Mirshahi A, Roohipoor R, Lashay A, Mohammadi S-F, Abdoallahi A, Faghihi H
Eye Research Center, Farabi Eye Hospital, Medical Sciences/University of Tehran, Tehran, Iran.
Eur J Ophthalmol. 2008 Mar-Apr;18(2):263-9. doi: 10.1177/112067210801800215.
To evaluate the additional therapeutic effect of single intravitreal bevacizumab injection on standard laser treatment in the management of proliferative diabetic retinopathy.
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.
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).
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.
评估单次玻璃体内注射贝伐单抗对增殖性糖尿病视网膜病变标准激光治疗的额外治疗效果。
对40例II型高危特征增殖性糖尿病视网膜病变患者的80只眼进行了一项前瞻性、双眼对照的假手术对照临床试验。所有病例均按照早期糖尿病视网膜病变治疗研究方案接受标准激光治疗。分配到阿瓦斯汀组的眼睛在首次激光治疗时接受1.25毫克玻璃体内贝伐单抗（基因泰克公司，加利福尼亚州旧金山）注射。在基线以及第6周和第16周进行荧光素血管造影，并以盲法评估增殖性糖尿病视网膜病变的消退情况。
中位年龄为52岁（范围：39 - 68岁），30%的参与者为男性。所有患者均随访16周。在随访第6周时，总共87.5%接受阿瓦斯汀注射的眼睛和25%的假手术组眼睛显示完全消退（p<0.005）。然而，在第16周时，相当数量接受阿瓦斯汀治疗的眼睛中增殖性糖尿病视网膜病变复发，两组的完全消退率变得相同（25%；p = 1.000）；部分消退率分别为70%和65%。在接受阿瓦斯汀治疗的眼睛亚组中，多变量分析确定糖化血红蛋白是增殖性糖尿病视网膜病变复发的最强预测因素（p = 0.03）。
玻璃体内注射贝伐单抗显著增强了高危特征增殖性糖尿病视网膜病变对全视网膜光凝的短期反应，但效果是短暂的，因为许多眼睛显示出快速复发。建议进一步评估替代给药方案（多次和/或定期玻璃体内注射阿瓦斯汀）。
