Effect of Intravitreal Ranibizumab Injection With Retinal Vein Occlusion (RVO)
Phase 3
Completed
- Conditions
- Macular EdemaRetinal Vein Occlusion
- Registration Number
- NCT00942864
- Lead Sponsor
- Novartis Korea Ltd.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- 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
Exclusion Criteria
- Additional eye disease that could compromise VA
- Ocular inflammation
- Intraocular surgery ≤ 1 month before day 0
- Uncontrolled glaucoma
- Prior treatments with laser photocoagulation or other intervention for macular edema due to BRVO
- Patients aged under 18 or over 71
- Female patient in pregnancy or breast feeding
- Not suitable to regular follow up
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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. every 4 weeks (up to 52 weeks)
- Secondary Outcome Measures
Name Time Method 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). every 4 weeks (up to 52 weeks)
Trial Locations
- Locations (1)
Dept. of ophthalmology, Kyung Hee University Medical Center
🇰🇷Seoul, Korea, Republic of