Natural History of Geographic Atrophy Secondary to Age-Related Macular Degeneration: Results from the Prospective Proxima A and B Clinical Trials.

Autor:	Holekamp N; Pepose Vision Institute, Chesterfield, Missouri; Washington University School of Medicine, St. Louis, Missouri., Wykoff CC; Retina Consultants of Houston, Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas., Schmitz-Valckenberg S; Department of Ophthalmology and GRADE Reading Center, University of Bonn, Bonn, Germany; Department of Ophthalmology & Visual Science, University of Utah, Salt Lake City, Utah., Monés J; Institut de la Màcula, Barcelona, Spain; Barcelona Macula Foundation, Barcelona, Spain., Souied EH; Centre Hospitalier Intercommunal, Créteil, Université Paris Est, Paris, France., Lin H; Genentech, Inc., a member of the Roche Group, South San Francisco, California. Electronic address: lin.hugh@gene.com., Rabena MD; Genentech, Inc., a member of the Roche Group, South San Francisco, California., Cantrell RA; Genentech, Inc., a member of the Roche Group, South San Francisco, California., Henry EC; Genentech, Inc., a member of the Roche Group, South San Francisco, California., Tang F; Genentech, Inc., a member of the Roche Group, South San Francisco, California., Swaminathan B; Hoffmann-La Roche Limited, Mississauga, Canada., Martin J; Genentech, Inc., a member of the Roche Group, South San Francisco, California., Ferrara D; Genentech, Inc., a member of the Roche Group, South San Francisco, California., Staurenghi G; Eye Clinic, Department of Biomedical and Clinical Science 'Luigi Sacco' Sacco Hospital, University of Milan, Milan, Italy.
Jazyk:	angličtina
Zdroj:	Ophthalmology [Ophthalmology] 2020 Jun; Vol. 127 (6), pp. 769-783. Date of Electronic Publication: 2019 Dec 14.
DOI:	10.1016/j.ophtha.2019.12.009
Abstrakt:	Purpose: To better characterize visual function decline and geographic atrophy (GA) progression secondary to age-related macular degeneration (AMD). Design: Proxima A (NCT02479386)/Proxima B (NCT02399072) were global, prospective, noninterventional, observational clinical trials. Participants: Eligible patients were aged ≥50 years. Patients in Proxima A had bilateral GA without choroidal neovascularization (CNV) in either eye (N = 295). Patients in Proxima B had GA without CNV in the study eye and CNV±GA in the fellow eye (fellow eye CNV cohort, n = 168) or GA without CNV in the study eye, no CNV/GA in the fellow eye (fellow eye intermediate AMD cohort, n = 32). Methods: Changes in visual function and imaging/anatomic parameters were evaluated over time using a mixed model for repeated measurement accounting for key baseline characteristics. Main Outcome Measures: Prespecified end points included change in GA area from baseline, best-corrected visual acuity (BCVA) score assessed by Early Treatment Diabetic Retinopathy Study (ETDRS), and visual acuity under low-luminance (LLVA). Results: At 24 months, adjusted mean (standard error) change in GA lesion area from baseline was 3.87 (0.15) mm 2 in participants with bilateral GA (Proxima A), 3.55 (0.16) mm 2 in the fellow eye CNV cohort (Proxima B), and 2.96 (0.25) mm 2 in the fellow eye intermediate AMD cohort (Proxima B). Progression of GA was greater in patients with baseline nonsubfoveal (vs. subfoveal) GA lesions and tended to increase as baseline low-luminance deficit increased (all patients). Conversion to GA or CNV in the fellow eye occurred in 30% and 6.7% of participants, respectively, in the Proxima B intermediate AMD cohort at month 12. Adjusted mean (standard error) changes in BCVA and LLVA (ETDRS letters) in the study eye from baseline to 24 months were -13.88 (1.40) and -7.64 (1.20) in Proxima A, -9.49 (1.29) and -7.57 (1.26) in Proxima B fellow eye CNV cohort, and -11.48 (3.39) and -8.37 (3.02) in Proxima B fellow eye intermediate AMD cohort, respectively. Conclusions: The prospective Proxima A and B studies highlight the severe functional impact of GA and the rapid rate of GA lesion progression over a 2-year period, including in patients with unilateral GA at baseline. (Copyright © 2019 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu