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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
296
1.25 mg bevacizumab administered by monthly interval for six months (6 injections).
0.5mg ranibizumab administered by monthly interval for six months (6 injections).
Academic Medical Center, Dept. Ophthalmology
Amsterdam, Netherlands
RECRUITINGBest corrected visual acuity
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.
Time frame: 6 months
Proportion of patients with a gain or loss of 15 letters or more
The proportion of patients with a gain or loss of 15 letters or more at 6 months compared to baseline BCVA
Time frame: 6 months
Change in leakage on fluorescein angiography
The change in leakage on fluorescein angiography at the 6 month exit visit compared to baseline
Time frame: 6 months
Change in foveal thickness by optical coherence tomography
The change in foveal thickness (central area thickness) by optical coherence tomography at 6 months compared to baseline
Time frame: 6 months
The number of adverse events
The number of adverse events that occurred in the time frame of 6 months and a classification of the type of adverse events
Time frame: 6 months
Costs per quality adjusted life-year of the two treatments
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)
Time frame: 6 months
The proportion of patients with a BCVA of 20/40 or more
The proportion of patients with a BCVA of 20/40 or more at 6 months compared to baseline BCVA
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Time frame: 6 months