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

Sponsor
Prof. dr. R.O. Schlingemann
Study ID
NCT01635790
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    0.5 mg ranibizumab. Given as monthly intravitreal injections during 6 months
  • Bevacizumab — DRUG
    1.25 mg of bevacizumab; Given as monthly intravitreal injections during 6 months

Study Details

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.

Key Dates

First listed
Jul 10, 2012
Start date
Jun 30, 2012
Status verified
Jun 2015
Primary completion
Jun 30, 2016

Study Design

Enrollment
246 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ranibizumab
    0.5 mg ranibizumab. Given as monthly intravitreal injections during 6 months
  • Active Comparator: Bevacizumab
    1.25 mg of bevacizumab; Given as monthly intravitreal injections during 6 months

Primary Outcome Measure

Best Corrected Visual Acuity [ Time Frame: 6 months ]

Central Contacts

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