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

A M E Schauwvlieghe, G Dijkman, J M Hooymans, F D Verbraak, C B Hoyng, M G W Dijkgraaf, R Van Leeuwen, J R Vingerling, A C Moll, Reinier O Schlingemann

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Abstract

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.

Original languageEnglish
Pages (from-to)71
JournalBMC Ophthalmology
Volume15
DOIs
Publication statusPublished - 2015

Keywords

  • Adolescent
  • Adult
  • Angiogenesis Inhibitors
  • Bevacizumab
  • Diabetic Retinopathy
  • Double-Blind Method
  • Drug Costs
  • Female
  • Fluorescein Angiography
  • Humans
  • Intravitreal Injections
  • Macular Edema
  • Male
  • Ranibizumab
  • Surveys and Questionnaires
  • Tomography, Optical Coherence
  • Treatment Outcome
  • Vascular Endothelial Growth Factor A
  • Visual Acuity

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