Intravitreal Aflibercept for Diabetic Macular Edema
Intravitreal Aflibercept for Diabetic Macular Edema
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DOI：
10.1016/j.ophtha.2014.05.006
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发表时间：
2014-11-01
期刊：
影响因子：
13.7
通讯作者：
Brown, David M.
中科院分区：
文献类型：
--
作者：
Korobelnik, Jean-Francois;Do, Diana V.;Brown, David M.
目的：对血管内皮生长因子阻断剂和激光治疗糖尿病性黄斑水肿（DME）进行了头对头比较。设计：两项设计相似、双盲、随机、3期试验VISTA（DME）和VIVIDDME。参与者：我们纳入了872例（眼）1型或2型糖尿病患者，这些患者出现DME并伴有中枢受累。眼接受玻璃体内阿柏西普注射（IAI）2 mg每4周（2q4）、IAI 2 mg每8周（5个初始每月剂量后）（2q8）或黄斑激光光凝。主要疗效终点是第52周早期治疗糖尿病视网膜病变研究（ETDRS）信件中最佳矫正视力（BCVA）较基线的变化。第52周的次要疗效终点包括从基线增加>= 15个字母的眼睛的比例和通过光学相干断层扫描确定的中央视网膜厚度从基线的平均变化。IAI 2q4和2q8组与激光组相比，从基线到第52周的平均BCVA增益分别为12.5和10.7 vs 0.2个字母VISTA组为10.5和10.7个字母，VIVID组为1.2个字母（P < 0.0001）。VISTA组增加≥ 15个字母的相应比例为41.6%和31.1%，VIVID组为32.4%和33.3%，VIVID组为7.8%（P <0.0001）。类似地，VISTA组的中央视网膜厚度平均减少为185.9和183.1 μ m对73.3 μ m（P < 0.0001），VIVID组为195.0和192.4 μ m对66.2 μ m（P < 0.0001）。眼部和非眼部不良事件以及严重不良事件的总体发生率，包括抗血小板试验者协作定义的动脉血栓栓塞事件和血管死亡，在治疗组间相似。第52周时，IAI在功能和解剖终点方面表现出明显优于激光，尽管2q8组的给药间隔延长，但2q4和2q8组的疗效相似。总体而言，IAI耐受性良好。(C)2014年由美国眼科学会。
Purpose: A head-to-head comparison was performed between vascular endothelial growth factor blockade and laser for treatment of diabetic macular edema (DME).Design: Two similarly designed, double-masked, randomized, phase 3 trials, VISTA(DME) and VIVIDDME.Participants: We included 872 patients (eyes) with type 1 or 2 diabetes mellitus who presented with DME with central involvement.Methods: Eyes received either intravitreal aflibercept injection (IAI) 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 initial monthly doses (2q8), or macular laser photocoagulation.Main Outcome Measures: The primary efficacy endpoint was the change from baseline in best-corrected visual acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 52. Secondary efficacy endpoints at week 52 included the proportion of eyes that gained >= 15 letters from baseline and the mean change from baseline in central retinal thickness as determined by optical coherence tomography.Results: Mean BCVA gains from baseline to week 52 in the IAI 2q4 and 2q8 groups versus the laser group were 12.5 and 10.7 versus 0.2 letters (P < 0.0001) in VISTA, and 10.5 and 10.7 versus 1.2 letters (P < 0.0001) in VIVID. The corresponding proportions of eyes gaining >= 15 letters were 41.6% and 31.1% versus 7.8% (P < 0.0001) in VISTA, and 32.4% and 33.3% versus 9.1% (P < 0.0001) in VIVID. Similarly, mean reductions in central retinal thickness were 185.9 and 183.1 versus 73.3 mu m (P < 0.0001) in VISTA, and 195.0 and 192.4 versus 66.2 mu m (P < 0.0001) in VIVID. Overall incidences of ocular and nonocular adverse events and serious adverse events, including the Anti-Platelet Trialists' Collaboration-defined arterial thromboembolic events and vascular deaths, were similar across treatment groups.Conclusions: At week 52, IAI demonstrated significant superiority in functional and anatomic endpoints over laser, with similar efficacy in the 2q4 and 2q8 groups despite the extended dosing interval in the 2q8 group. In general, IAI was well-tolerated. (C) 2014 by the American Academy of Ophthalmology.