American journal of ophthalmology · 2025
Visual Acuity and Quality of Life Outcomes With Pegcetacoplan Treatment: A Post Hoc Analysis From the OAKS and DERBY Trials.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование III фазыНазвание и аннотация: Перевод пока не подготовлен
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Chiang Allen, Davis Matthew, Stevens Warren, Garg Sunir, Sheidow Tom, Jones Daniel L, Intorcia Michele, McKeown Alex, Schmidt-Erfurth Ursula M, Sarda Sujata P, Baumal Caroline R
Аннотация
OBJECTIVE: To evaluate the effect of pegcetacoplan on visual function and patient quality of life (QoL) measures based on distance of geographic atrophy (GA) lesions from the center of the fovea.
DESIGN: Post hoc analysis from OAKS and DERBY, two global, 24-month, multicenter, randomized, double-masked, sham-controlled phase 3 studies evaluating pegcetacoplan treatment for GA in age-related macular degeneration (AMD).
PARTICIPANTS: 888 study patients with GA for whom all data necessary for the post hoc analysis to be performed had been collected were included.
METHODS: Best-corrected visual acuity (BCVA) and 25-item National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) were assessed at baseline and every 4 and 6 months, respectively, to completion at month 24 in both pegcetacoplan-treated eyes and sham (observed) eyes. Eyes were stratified based on optical coherence tomography‒derived GA lesion location ≥250 µm (n = 192) or <250 µm (n = 696) from the foveal center.
MAIN OUTCOME MEASURES: Change from baseline in BCVA and NEI VFQ-25 was evaluated over 24 months in GA lesions based on distance (≥250 or <250 µm) from the foveal center. Adjustment was conducted via propensity score weighting, where model specification and baseline covariate selection were done a priori based on clinical rationale.
RESULTS: Pegcetacoplan-treated eyes with GA lesion margins ≥250 µm from the foveal center demonstrated directionally slower decline in visual acuity (mean +5.6 [SE 3.2] [P = .0785]) and QoL (mean +4.0 [SE 2.4] [P = .0905]) from baseline at 24 months compared with sham. The change in visual acuity (BCVA, mean -1.6 [SE 1.1] [P = .1522]) and QoL (NEI VFQ-25, -2.3 [1.1] [P = .0284]) in pegcetacoplan-treated eyes with GA lesion margins <250 µm from the foveal center were within the limits of variability compared with sham.
CONCLUSIONS: Pegcetacoplan treatment demonstrated a potentially meaningful slower decline in visual acuity and QoL for patients with GA lesions ≥250 µm from the foveal center. The change in visual acuity and QoL seen with pegcetacoplan treatment for patients with GA lesions <250 µm from the foveal center were within the limits of variability.
DESIGN: Post hoc analysis from OAKS and DERBY, two global, 24-month, multicenter, randomized, double-masked, sham-controlled phase 3 studies evaluating pegcetacoplan treatment for GA in age-related macular degeneration (AMD).
PARTICIPANTS: 888 study patients with GA for whom all data necessary for the post hoc analysis to be performed had been collected were included.
METHODS: Best-corrected visual acuity (BCVA) and 25-item National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) were assessed at baseline and every 4 and 6 months, respectively, to completion at month 24 in both pegcetacoplan-treated eyes and sham (observed) eyes. Eyes were stratified based on optical coherence tomography‒derived GA lesion location ≥250 µm (n = 192) or <250 µm (n = 696) from the foveal center.
MAIN OUTCOME MEASURES: Change from baseline in BCVA and NEI VFQ-25 was evaluated over 24 months in GA lesions based on distance (≥250 or <250 µm) from the foveal center. Adjustment was conducted via propensity score weighting, where model specification and baseline covariate selection were done a priori based on clinical rationale.
RESULTS: Pegcetacoplan-treated eyes with GA lesion margins ≥250 µm from the foveal center demonstrated directionally slower decline in visual acuity (mean +5.6 [SE 3.2] [P = .0785]) and QoL (mean +4.0 [SE 2.4] [P = .0905]) from baseline at 24 months compared with sham. The change in visual acuity (BCVA, mean -1.6 [SE 1.1] [P = .1522]) and QoL (NEI VFQ-25, -2.3 [1.1] [P = .0284]) in pegcetacoplan-treated eyes with GA lesion margins <250 µm from the foveal center were within the limits of variability compared with sham.
CONCLUSIONS: Pegcetacoplan treatment demonstrated a potentially meaningful slower decline in visual acuity and QoL for patients with GA lesions ≥250 µm from the foveal center. The change in visual acuity and QoL seen with pegcetacoplan treatment for patients with GA lesions <250 µm from the foveal center were within the limits of variability.