Comparing the Effectiveness and Costs of Bevacizumab to Ranibizumab in Patients With Diabetic Macular Edema (BRDME) — BRDME  

Diabetic Macular Edema Clinical Trial

Official title: Comparing the Effectiveness and Costs of Bevacizumab to Ranibizumab in Patients With Diabetic Macular Edema (The BRDME Study)

Status Recruiting

Clinical Trial Summary

The primary objective is to demonstrate the non-inferiority of bevacizumab to ranibizumab in the treatment of patients with DME (OCT central area thickness > 275 μm) as determined by the change in best-corrected visual acuity (BCVA) in the study eye from baseline to month 6.

Clinical Trial Description

Objective: 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. It is hypothesized that bevacizumab is non-inferior to ranibizumab regarding its effectiveness.

Study design: This will be a randomized, controlled, double masked, clinical trial in 246 patients in seven academic trial centres in The Netherlands.

Study population: patients 18 years of age or higher with diabetic macular 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 best-corrected visual acuity (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 and costs per quality adjusted life-year of the two treatments. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

• NCT number: NCT01635790
• Study type: Interventional
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Reinier O Schlingemann, MD, PhD
• Phone: +31 20 5663682
• Email: r.schlingemann@amc.uva.nl
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 2012