Bevacizumab-augmented retinal laser photocoagulation in proliferative diabetic retinopathy: A randomized double-masked clinical trial
Bevacizumab-augmented retinal laser photocoagulation in proliferative diabetic retinopathy: A randomized double-masked clinical trial
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DOI：
10.1177/112067210801800215
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发表时间：
2008-03-01
影响因子：
1.7
通讯作者：
Faghihi, H.
中科院分区：
文献类型：
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作者：
Mirshahi, A.;Roohipoor, R.;Faghihi, H.
目的.评价单次玻璃体内注射贝伐单抗对标准激光治疗增殖性糖尿病视网膜病变的额外治疗效果。对40例高危特征性增殖性糖尿病视网膜病变II型糖尿病患者的80只眼进行了前瞻性、对侧眼假手术对照临床试验。所有病例均根据早期治疗糖尿病视网膜病变研究方案接受标准激光治疗。Avastin分配的眼睛接受1.25 mg玻璃体内贝伐单抗（Genentech Inc.，San弗朗西斯科，CA）的第一次会议上，他们的激光治疗。在基线、第6周和第16周进行血管造影，并以盲法评估增殖性糖尿病视网膜病变的消退。中位年龄为52岁（范围：39-68岁），30%的参与者为男性。所有患者随访16周。在随访第6周时，共有87.5%的Avastin注射眼和25%的假手术组显示完全消退（p< 0.005）。然而，在第16周时，相当数量的Avastin治疗眼的PDR复发，两组的完全消退率相同（25%; p= 1.000）;部分消退率分别为70%和65%。在接受Avastin治疗的眼睛亚组中，多变量分析确定血红蛋白A1 c是增殖性糖尿病视网膜病变复发的最强预测因子（p= 0.033）。玻璃体内注射贝伐珠单抗显著增强了高风险特征性增殖性糖尿病视网膜病变对散射全视网膜激光光凝的短期反应，但效果是短暂的，因为许多眼睛显示出快速复发。建议采用替代给药（多次和/或定期玻璃体内注射安维汀）进行进一步评价。
PURPOSE. To evaluate the additional therapeutic effect of single intravitreal bevacizumab injection on standard laser treatment in the management of proliferative diabetic retinopathy.METHODS. A prospective, fellow-eye sham controlled clinical trial was conducted on 80 eyes of 40 high-risk characteristic proliferative diabetic retinopathy type II diabetics. All cases received standard laser treatment according to Early Treatment Diabetic Retinopathy Study protocol. Avastin-assigned eyes received 1.25 mg intravitreal bevacizumab (Genentech Inc., San Francisco, CA) on the first session of their laser treatments. Fluorescein angiography was performed at baseline and at weeks 6 and 16, and proliferative diabetic retinopathy regression was evaluated in a masked fashion.RESULTS. The median age was 52 years (range: 39-68) and 30% of the participants were male. All patients were followed for 16 weeks. A total of 87.5% of Avastin-injected eyes and 25% of sham group showed complete regression at week 6 of follow-up (p< 0.005). However, at week 16, PDR recurred in a sizable number of the Avastin-treated eyes, and the complete regression rate in the two groups became identical (25%; p= 1.000); partial regression rates were 70% vs 65%. In the subgroup of Avastin-treated eyes, multivariate analysis identified hemoglobin A1c as the strongest predictor of proliferative diabetic retinopathy recurrence (p= 0.033).CONCLUSIONS. Intravitreal bevacizumab remarkably augmented the short-term response to scatter panretinal laser photocoagulation in high-risk characteristic proliferative diabetic retinopathy but the effect was short-lived, as many of the eyes showed rapid recurrence. Alternative dosing (multiple and/or periodic intravitreal Avastin injections) is recommended for further evaluation.