Comparing the effectiveness and costs of Bevacizumab to Ranibizumab in patients with Diabetic Macular Edema: a randomized clinical trial (the BRDME study)

BMC Ophthalmology

Study Protocol

M.G.W. Dijkgraaf¹  A.M.E. Schauwvlieghe²  F.D. Verbraak³  Reinier O. Schlingemann⁴  J.R. Vingerling⁵  G. Dijkman⁶  C.B. Hoyng⁷  J.M. Hooymans⁸  R. Van Leeuwen⁹  A.C. Moll^1,10 

[1] Clinical Research Unit, Academic Medical Center, Amsterdam, The Netherlands;Department of Ophthalmology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands;Department of Ophthalmology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands;Ocular Angiogenesis Group, Departments of Ophthalmology and Cell Biology and Histology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands;Department of Biomedical Engineering and Physics, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands;Department of Ophthalmology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands;Ocular Angiogenesis Group, Departments of Ophthalmology and Cell Biology and Histology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands;Netherlands Institute for Neurosciences, Amsterdam, The Netherlands;Medical Retina Unit and Ocular Angiogenesis Group, Department Of Ophthalmology, Academic Medical Center, PO Box 22660, Room A2-122, 1100 DD, Amsterdam, The Netherlands;Department of Ophthalmology, Erasmus Medical Center, Rotterdam, The Netherlands;Department of Epidemiology, Erasmus Medical Center, Rotterdam, The Netherlands;Department of Ophthalmology, Leiden University Medical Centre, Leiden, The Netherlands;Department of Ophthalmology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands;Department of Ophthalmology, University Medical Center Groningen, Groningen, The Netherlands;Department of Ophthalmology, University Medical Center Utrecht, Utrecht, The Netherlands;Department of Ophthalmology, VU University Medical Centre, Amsterdam, The Netherlands;

关键词: Diabetic retinopathy;    Diabetic macular edema;    VEGF;    Ranibizumab;    Lucentis;    Bevacizumab;    Avastin;    Randomized clinical trial;   

DOI  :  10.1186/s12886-015-0043-x

 received in 2015-03-31, accepted in 2015-05-19,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundThe 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.AimTo 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.DesignThis is a randomized, controlled, double masked, clinical trial in 246 patients in seven academic trial centres in The Netherlands.OutcomesThe 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.

【 授权许可】

Unknown   
© Schauwvlieghe et al. 2015. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.