30个月以上地理萎缩的Pegcetacoplan：来自OAKS， DERBY和GALE长期扩展研究的数据。

IF 0.9 4区医学 Q4 OPHTHALMOLOGY

Ophthalmic surgery, lasers & imaging retina Pub Date : 2025-05-15 DOI:10.3928/23258160-20250217-01

Roger A Goldberg, David S Boyer, Frank G Holz, Mathew W MacCumber, Sunir J Garg, David M Brown, Eleonora M Lad, Nathan Steinle, Rishi P Singh, Ian Pearce, Thomas Ach, Ramiro Ribeiro, Chao Li, Daniel Jones, Min Tsuboi, Philip J Ferrone, Caroline R Baumal, Charles C Wykoff

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引用次数: 0

摘要

背景和目的：本研究将报道pegcetacoplan治疗年龄相关性黄斑变性（AMD）继发性地理萎缩（GA）的安全性和有效性。患者和方法：GALE是OAKS和DERBY研究的3期、开放标签、多中心、36个月的延伸。在OAKS或DERBY中每月或每隔一个月接受pegcetacoplan治疗的患者在GALE中继续接受相同的治疗方案（PM-PM和PEOM-PEOM）；假观察的患者开始使用pegcetacoplan，保持相同的间隔时间。结果：在GALE的前6个月，3.0%的研究眼发生渗出性AMD， 1.3%的眼内炎症，0.1%的缺血性视神经病变，无眼内炎。Pegcetacoplan降低了39% （PM-PM）和32% （PEOM-PEOM）的GA生长速率，随着时间的推移，GA亚型的疗效越来越高。在非中央凹下GA的眼睛中，pegcetacoplan可使GA生长速率降低45% （PM-PM）和33% （PEOM-PEOM）。结论：Pegcetacoplan将GA生长速率降低了45%，并且在30个月内疗效增加，并且显示出良好的安全性。[眼科外科激光成像视网膜2025；56:XX-XX]。

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Pegcetacoplan for Geographic Atrophy Over 30 Months: Data From OAKS, DERBY, and the GALE Long-Term Extension Study.

Background and objective: This study will report safety and efficacy of pegcetacoplan for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Patients and methods: 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.

Results: 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).

Conclusion: Pegcetacoplan reduced GA growth rate up to 45% with increasing efficacy over 30 months and demonstrated a favorable safety profile. [Ophthalmic Surg Lasers Imaging Retina 2025;56:XX-XX.].

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来源期刊

Ophthalmic surgery, lasers & imaging retina OPHTHALMOLOGY-SURGERY

CiteScore

1.80

自引率

0.00%

发文量

期刊介绍： OSLI Retina focuses exclusively on retinal diseases, surgery and pharmacotherapy. OSLI Retina will offer an expedited submission to publication effort of peer-reviewed clinical science and case report articles. The front of the journal offers practical clinical and practice management features and columns specific to retina specialists. In sum, readers will find important peer-reviewed retina articles and the latest findings in techniques and science, as well as informative business and practice management features in one journal.