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Avacincaptad Pegol for Geographic Atrophy Secondary to Age-Related Macular Degeneration: Two-Year Efficacy and Safety Results from the GATHER2 Phase 3 Trial. Avacincaptad pegol治疗年龄相关性黄斑变性继发的地理萎缩:来自GATHER2 iii期试验的2年疗效和安全性结果
IF 9.5 1区 医学 Q1 OPHTHALMOLOGY Pub Date : 2025-12-15 DOI: 10.1016/j.ophtha.2025.12.011
Arshad M Khanani, Carl J Danzig, Jeffrey S Heier, Glenn J Jaffe, Peter K Kaiser, David R Lally, Sunil S Patel, Lejla Vajzovic, Christina Y Weng, Hersh Patel, Julie Clark, Dhaval Desai, Don Luo, Erin Henry, Frank G Holz

Purpose: Avacincaptad pegol (ACP) is a pegylated RNA aptamer that inhibits complement C5. The efficacy and safety of ACP 2 mg was investigated in GATHER2, with positive year 1 results published. Herein, 2-year results are reported.

Design: Phase 3, randomized, sham-controlled study (ClincalTrials.gov identifier, NCT04435366).

Participants: Patients with non-center point-involving geographic atrophy (GA).

Methods: Eligible patients were randomized 1:1 to receive monthly ACP 2 mg (n = 225) or sham (n = 222) for 1 year. At month 12, patients who received ACP 2 mg were randomized again 1:1 to dosing every month (EM; n = 96) or every other month (EOM; n = 93) with ACP 2 mg. Patients who had received monthly sham continued with sham (n = 203).

Main outcome measures: The safety and efficacy of ACP versus sham administration over 2 years and the effect of ACP EM or EOM dosing in year 2.

Results: Overall, 175 and 184 patients in the ACP and sham group completed the study at year 2, respectively. At 2 years, treatment with ACP demonstrated a continued reduction in GA growth (slope) with both ACP EM and EOM versus sham. From baseline to year 2, the mean rate of GA area growth was 4.46 mm2 (standard error [SE], 0.25 mm2) with ACP EM and 5.18 mm2 (SE, 0.17 mm2) with sham, a difference in growth of 0.724 mm2 (95% confidence interval [CI], 0.133-1.315 mm2; P = 0.0165), representing a 14% difference. From baseline to year 2, the mean rate of GA area growth was 4.20 mm2 (SE, 0.25 mm2) with ACP EOM, a difference in growth of 0.976 mm2 (95% CI, 0.377-1.575 mm2; nominal P = 0.0015) versus sham, representing a 19% difference. The incidence of choroidal neovascularization (study eye) was 11.6% with ACP (all treated) versus 9.0% with sham over 2 years. No events of retinal vasculitis, ischemic optic neuropathy, or serious intraocular inflammation occurred over 2 years.

Conclusions: Dosing of ACP 2 mg, either EM or EOM, continued to reduce GA growth versus sham therapy over 2 years with no new safety signals compared with year 1.

Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

目的:Avacincaptad pegol (ACP)是一种抑制补体C5的聚乙二醇化RNA适配体。在GATHER2中研究了ACP 2mg的疗效和安全性,发表了阳性的第一年结果。这里报告的是2年的结果。设计:3期,2年,随机,双盲,假对照研究(NCT04435366)。研究对象:非中心点性地理萎缩(GA)患者。方法:符合条件的患者按1:1随机分为每月ACP 2mg (N=225)或假药(N=222),为期1年。在第12个月,接受ACP 2mg治疗并完成第1年的患者按1:1重新随机分配至每月(EM, n=96)或每隔一个月(EOM, n=93) ACP 2mg。每月接受假药治疗的患者继续接受假药治疗(n=203)。主要观察指标:在2年内评价ACP 2mg vs sham的安全性和有效性,并在2年内评价ACP 2mg EM或EOM给药的效果。结果:总体而言,ACP 2mg组和sham组分别有175例和184例患者在第2年完成了研究。2年后,ACP 2mg治疗显示,与假手术相比,ACP 2mg EM和EOM治疗均能持续降低GA生长(斜率)。从基线到第2年,ACP 2mg EM组GA面积平均增长率为4.46mm2(标准误差[SE]: 0.25), sham组为5.18mm2 (SE: 0.17),差异为0.724mm2(95%可信区间[CI]: 0.133,1.315; P=0.0165),差异为14%。从基线到第2年,ACP 2mg EOM的GA面积平均增长率为4.20mm2 (SE: 0.25),与假手术相比,差异为0.976mm2 (95% CI: 0.377,1.575;名义P=0.0015),差异为19%。在2年多的时间里,ACP 2mg组(全部治疗组)和假手术组的眼部不良事件(研究眼)发生率分别为64.0%和48.2%。2年内ACP 2mg组(全部治疗)脉络膜新生血管(研究眼)发生率为11.6%,假手术组为9.0%。2年内未发生视网膜血管炎、缺血性视神经病变或严重眼内炎症。结论:与假药相比,ACP 2mg (EM或EOM)的剂量在2年内继续降低GA生长,与第1年相比没有新的安全性信号。
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{"title":"Major Complications Following Strabismus Surgery: nine-year data from the IRIS® (Intelligent Research in Sight) Registry","authors":"R.Michael Siatkowski, Christie L. Morse, Robert S. Gold, Charles Li, Xuan Peng, Flora Lum","doi":"10.1016/j.ophtha.2025.11.007","DOIUrl":"https://doi.org/10.1016/j.ophtha.2025.11.007","url":null,"abstract":"","PeriodicalId":19533,"journal":{"name":"Ophthalmology","volume":"125 1","pages":""},"PeriodicalIF":13.7,"publicationDate":"2025-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145613714","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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Ophthalmology
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