NCT01635803

Comparing the Effectiveness and Costs of Bevacizumab to Ranibizumab in Patients With Retinal Vein Occlusions (BRVO)

Comparing the Effectiveness and Costs of Bevacizumab to Ranibizumab in Patients With Retinal Vein Occlusions (The BRVO Study)

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 296 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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

Conditions

• Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	Bevacizumab	1.25 mg bevacizumab administered by monthly interval for six months (6 injections).
DRUG	Ranibizumab	0.5mg ranibizumab administered by monthly interval for six months (6 injections).

Timeline

• Start date: 2012-06-01
• Primary completion: 2016-06-01
• First posted: 2012-07-10
• Last updated: 2015-07-01

Locations

1 site across 1 country: Netherlands