Goldberg Roger A, Boyer David S, Holz Frank G, MacCumber Mathew W, Garg Sunir J, Brown David M, Lad Eleonora M, Steinle Nathan, Rishi P Singh, Pearce Ian, Ach Thomas, Ribeiro Ramiro, Li Chao, Jones Daniel, Tsuboi Min, Ferrone Philip J, Baumal Caroline R, Wykoff Charles C
Ophthalmic Surg Lasers Imaging Retina. 2025 Jul;56(7):398-406. doi: 10.3928/23258160-20250217-01. Epub 2025 May 15.
This study will report safety and efficacy of pegcetacoplan for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
GALE is a phase 3, open-label, multicenter, 36-month extension of the OAKS and DERBY studies. Patients who received pegcetacoplan monthly (PM) or every other month (PEOM) in OAKS or DERBY continued the same regimen in GALE (PM-PM and PEOM-PEOM); sham-observed patients initiated pegcetacoplan, maintaining the same interval.
In the first 6 months of GALE, 3.0% of study eyes developed exudative AMD, 1.3% intraocular inflammation, 0.1% ischemic optic neuropathy, and none endophthalmitis. Pegcetacoplan reduced GA growth rate by 39% (PM-PM) and 32% (PEOM-PEOM), with increasing efficacy over time across GA subtypes. In eyes with nonsubfoveal GA, pegcetacoplan reduced GA growth rate by 45% (PM-PM) and 33% (PEOM-PEOM).
Pegcetacoplan reduced GA growth rate up to 45% with increasing efficacy over 30 months and demonstrated a favorable safety profile. .
本研究将报告聚乙二醇化醋纤肽治疗年龄相关性黄斑变性（AMD）继发地图样萎缩（GA）的安全性和有效性。
GALE研究是OAKS和DERBY研究的一项3期、开放标签、多中心、为期36个月的扩展研究。在OAKS或DERBY研究中接受每月（PM）或每两个月（PEOM）一次聚乙二醇化醋纤肽治疗的患者在GALE研究中继续相同的治疗方案（PM-PM和PEOM-PEOM）；接受假治疗观察的患者开始使用聚乙二醇化醋纤肽，并保持相同的给药间隔。
在GALE研究的前6个月，3.0%的研究眼发生渗出性AMD，1.3%发生眼内炎症，0.1%发生缺血性视神经病变，无眼内炎发生。聚乙二醇化醋纤肽使GA的增长率降低了39%（PM-PM组）和32%（PEOM-PEOM组），并且随着时间的推移，对不同GA亚型的疗效不断增加。在非黄斑中心凹下GA的眼中，聚乙二醇化醋纤肽使GA的增长率降低了45%（PM-PM组）和33%（PEOM-PEOM组）。
聚乙二醇化醋纤肽使GA增长率降低了45%，在30个月内疗效不断增加，并且显示出良好的安全性。
