作者
Julia A Haller, Francesco Bandello, Rubens Belfort Jr, Mark S Blumenkranz, Mark Gillies, Jeffrey Heier, Anat Loewenstein, Young Hee Yoon, Jenny Jiao, Xiao-Yan Li, Scott M Whitcup, Ozurdex GENEVA Study Group
发表日期
2011/12/1
期刊
Ophthalmology
卷号
118
期号
12
页码范围
2453-2460
出版商
Elsevier
简介
OBJECTIVE
To evaluate the safety and efficacy of 1 or 2 treatments with dexamethasone intravitreal implant (DEX implant) over 12 months in eyes with macular edema owing to branch or central retinal vein occlusion (BRVO or CRVO).
DESIGN
Two identical, multicenter, prospective studies included a randomized, 6-month, double-masked, sham-controlled phase followed by a 6-month open-label extension.
PARTICIPANTS
We included 1256 patients with vision loss owing to macular edema associated with BRVO or CRVO.
METHODS
At baseline, patients received DEX implant 0.7 mg (n = 421), DEX implant 0.35 mg (n = 412), or sham (n = 423) in the study eye. At day 180, patients could receive DEX implant 0.7 mg if best-corrected visual acuity (BCVA) was <84 letters or retinal thickness was >250 μm.
MAIN OUTCOME MEASURES
The primary outcome for the open-label extension was safety; BCVA was also …
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JA Haller, F Bandello, R Belfort Jr, MS Blumenkranz… - Ophthalmology, 2011