Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Branch Retinal Vein Occlusion (BRVO)
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT01976338
- Phase
- PHASE3
- Status
- Completed
Conditions
- Macular Edema Secondary to Branch Retinal Vein Occlusion
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ranibizumab 0.5 mg — DRUGintravitreal injection of 0.05 ml
- Sham injection — OTHERSham intravitreal injection
Study Details
Provided efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to BRVO
Key Dates
- First listed
- Nov 5, 2013
- Start date
- Nov 12, 2013
- Status verified
- Mar 2017
- Primary completion
- Mar 28, 2016
- Completion
- Mar 28, 2016
Study Design
- Enrollment
- 283 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Ranibizumab 0.5 mgPRN Intravitreal injection
- Sham Comparator: Sham injectionAs of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
Primary Outcome Measure
Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6 [ Time Frame: Baseline to Month 1 through Month 6 ]