Geographic atrophy lesions may initially appear outside the fovea with relatively normal central vision, but vision loss inevitably progresses in eyes with GA once the central fovea is affected, the rate of vision loss increases precipitously. Geographic atrophy (GA) is the advanced stage of dry age-related macular degeneration (AMD) and is characterized by the loss of retinal photoreceptors, retinal pigment epithelium (RPE), and choriocapillaris. Trial Registration Identifier: NCT02503332 Compared with sham treatment, the relative risk of progression at 12 months from iRORA to cRORA was 0.61 (95% CI, 0.37-1.00) for eyes in the pegcetacoplan monthly group and 0.74 (95% CI, 0.54-1.02) for eyes in the pegcetacoplan every other month group.Ĭonclusions and Relevance Eyes receiving intravitreal pegcetacoplan had lower rates of progression from iRORA to cRORA compared with controls, suggesting a potential role for pegcetacoplan therapy earlier in the progression of AMD prior to the development of GA. At 12 months, progression from iRORA to cRORA occurred in 50.0% of study eyes (9 of 18) in the pegcetacoplan monthly group ( P = .02 vs sham), 60.6% of study eyes (20 of 33) in the pegcetacoplan every other month group ( P = .06 vs sham), and 81.8% of study eyes (27 of 33) in the sham group. Results Among the 167 patients in the study, at baseline, iRORA was present in 45.0% of study eyes (18 of 40) in the pegcetacoplan monthly group, 61.8% of study eyes (34 of 55) in the pegcetacoplan every other month group, and 50.7% of study eyes (34 of 67) in the sham group. Primary outcome measures were progression from iRORA to complete RPE and outer retina atrophy (cRORA) from baseline to 6 and 12 months. Main Outcomes and Measures Masked readers analyzed spectral-domain optical coherence tomography scans in regions beyond a perimeter of 500 μm from the GA border according to the Classification of Atrophy Meetings criteria. Interventions Intravitreal pegcetacoplan, 15 mg, or sham injection, monthly or every other month for 12 months. Participants comprised 167 patients with GA secondary to AMD who received pegcetacoplan monthly (n = 41) or every other month (n = 56) or a sham injection (n = 70) in the FILLY trial, completed the month 12 study visit, and did not develop exudative AMD. Objective To evaluate the potential association of pegcetacoplan with progression of iRORA in eyes with GA secondary to AMD.ĭesign, Setting, and Participants This post hoc analysis of the phase 2 multicenter, randomized, single-masked, sham-controlled FILLY trial of intravitreal pegcetacoplan for 12 months took place from February 2 to July 7, 2020. Importance Change in areas of incomplete retinal pigment epithelium (RPE) and outer retinal atrophy (iRORA) within eyes with geographic atrophy (GA) might reflect similar changes among eyes with drusen but no GA. Shared Decision Making and Communication.Scientific Discovery and the Future of Medicine.Health Care Economics, Insurance, Payment.Clinical Implications of Basic Neuroscience. Challenges in Clinical Electrocardiography.
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