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Comparing the effectiveness and costs of Bevacizumab to Ranibizumab in patients with Diabetic Macular Edema: a randomized clinical trial (the BRDME study)
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Comparing the effectiveness and costs of Bevacizumab to Ranibizumab in patients with Diabetic Macular Edema: a randomized clinical trial (the BRDME study)
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Comparing the effectiveness and costs of Bevacizumab to Ranibizumab in patients with Diabetic Macular Edema: a randomized clinical trial (the BRDME study)
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Journal Article
Comparing the effectiveness and costs of Bevacizumab to Ranibizumab in patients with Diabetic Macular Edema: a randomized clinical trial (the BRDME study)
2015
Overview
Background
The effectiveness of ranibizumab in the treatment of diabetic macular edema has been proven with large clinical trials. For bevacizumab only two clinical trials have been published and a head-to-head comparison is lacking to date. However, if proved non-inferior to ranibizumab, use of the off-label bevacizumab could reduce costs enormously without a loss in visual acuity. A cost-effectiveness study has been designed to substantiate this hypothesis.
Aim
To compare the effectiveness and costs of 1.25 mg of bevacizumab to 0.5 mg ranibizumab given as monthly intravitreal injections during 6 months in patients with diabetic macular edema. It is hypothesized that bevacizumab is non-inferior to ranibizumab regarding its effectiveness.
Design
This is a randomized, controlled, double masked, clinical trial in 246 patients in seven academic trial centres in The Netherlands.
Outcomes
The primary outcome measure is the change in best-corrected visual acuity (BCVA) in the study eye from baseline to month 6. Secondary outcomes are the proportions of patients with a gain or loss of 15 letters or more or a BCVA of 20/40 or more at 6 months, the change in leakage on fluorescein angiography and the change in foveal thickness by optical coherence tomography at 6 months, the number of adverse events in 6 months, and the costs per quality adjusted life-year of the two treatments.
Publisher
BioMed Central,BioMed Central Ltd,Springer Nature B.V
Subject
/ Adult
/ Angiogenesis Inhibitors - economics
/ Diabetic Retinopathy - diagnosis
/ Diabetic Retinopathy - drug therapy
/ Diabetic Retinopathy - economics
/ Female
/ Humans
/ Macular Edema - drug therapy
/ Male
/ Medicine
/ Tomography, Optical Coherence
/ Vascular endothelial growth factor
/ Vascular Endothelial Growth Factor A - antagonists & inhibitors
