Status:
TERMINATED
Ranibizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion in Patients With Fair Vision
Lead Sponsor:
Seoul National University Bundang Hospital
Collaborating Sponsors:
Samsung Medical Center
Novartis
Conditions:
Branch Retinal Vein Occlusion
Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the effect of ranibizumab for the treatment of macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in patients with initial fair visual acuit...
Detailed Description
Lucentis was approved for ME due to BRVO based on the results from BRAVO study. The inclusion criteria in BRAVO was "best corrected visual acuity (BCVA) 20/40 to 20/320". Therefore, the patients with ...
Eligibility Criteria
Inclusion
- Foveal center-involving macular edema secondary to BRVO diagnosed within 12 months before study enrollment
- ETDRS chart BCVA: 63 to 77 letters (20/32 to 20/50 Snellen equivalent)
- CFT \>= 300 um (mean of measurements obtained at screening and Day 0)
- Signed consent informed
- male or female, age ≥18 years old
Exclusion
- Prior episode of RVO: Past history of RVO in the study eye diagnosed before 1 year of study enrollment.
- BCVA improvement \>10 letters between screening and Day 0
- History of other ocular diseases (e.g. diabetic retinopathy, age-related macular degeneration)
- Laser treatment within 3 months before baseline
- Intraocular corticosteroid use within 3 months before baseline
- Anti-vascular endothelial growth factor (VEGF) treatment in the study or fellow eye within 3 months before baseline
- Intraocular surgery other than cataract surgery, Cataract surgery within 6 months before baseline
- Stroke or myocardial infarction ≤3 months before baseline
- Pregnancy or plan to have baby in female
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01795209
Start Date
January 1 2013
End Date
December 1 2017
Last Update
September 19 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Bundang Hospital
Seongnam, Gyunggi-do, South Korea, 463-707
2
Samsung Medical Center
Seoul, South Korea, 135-710