Clinical Trial: Comparing the Effectiveness and Costs of Bevacizumab to Ranibizumab in Patients With Retinal Vein Occlusions (BRVO)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Comparing the Effectiveness and Costs of Bevacizumab to Ranibizumab in Patients With Retinal Vein Occlusions (The BRVO Study)
Brief Summary: The primary objective is to demonstrate the non-inferiority of bevacizumab in the treatment of patients with macular edema secondary to a retinal vein occlusion (branch or central) as determined by the change in best-corrected visual acuity in the study eye from baseline to month 6.
Detailed Summary:
Objective: to compare the effectiveness and costs of 1.25 mg bevacizumab to 0.5 mg ranibizumab, given as monthly intravitreal injections during 6 months.
Study Design: This will be a randomized, controlled, double masked, clinical trial in 296 patients in 7 academic trial centres in The Netherlands.
Study population: patients older than 18 years of age with macular edema secondary to a retinal vein occlusion and a best corrected visual acuity (BCVA) score between 78 and 20 letters in the study eye.
Outcomes: The primary outcome measure will be the change in BCVA in the study eye from baseline to month 6.
Secondary outcomes will be amongst others the proportion of patients with a gain of 15 letters or more and/or a BCVA of 20/40 or more at 6 months and the costs per quality adjusted life-year of the two treatments
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Current Primary Outcome: Best corrected visual acuity [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Proportion of patients with a gain or loss of 15 letters or more [ Time Frame: 6 months ]The proportion of patients with a gain or loss of 15 letters or more at 6 months compared to baseline BCVA
- Change in leakage on fluorescein angiography [ Time Frame: 6 months ]The change in leakage on fluorescein angiography at the 6 month exit visit compared to baseline
- Change in foveal thickness by optical coherence tomography [ Time Frame: 6 months ]The change in foveal thickness (central area thickness) by optical coherence tomography at 6 months compared to baseline
- The number of adverse events [ Time Frame: 6 months ]The number of adverse events that occurred in the time frame of 6 months and a classification of the type of adverse events
- Costs per quality adjusted life-year of the two treatments [ Time Frame: 6 months ]The costs per quality adjusted life-year of the two treatments, results will be based on the use of standardized health questionnaires (EQ5D or HUI3)
- The proportion of patients with a BCVA of 20/40 or more [ Time Frame: 6 months ]The proportion of patients with a BCVA of 20/40 or more at 6 months compared to baseline BCVA
Original Secondary Outcome: Same as current
Information By: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Dates:
Date Received: June 28, 2012
Date Started: June 2012
Date Completion:
Last Updated: June 30, 2015
Last Verified: June 2015