Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT01599650
- Phase
- PHASE3
- Status
- Completed
Conditions
- Branch Retinal Vein Occlusion
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ranibizumab — DRUG
- Laser — PROCEDURElaser photocoagulation
Study Details
This study will generate comparative data for 0.5-mg ranibizumab using PRN dosing administered with or without adjunctive laser treatment versus laser photocoagulation (the current standard of care) up to Month 6 in patients with visual impairment due to ME secondary to BRVO. Additionally the results of this study will provide long-term (24-month) safety and efficacy data for ranibizumab, administered with or without adjunctive laser treatment in this indication.
Key Dates
- First listed
- May 16, 2012
- Start date
- May 31, 2012
- Status verified
- Sep 2016
- Primary completion
- May 31, 2015
- Completion
- May 31, 2015
Study Design
- Enrollment
- 455 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: 1-ranibizumab monotherapyRanibizumab 0.5 mg
- Experimental: 2-ranibizumab with laserRanibizumab 0.5 mg + laser
- Active Comparator: 3-laser monotherapyLaser monotherapy with Ranibizumab 0.5 mg from Month 6
Primary Outcome Measure
Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO) [ Time Frame: Baseline, 6 Months ]