Effect of Intravitreal Ranibizumab Injection With Retinal Vein Occlusion (RVO)
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The purpose of this study is to evaluate the effects of intravitreal Lucentis® (Ranibizumab) and investigate the anatomical and functional improvement following this treatment in patients with macular edema due to retinal vein occlusion (RVO).
An Open-label, Nonrandomized, Phase IIIb, Single Dose Study to Evaluated the Changes in Optical Coherence Tomography (OCT) and Fluorescein Angiography (FA) After Intravitreal Injection of Lucentis® in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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The change in ETDRS visual acuity letter scores from baseline. The change in the 1-mm central retinal thickness as measured by OCT from baseline. [ Time Frame: every 4 weeks (up to 52 weeks) ]
Secondary Outcome Measures :
The intraretinal structure changes in OCT. Progression of avascular area by FA. Number of additional treatments. Intraocular safety (endophthalmitis, uveitis, increase in intraocular pressure, etc). [ Time Frame: every 4 weeks (up to 52 weeks) ]
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Signed written informed consent
Patients with macular edema due to RVO (confirmed by fundus photography, fluorescein angiography, OCT)
Male and female aged from 18 to 70
Baseline best-corrected visual acuity (BCVA) in the study eye was from 20/400 to 20/30 using ETDRS chart
Additional eye disease that could compromise VA
Intraocular surgery ≤ 1 month before day 0
Prior treatments with laser photocoagulation or other intervention for macular edema due to BRVO