes was: microaneurysms (6.7%), vessel staining or leakage (6.7%), dilated or tortuous vessels (4.8%), intraretinal hemorrhage (4.8%), vessel sheathing or narrowing (2.9%), capillary nonperfusion (0%), and capillary infarcts (0%). Results were similar at 24 months.
Conclusion: Compared with several studies that relied solely on fundus photographs, this study included fluorescein angiography and found a higher prevalence of RVAs occurring in eyes with neovascular AMD.
Combined analysis of fundus photographs and fluorescein angiograms reveals that retinopathy is present in 14% of eyes with neovascular age-related macular degeneration.
*Department of Ophthalmology, School of Medicine, King's College London, London, United Kingdom;
†Fundus Photograph Reading Center, University of Wisconsin, Madison, Wisconsin;
‡Department of Ophthalmology, Hospital das Clinicas, University of São Paulo, São Paulo, Brazil;
§Digital Angiography Reading Center, New York, New York;
¶Oraya Therapeutics, Inc, Newark, California; and
**Department of Ophthalmology, Byers Eye Institute, Horngren Family Vitreoretinal Center, Stanford University School of Medicine, Palo Alto, California.
Reprint requests: Timothy L. Jackson, PhD, FRCOphth, King's Health Partners, Department of Ophthalmology, King's College Hospital, London SE5 9RS, United Kingdom; e-mail: email@example.com
Supported by Oraya.
T. L. Jackson's employer received research funding from Oraya, NeoVista, and Novartis for other trials, but not in relation to the work reported herein. E. M. Shusterman and D. J. O'Shaughnessy are employees of Oraya. The reading centers that employ R. P. Danis and J. S. Slakter received research funding from Oraya and NeoVista. R. P. Danis, J. S. Slakter, and D. M. Moshfeghi are consultants to Oraya. T. L. Jackson served on an Oraya Advisory Board and has received conference support from Oraya. D. M. Moshfeghi is a shareholder in Oraya. M. Goldbaum is a consultant to Valeant Pharmaceuticals.