Intravitreal Aflibercept Injection for Macular Edema Due to Central Retinal Vein Occlusion
Intravitreal Aflibercept Injection for Macular Edema Due to Central Retinal Vein Occlusion
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DOI：
10.1016/j.ophtha.2014.01.027
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发表时间：
2014-07-01
期刊：
影响因子：
13.7
通讯作者：
Haller, Julia A.
中科院分区：
文献类型：
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作者：
Heier, Jeffrey S.;Clark, W. Lloyd;Haller, Julia A.
目的：评价玻璃体内注射阿柏西普（IAI）治疗视网膜中央静脉阻塞（CRVO）继发性黄斑水肿的有效性和安全性。设计：随机、双盲、3期试验。参与者：共188例CRVO继发性黄斑水肿患者。方法：患者每4周一次接受IAI 2 mg（IAI 2 Q4）（n = 114）或假注射（n = 74），直至第24周。在第24 - 52周期间，每月对两组患者进行评估，并根据需要接受IAI或临产（PRN）（IAI 2 Q4 + PRN和假手术+ IAI PRN）。在第52至100周期间，患者至少每季度接受一次评估并接受IAI PRN。主要结果指标：主要疗效终点是从基线到第24周最佳矫正视力（BCVA）提高>= 15个字母的患者比例。结果：获得≥ 15个字母的患者比例为56.1%对12.3%（P
Purpose: To evaluate the efficacy and safety of intravitreal aflibercept injection (IAI) for the treatment of macular edema secondary to central retinal vein occlusion (CRVO).Design: Randomized, double-masked, phase 3 trial.Participants: A total of 188 patients with macular edema secondary to CRVO.Methods: Patients received IAI 2 mg (IAI 2Q4) (n = 114) or sham injections (n = 74) every 4 weeks up to week 24. During weeks 24 to 52, patients from both arms were evaluated monthly and received IAI as needed, or pro re nata (PRN) (IAI 2Q4 + PRN and sham + IAI PRN). During weeks 52 to 100, patients were evaluated at least quarterly and received IAI PRN.Main Outcome Measures: The primary efficacy end point was the proportion of patients who gained >= 15 letters in best-corrected visual acuity (BCVA) from baseline to week 24. This study reports week 100 results.Results: The proportion of patients gaining >= 15 letters was 56.1% versus 12.3% (P