California Retina Consultants, Santa Barbara, California.
Regeneron Pharmaceuticals, Inc., Tarrytown, New York.
Ophthalmol Retina. 2021 Feb;5(2):141-150. doi: 10.1016/j.oret.2020.07.003. Epub 2020 Jul 9.
PURPOSE: To assess the influence of baseline choroidal neovascularization (CNV) features on visual change and fluid resolution after anti-vascular endothelial growth factor (VEGF) treatment of eyes with neovascular age-related macular degeneration (nAMD). DESIGN: Post hoc analysis of 52-week data from the phase 3 Vascular Endothelial Growth Factor VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD) Studies (VIEW) 1 and 2 clinical trials. PARTICIPANTS: One thousand eight hundred four patients with nAMD. METHODS: Integrated data from VIEW 1 and 2 of 1804 eyes receiving intravitreal aflibercept injections (IAIs) 2 mg every 4 weeks, IAIs 2 mg every 8 weeks after 3 initial monthly doses, and ranibizumab every 4 weeks with documented baseline CNV type, total area, and leakage area were analyzed. Time to an event and cumulative incidence were evaluated by Kaplan-Meier analysis, and relative risks were estimated using proportional hazards analysis. MAIN OUTCOMES MEASURES: Cumulative incidence of time to first sustained vision gain of 15 or more Early Treatment Diabetic Retinopathy Study letters, vision loss of more than 5 Early Treatment Diabetic Retinopathy Study letters from baseline, as well as first sustained absence of retinal fluid and intraretinal fluid as evaluated by OCT with respect to CNV type, total CNV, and leakage area. RESULTS: Eyes with predominantly classic CNV (mean best-corrected visual acuity [BCVA], 48.2 letters at baseline) showed a higher incidence rate of first sustained gain of 15 letters or more than eyes with occult CNV (mean BCVA, 57.9 letters at baseline; P < 0.01). Eyes with occult CNV at baseline showed higher incidence rates of first sustained absence of retinal fluid and of intraretinal fluid than eyes with predominantly classic CNV (both P < 0.01). With increasing baseline CNV total area and leakage area, the incidence rate of first sustained gain of 15 letters or more decreased. CONCLUSIONS: This post hoc analysis provided additional evidence for the role of baseline CNV features (CNV type, total area, and leakage area) in influencing visual and anatomic outcomes in eyes with nAMD after anti-VEGF treatment.
目的:评估新生血管性年龄相关性黄斑变性(nAMD)患者接受抗血管内皮生长因子(VEGF)治疗后,基线脉络膜新生血管(CNV)特征对视功能变化和液体消退的影响。
设计:对为期 52 周的 VEGF 陷阱眼:湿性年龄相关性黄斑变性(AMD)研究的疗效和安全性(VIEW)1 和 2 期临床试验的 3 期血管内皮生长因子 VEGF 数据进行事后分析。
参与者:1804 例 nAMD 患者。
方法:对 VIEW 1 和 2 中接受玻璃体内阿柏西普 2mg 每 4 周(2mgIAI4w)、前 3 个月每月注射 3 次后每 8 周注射 2mg(2mgIAI8w)和雷珠单抗每 4 周治疗的 1804 只眼的基线 CNV 类型、总面积和渗漏面积进行整合数据分析。采用 Kaplan-Meier 分析评估事件时间和累积发生率,采用比例风险分析估计相对风险。
主要结局测量:根据 CNV 类型、总 CNV 和渗漏面积,评估首次持续获得 15 个或更多早期治疗糖尿病视网膜病变研究(ETDRS)字母视力增益、基线视力损失超过 5 个 ETDRS 字母、首次持续无视网膜和视网膜内液的累积发生率。
结果:以经典型 CNV 为主的眼(基线最佳矫正视力[BCVA],48.2 个字母)的首次持续获得 15 个字母或更多字母的发生率高于隐匿型 CNV 眼(基线 BCVA,57.9 个字母;P <0.01)。基线隐匿型 CNV 眼首次持续无视网膜和视网膜内液的发生率高于以经典型 CNV 为主的眼(均 P <0.01)。随着基线 CNV 总面积和渗漏面积的增加,首次持续获得 15 个字母或更多字母的发生率降低。
结论:这项事后分析为基线 CNV 特征(CNV 类型、总面积和渗漏面积)在影响抗 VEGF 治疗后 nAMD 患者的视功能和解剖学结局方面的作用提供了额外的证据。
Cochrane Database Syst Rev. 2016-2-8