Helsinki Retina Research Group, University of Helsinki, Helsinki, Finland.
Department of Ophthalmology, Helsinki University Hospital, Helsinki, Finland.
Adv Ther. 2020 May;37(5):2256-2266. doi: 10.1007/s12325-020-01312-2. Epub 2020 Apr 10.
To optimize the aflibercept treat-and-extend protocol in wet age-related macular degeneration (wAMD) beyond the 1-year interim report.
This 2-year prospective randomized clinical trial included 52 eyes from 52 patients with treatment-naïve wAMD. After the induction phase of three monthly aflibercept injections, patients were randomized 1:1 to two different treat-and-extend protocols. In the treat-and-extend protocol with moderate extensions (T&Em), the treatment interval was extended 1 week at a time up to 12 weeks, and then by 2 weeks up to 16 weeks. In the treat-and-extend protocol with rapid extensions (T&Er), the treatment interval was initially extended to 8 weeks, and then by 2 weeks up to 16 weeks. Main outcome measure was the number of given aflibercept injections.
At the study end point at 2 years, the mean visual gain from the baseline was 7.9 ± 14.5 letters in T&Em, compared to 10.8 ± 16.5 letters in T&Er protocol (P = 0.726). The mean decrease in central subfield macular thickness was 203.0 ± 167.4 µm in T&Em and 192.3 ± 160.2 µm in T&Er protocol (P = 0.822). Treatment interval was 10.3 ± 3.3 weeks in T&Em and 11.7 ± 3.5 in T&Er protocol (P = 0.164) at the end of year 2. The total number of injections in 2 years was 14.1 ± 3.1 in T&Em and 11.6 ± 2.0 in T&Er (P = 0.002), and the number of injections during the second year was 5.4 ± 1.8 and 4.4 ± 1.4, respectively (P = 0.043). A total of 71% of the eyes in both treatment groups had a dry macula at the study end point.
At 2 years, the anatomical and functional responses between the two treatment groups were similar. However, the number of given aflibercept injections was smaller in the rapid extensions protocol.
EU Clinical Trials Register Number, 2015-001394-41/FI.
在湿性年龄相关性黄斑变性（wAMD）的 aflibercept 治疗-延长方案中，优化治疗超过 1 年的中期报告。
这是一项为期 2 年的前瞻性随机临床试验，纳入了 52 名未经治疗的 wAMD 患者的 52 只眼。在 aflibercept 三次每月注射的诱导阶段后，患者按照 1:1 随机分为两种不同的治疗-延长方案。在适度延长的治疗-延长方案（T&Em）中，治疗间隔每次延长 1 周，最长可达 12 周，然后延长 2 周，最长可达 16 周。在快速延长的治疗-延长方案（T&Er）中，治疗间隔最初延长至 8 周，然后延长 2 周，最长可达 16 周。主要观察指标为 aflibercept 的注射次数。
在 2 年的研究终点时，与 T&Em 方案中的 10.8±16.5 个字母相比，T&Er 方案中从基线开始的平均视力增益为 7.9±14.5 个字母（P=0.726）。在 T&Em 和 T&Er 方案中，中央凹下视网膜厚度的平均减少量分别为 203.0±167.4μm 和 192.3±160.2μm（P=0.822）。在第 2 年结束时，T&Em 组的治疗间隔为 10.3±3.3 周，T&Er 组为 11.7±3.5 周（P=0.164）。在 2 年内，T&Em 组共注射 14.1±3.1 次，T&Er 组共注射 11.6±2.0 次（P=0.002），第 2 年的注射次数分别为 5.4±1.8 次和 4.4±1.4 次（P=0.043）。在两组治疗中，共有 71%的眼睛在研究结束时出现干性黄斑。
在 2 年时，两组之间的解剖学和功能反应相似。然而，快速延长方案的 aflibercept 注射次数较少。
欧盟临床试验注册编号，2015-001394-41/FI。
