Department of Ophthalmology, McGill University, Montreal, Quebec, Canada.
Department of Ophthalmology, McGill University; Eye Health MD, Montreal, Quebec, Canada.
Indian J Ophthalmol. 2021 Feb;69(2):360-367. doi: 10.4103/ijo.IJO_459_20.
A sub-population of patients with diabetic macular edema (DME) responds less effectively to off-label use of Bevacizumab. Approval of Aflibercept for DME has offered Bevacizumab nonresponders an alternative therapeutic option. Herein, we investigate the anatomical and functional changes associated with Aflibercept treatment in Bevacizumab nonresponders with chronic DME in a Canadian setting.
A retrospective study of eyes with persistent DME that were switched to Aflibercept due to nonresponse following ≥6 consecutive monthly Bevacizumab injections was performed. Anatomical and functional changes and the predictors of response were assessed using patients' characteristics prior to receiving their first (baseline) and seventh consecutive Aflibercept injections (follow-up).
Twenty-four eyes were included, with a mean age of 63.9 ± 10.7 years, an average of 16.8 ± 8.5 Bevacizumab injections prior to switching to Aflibercept, and mean follow-up duration of 11.8 ± 1.7 months following switching to Aflibercept. Best-corrected visual acuity (BCVA) improved significantly from 0.49 ± 0.13 to 0.41 ± 0.11 logMAR (P < 0.001) and central subfield thickness (CST) decreased by 119.4 μm from 409.4 ± 85.8 μm to 290.0 ± 64.5 μm (P < 0.001), with 50% of eyes showing complete anatomical response. Worse BCVA and higher CST at baseline predicted greater vision improvements (P = 0.001 and P = 0.035, respectively) while a larger decrease in CST was associated with greater baseline CST (P = 0.001) and better glycemic control (P = 0.039).
Our data from a real-world clinical setting highlight the efficacy of Aflibercept as an alternative therapeutic option for DME recalcitrant to Bevacizumab, with potential additional benefit to those with worse vision, greater CST, and better glycemic control at baseline.
患有糖尿病性黄斑水肿(DME)的患者亚群对贝伐单抗的非适应证使用反应较差。阿柏西普对 DME 的批准为贝伐单抗无应答者提供了另一种治疗选择。在此,我们在加拿大的环境中研究了对慢性 DME 且对贝伐单抗无应答的患者改用阿柏西普治疗后与解剖和功能相关的变化。
对由于接受≥6 次连续每月贝伐单抗注射后无反应而改用阿柏西普的持续性 DME 患者进行了回顾性研究。在接受首次(基线)和第七次连续阿柏西普注射之前(随访),使用患者特征评估解剖和功能变化以及反应的预测因子。
共纳入 24 只眼,平均年龄为 63.9±10.7 岁,在改用阿柏西普之前平均接受了 16.8±8.5 次贝伐单抗注射,改用阿柏西普后平均随访时间为 11.8±1.7 个月。最佳矫正视力(BCVA)从 0.49±0.13 显著提高至 0.41±0.11 logMAR(P<0.001),中央视网膜厚度(CST)从 409.4±85.8 μm 减少至 290.0±64.5 μm(P<0.001),50%的眼显示完全解剖学反应。基线时视力较差和 CST 较高预测视力改善更大(P=0.001 和 P=0.035),而 CST 较大的降幅与基线时 CST 较大(P=0.001)和更好的血糖控制(P=0.039)有关。
我们来自真实临床环境的数据强调了阿柏西普作为对贝伐单抗难治性 DME 的替代治疗选择的有效性,对于基线时视力较差、CST 较大和血糖控制较好的患者可能具有额外的益处。