drugset / Trial / NCT01635790
Comparing the Effectiveness and Costs of Bevacizumab to Ranibizumab in Patients With Diabetic Macular Edema (BRDME)
Phase 2/3
Unknown
246 enrolled
Prof. dr. R.O. Schlingemann
Erasmus Medical Center · collabLeiden University Medical Center · collabRadboud University Medical Center · collabUMC Utrecht · collabUniversitair Ziekenhuis Brussel · collabUniversity Medical Center Groningen · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2012-06
- Primary completion
- 2016-06
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bevacizumab | Monoclonal antibody | 1.25 mg | Intravitreal |
| Comparator | Ranibizumab | Monoclonal antibody | 0.5 mg | Intravitreal |