玻璃体内注射阿柏西普治疗新生血管性年龄相关性黄斑变性的疗效和安全性：ARIES 研究：一项随机临床试验。
EFFICACY AND SAFETY OF INTRAVITREAL AFLIBERCEPT USING A TREAT-AND-EXTEND REGIMEN FOR NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: The ARIES Study: A Randomized Clinical Trial.
机构信息
Department of Ophthalmology, Centre for Vision Research, Westmead Institute for Medical Research, University of Sydney, Sydney, NSW, Australia.
Department of Ophthalmology, University of Bonn, Bonn, Germany.
出版信息
Retina. 2021 Sep 1;41(9):1911-1920. doi: 10.1097/IAE.0000000000003128.
BACKGROUND/PURPOSE: Treating neovascular age-related macular degeneration with intravitreal aflibercept treat-and-extend (T&E) can reduce treatment burden. ARIES assessed whether intravitreal aflibercept early-start T&E was noninferior to late-start T&E.
METHODS
A randomized, open-label, Phase 3b/4 study that included treatment-naïve patients aged ≥50 years with the best-corrected visual acuity 73-25 Early Treatment Diabetic Retinopathy Study letters and active choroidal neovascularization secondary to AMD. Patients received 2 mg intravitreal aflibercept at Week (W) 0, W4, W8, and W16. At W16, patients were randomized 1:1 to early-start (2W interval adjustments) or late-start T&E (8W intervals until W48 then 2W interval adjustments). Primary endpoint: the best-corrected visual acuity change from randomization to W104.
RESULTS
Two-hundred seventy-one patients were randomized. The mean (SD) best-corrected visual acuity at baseline was 60.2 (12.1; early-T&E) and 61.3 (10.8; late-T&E) letters. The mean (SD) best-corrected visual acuity change (W16-104) was -2.1 (11.4) versus -0.4 (8.4) letters (early-T&E vs. late-T&E; least-squares mean difference: -2.0; 95% confidence interval: -4.75 to 0.71; P = 0.0162 for noninferior); +4.3 (13.4) versus +7.9 (11.9) letters (W0-104). The mean (SD) number of injections was 12.0 (2.3) versus 13.0 (1.8). From baseline to W104, 93.4% and 96.2% maintained best-corrected visual acuity; the mean (SD) central retinal thickness change was -161.6 (135.6) µm and -158.6 (125.1) µm. The last injection interval (W104) was ≥12W for 47.2% and 51.9% of patients.
CONCLUSION
Outcomes were similar between patients with neovascular age-related macular degeneration treated with an intravitreal aflibercept early-T&E or late-T&E regimen after initial dosing, with one injection difference over 2 years.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02581891 https://clinicaltrials.gov/ct2/show/NCT02581891. Supplemental Digital Contents (files 1 http://links.lww.com/IAE/B419).
背景/目的：玻璃体内注射阿柏西普的治疗和扩展（T&E）治疗年龄相关性黄斑变性新生血管可以减轻治疗负担。ARIES 评估了玻璃体内注射阿柏西普早期开始 T&E 是否不劣于晚期开始 T&E。
方法
这是一项随机、开放标签、3b/4 期研究，纳入了 271 名年龄≥50 岁、最佳矫正视力 73-25 早期治疗糖尿病视网膜病变研究字母和由 AMD 引起的活动性脉络膜新生血管的治疗初治患者。患者在第 0、4、8 和 16 周接受 2 毫克玻璃体内注射阿柏西普。在第 16 周，患者以 1:1 的比例随机分为早期开始（2 周间隔调整）或晚期开始 T&E（8 周，直到第 48 周，然后 2 周间隔调整）。主要终点：从随机化到第 104 周的最佳矫正视力变化。
结果
271 名患者被随机分组。基线时平均（SD）最佳矫正视力为 60.2（12.1；早期 T&E）和 61.3（10.8；晚期 T&E）字母。最佳矫正视力变化（第 16 周到第 104 周）为-2.1（11.4）与-0.4（8.4）字母（早期 T&E 与晚期 T&E；最小二乘均数差：-2.0；95%置信区间：-4.75 至 0.71；P=0.0162 为非劣效性）；+4.3（13.4）与+7.9（11.9）字母（第 0 周到第 104 周）。平均（SD）注射次数为 12.0（2.3）与 13.0（1.8）。从基线到第 104 周，93.4%和 96.2%的患者保持最佳矫正视力；平均（SD）中心视网膜厚度变化为-161.6（135.6）µm 和-158.6（125.1）µm。最后一次注射间隔（第 104 周）对于 47.2%和 51.9%的患者≥12 周。
结论
在初始剂量后，接受玻璃体内注射阿柏西普早期 T&E 或晚期 T&E 方案治疗的年龄相关性黄斑变性新生血管患者的结局相似，2 年内的注射次数差异为 1 次。
临床试验注册
ClinicalTrials.gov 标识符：NCT02581891 https://clinicaltrials.gov/ct2/show/NCT02581891.补充数字内容（文件 1 http://links.lww.com/IAE/B419）。
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