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 ]

The primary outcome is the change in best-corrected visual acuitiy (BCVA) in the study eye from baseline to month 6 assessed with EDTRS-like VA charts at an initial distance of four meter.


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