美国佛罗里达州坦帕市Jaeb健康研究中心Adam R. Glassman团队研究了阿柏西普单药或优先使用贝伐单抗治疗糖尿病性黄斑水肿的疗效与安全性。该项研究成果发表在2022年7月14日出版的《新英格兰医学杂志》上。

对于患有糖尿病性黄斑水肿的眼睛，如果眼睛状况没有得到充分改善（一种阶梯疗法），则与贝伐单抗相比，优先使用阿柏西普或改用阿柏西普的相对疗效尚不清楚。

在54个临床机构，研究组随机将患有糖尿病性黄斑水肿并累及黄斑中心且视力字母分数为24到69（在0到100的范围内，分数越高表明视力越好；Snellen当量，20/320到20/50）的成年人的眼睛分组，分别接受玻璃体腔内注射2.0 mg阿柏西普或1.25 mg贝伐单抗。随机给药，然后根据预先指定的再治疗方案给药。

从12周开始，如果符合方案规定的标准，优先接受贝伐单抗治疗组的眼睛被切换到阿柏西普治疗。主要结局是2年试验期内视力的平均变化。还评估了视网膜中央亚区厚度、2年时的视力和安全性。

共有312眼（270名成年人）接受了随机分组；158眼被分配接受阿柏西普单药治疗，154眼优先接受贝伐单抗治疗。在2年的时间里，优先接受贝伐单抗组中70%的眼睛改用阿柏西普治疗。

阿柏西普单药治疗组的平均视力改善15.0个字母，优先接受贝伐单抗组的平均视力改善14.0个字母，组间差异不显著。2年时，两组的视力和视网膜中央亚区厚度的平均变化相似。

阿柏西普单药治疗组有52%的患者发生严重不良事件，显著高于优先接受贝伐单抗组（36%）；阿柏西普单药治疗组有48%的患者因不良事件而住院，显著高于优先接受贝伐单抗组（32%）。

综上，在这项涉及糖尿病性黄斑水肿引起的中度视力丧失的治疗试验中，研究组未发现在2年的时间内，阿柏西普单药治疗与贝伐单抗治疗之间的视力结果存在显著差异，在出现反应不佳的情况下，可优先改用阿柏西普。

附：英文原文

Title: Aflibercept Monotherapy or Bevacizumab First for Diabetic Macular Edema | NEJM

Author: Chirag D. Jhaveri, M.D.,, Adam R. Glassman, M.S.,, Frederick L. Ferris, III, M.D.,, Danni Liu, M.S.P.H.,, Maureen G. Maguire, Ph.D.,, John B. Allen, M.D.,, Carl W. Baker, M.D.,, David Browning, M.D., Ph.D.,, Matthew A. Cunningham, M.D.,, Scott M. Friedman, M.D.,, Lee M. Jampol, M.D.,, Dennis M. Marcus, M.D.,, Daniel F. Martin, M.D.,, Carin M. Preston, M.P.H.,, Cynthia R. Stockdale, M.S.P.H.,, and Jennifer K. Sun, M.D., M.P.H.

Issue&Volume: 2022-07-14

Abstract:

Background

In eyes with diabetic macular edema, the relative efficacy of administering aflibercept monotherapy as compared with bevacizumab first with a switch to aflibercept if the eye condition does not improve sufficiently (a form of step therapy) is unclear.

Methods

At 54 clinical sites, we randomly assigned eyes in adults who had diabetic macular edema involving the macular center and a visual-acuity letter score of 24 to 69 (on a scale from 0 to 100, with higher scores indicating better visual acuity; Snellen equivalent, 20/320 to 20/50) to receive either 2.0 mg of intravitreous aflibercept or 1.25 mg of intravitreous bevacizumab. The drug was administered at randomization and thereafter according to the prespecified retreatment protocol. Beginning at 12 weeks, eyes in the bevacizumab-first group were switched to aflibercept therapy if protocol-specified criteria were met. The primary outcome was the mean change in visual acuity over the 2-year trial period. Retinal central subfield thickness and visual acuity at 2 years and safety were also assessed.

Results

A total of 312 eyes (in 270 adults) underwent randomization; 158 eyes were assigned to receive aflibercept monotherapy and 154 to receive bevacizumab first. Over the 2-year period, 70% of the eyes in the bevacizumab-first group were switched to aflibercept therapy. The mean improvement in visual acuity was 15.0 letters in the aflibercept-monotherapy group and 14.0 letters in the bevacizumab-first group (adjusted difference, 0.8 letters; 95% confidence interval, 0.9 to 2.5; P=0.37). At 2 years, the mean changes in visual acuity and retinal central subfield thickness were similar in the two groups. Serious adverse events (in 52% of the patients in the aflibercept-monotherapy group and in 36% of those in the bevacizumab-first group) and hospitalizations for adverse events (in 48% and 32%, respectively) were more common in the aflibercept-monotherapy group.

Conclusions

In this trial of treatment of moderate vision loss due to diabetic macular edema involving the center of the macula, we found no evidence of a significant difference in visual outcomes over a 2-year period between aflibercept monotherapy and treatment with bevacizumab first with a switch to aflibercept in the case of suboptimal response.

DOI: 10.1056/NEJMoa2204225

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2204225