Cai Sophie, Bressler Neil M
Retina Division, Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Curr Opin Ophthalmol. 2017 Nov;28(6):636-643. doi: 10.1097/ICU.0000000000000424.
The aim of this study was to provide clinically relevant findings from the DRCR.net Protocol T, a multicentre randomized clinical trial comparing intravitreous aflibercept, repackaged (compounded) bevacizumab and ranibizumab for vision-impairing centre-involved diabetic macular oedema (DME).
At 1 year, all three antivascular endothelial growth factor (anti-VEGF) drugs, on average, improved visual acuity. There was no difference among drugs in mean change in visual acuity from baseline among eyes with baseline Snellen equivalent visual acuity of 20/32 to 20/40, whereas aflibercept yielded superior vision outcomes among eyes with baseline visual acuity of 20/50 to 20/320. At 2 years, aflibercept remained superior, on average, to bevacizumab, but not ranibizumab, among eyes with baseline visual acuity of 20/50 to 20/320. Over 2 years, in post-hoc area-under-the-curve analysis, aflibercept vision outcomes were superior to bevacizumab or ranibizumab among these eyes. All three drugs had comparable ocular and systemic safety profiles. The substantial cost differential between aflibercept and bevacizumab raises challenges when safety and efficacy are at odds with cost-effectiveness results.
When initial visual acuity loss is mild, there are no apparent differences, on average, among aflibercept, bevacizumab and ranibizumab for treating DME. When visual acuity loss is moderate or worse, aflibercept is more likely to improve visual acuity.
本研究旨在提供DRCR.net协议T的临床相关研究结果,这是一项多中心随机临床试验,比较玻璃体内注射阿柏西普、重新包装(配制)的贝伐单抗和雷珠单抗治疗累及黄斑中心凹的视力损害性糖尿病性黄斑水肿(DME)的效果。
在1年时,平均而言,所有三种抗血管内皮生长因子(抗VEGF)药物都改善了视力。对于基线Snellen等效视力为20/32至20/40的眼睛,各药物之间的视力平均变化与基线相比无差异,而对于基线视力为20/50至20/320的眼睛,阿柏西普产生了更好的视力结果。在2年时,对于基线视力为20/50至20/320的眼睛,平均而言,阿柏西普仍然优于贝伐单抗,但不优于雷珠单抗。在2年期间,在事后曲线下面积分析中,在这些眼睛中,阿柏西普的视力结果优于贝伐单抗或雷珠单抗。所有三种药物的眼部和全身安全性特征相当。当安全性和有效性与成本效益结果不一致时,阿柏西普和贝伐单抗之间的巨大成本差异带来了挑战。
当初始视力丧失较轻时,平均而言,阿柏西普、贝伐单抗和雷珠单抗在治疗DME方面没有明显差异。当视力丧失为中度或更严重时,阿柏西普更有可能改善视力。