Comparing the Effectiveness and Costs of Bevacizumab to Ranibizumab in Patients With Retinal Vein Occlusions (BRVO) (BRVO)
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|ClinicalTrials.gov Identifier: NCT01635803|
Recruitment Status : Unknown
Verified June 2015 by Prof. dr. R.O. Schlingemann, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was: Recruiting
First Posted : July 10, 2012
Last Update Posted : July 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Retinal Vein Occlusion||Drug: Bevacizumab Drug: Ranibizumab||Phase 2 Phase 3|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||296 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Comparing the Effectiveness and Costs of Bevacizumab to Ranibizumab in Patients With Retinal Vein Occlusions (The BRVO Study)|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||June 2016|
Active Comparator: Ranibizumab
Monthly injections with ranibizumab during 6 months
0.5mg ranibizumab administered by monthly interval for six months (6 injections).
Other Name: Lucentis
Active Comparator: Bevacizumab
Monthly injections with bevacizumab during 6 months
1.25 mg bevacizumab administered by monthly interval for six months (6 injections).
Other Name: Avastin
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635803
|Contact: Reinier O Schlingemann, PhD, MD||+31 20 firstname.lastname@example.org|
|Contact: Monique -- Wezel||+31 email@example.com|
|Academic Medical Center, Dept. Ophthalmology||Recruiting|
|Amsterdam, Netherlands, 1105 AZ|
|Contact: Reinier O Schlingemann, MD, PhD +31 205663682 firstname.lastname@example.org|
|Contact: Monique Wezel +31 205663616 email@example.com|
|Principal Investigator: Reinier O Schlingemann, MD, PhD|
|Principal Investigator:||Reinier O Schlingemann, MD, PhD||Academic Medical Center, Dept. Ophthalmology, Room A2-122, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands|