Randomized, Sham-Controlled Trial of Dexamethasone Intravitreal Implant in Patients with Macular Edema Due to Retinal Vein Occlusion
Randomized, Sham-Controlled Trial of Dexamethasone Intravitreal Implant in Patients with Macular Edema Due to Retinal Vein Occlusion
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DOI：
10.1016/j.ophtha.2010.03.032
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发表时间：
2010-06-01
期刊：
影响因子：
13.7
通讯作者：
Whitcup, Scott M.
中科院分区：
文献类型：
--
作者：
Haller, Julia A.;Bandello, Francesco;Whitcup, Scott M.
目的：评价地塞米松玻璃体内植入物(DEX植入物；OZURDEX，Allergan，Inc.，Irvine，CA)对黄斑水肿(ME)合并视网膜分支静脉阻塞(BRVO)或视网膜中央静脉阻塞(CRVO)导致视力丧失的眼睛进行比较。设计：两项相同的、多中心、掩蔽、随机、为期6个月的假对照临床试验(每项试验包括BRVO患者和CRVO患者)。参与者：总共1267名因ME而视力丧失的患者，与BRVO或CRVO相关的患者。干预：单一治疗：DEX植入物0.7 mg(n=427)，DEX植入物0.35 mg(n=414)，主要结果测量：来自两项研究的汇集数据的主要结果测量是达到A>的时间；=最佳矫正视力(BCVA)提高15个字母。结果：单次给药后，两个DEX植入物组达到15个字母的BCVA改善的时间显著少于Sham(P=15)，在第30天到90天，两个DEX植入物组的BCVA的改善显著高于Sham(P=15)(P=15)。在所有的随访中，DEX植入物0.7-mg组的BCVA的丢失显著低于Sham(P
Objective: To evaluate the safety and efficacy of dexamethasone intravitreal implant (DEX implant; OZURDEX, Allergan, Inc., Irvine, CA) compared with sham in eyes with vision loss due to macular edema (ME) associated with branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).Design: Two identical, multicenter, masked, randomized, 6-month, sham-controlled clinical trials (each of which included patients with BRVO and patients with CRVO).Participants: A total of 1267 patients with vision loss due to ME associated with BRVO or CRVO.Intervention: A single treatment with DEX implant 0.7 mg (n = 427), DEX implant 0.35 mg (n = 414), or sham (n = 426).Main Outcome Measures: The primary outcome measure for the pooled data from the 2 studies was time to achieve a >= 15-letter improvement in best-corrected visual acuity (BCVA). Secondary end points included BCVA, central retinal thickness, and safety.Results: After a single administration, the time to achieve a >= 15-letter improvement in BCVA was significantly less in both DEX implant groups compared with sham (P= 15-letter improvement in BCVA was significantly higher in both DEX implant groups compared with sham at days 30 to 90 (P= 15-letter loss in BCVA was significantly lower in the DEX implant 0.7-mg group compared with sham at all follow-up visits (P