Department of Ophthalmology, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan.
Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.
Jpn J Ophthalmol. 2021 May;65(3):354-362. doi: 10.1007/s10384-021-00820-0. Epub 2021 Feb 9.
To investigate the efficacy and safety of a treat-and-extend (T&E) regimen using aflibercept (Eylea) for diabetic macular edema (DME).
Prospective, open-label, multicenter, single-arm, nonblinded clinical study.
Forty eyes of 40 patients with DME received a T&E regimen of intravitreal aflibercept injection (IAI) with the longest treatment interval set to 16 weeks and adjunct focal/grid laser for 1 year. An intent-to-treat analysis was performed using the same last-observation-carried-forward method. A per-protocol analysis was also performed for patients who completed a 1-year T&E regimen. The primary endpoints were mean changes in best-corrected visual acuity (BCVA) and central subfield macular thickness (CST) from baseline. Secondary endpoints included IAI-interval extension and resultant IAI numbers and the association between an early response to IAI and final BCVA gain at 1 year.
Thirty-one patients (77.5%) completed the 1-year aflibercept T&E regimen. In these per-protocol participants, the mean CST improvement/reduction was 187.3 ± 145.0 µm (P < .001), but the mean BCVA gain was limited to 4.3 ± 12.2 letters (P = .782). Subanalysis revealed that eyes that gained ≥ 4 letters (median at week 12) after the initial 3 consecutive IAIs (induction phase) achieved greater vision improvement (13.8 ± 9.5 letters) than did the residual eyes (- 4.3 ± 9.2 letters) at 1 year (P < .001). Treatment intervals were extended to 12 and 16 weeks in 16.1% (5/31) and 45.2% (14/31) of the patients, respectively. The mean IAI number was 7.0 ± 1.1.
The results of this study suggest that although the BCVA improvement might be somewhat less than that of frequent treatment, a T&E aflibercept regimen with the longest treatment interval set to 16 weeks is a realizable rational strategy for DME treatment over 1 year.
研究阿柏西普（艾力雅）治疗糖尿病黄斑水肿（DME）的治疗-延长（T&E）方案的疗效和安全性。
前瞻性、开放标签、多中心、单臂、非盲临床研究。
40 例 DME 患者的 40 只眼接受了玻璃体腔内阿柏西普注射（IAI）的 T&E 方案治疗，最长治疗间隔设定为 16 周，并辅助进行局部/格栅激光治疗 1 年。采用相同的最后观察向前结转方法进行意向治疗分析。对于完成 1 年 T&E 方案的患者，还进行了符合方案分析。主要终点是从基线开始最佳矫正视力（BCVA）和中央视网膜黄斑厚度（CST）的平均变化。次要终点包括 IAI 间隔延长和由此产生的 IAI 数量，以及 IAI 早期反应与 1 年最终 BCVA 获益之间的关系。
31 例患者（77.5%）完成了 1 年的阿柏西普 T&E 方案。在这些符合方案的参与者中，CST 改善/减少的平均值为 187.3±145.0μm（P<0.001），但 BCVA 增加的平均值仅为 4.3±12.2 个字母（P=0.782）。亚分析显示，在初始连续 3 次 IAI（诱导期）后获得≥4 个字母（第 12 周中位数）的眼在 1 年时获得了更大的视力改善（13.8±9.5 个字母），而其余眼则为-4.3±9.2 个字母（P<0.001）。治疗间隔分别延长至 12 周和 16 周的患者比例分别为 16.1%（5/31）和 45.2%（14/31）。IAI 的平均数量为 7.0±1.1。
本研究结果表明，尽管 BCVA 改善可能略低于频繁治疗，但最长治疗间隔设定为 16 周的 T&E 阿柏西普方案在 1 年以上的 DME 治疗中是一种可行的合理策略。
