Comparing the Effectiveness and Costs of Bevacizumab to Ranibizumab in Patients With Retinal Vein Occlusions (BRVO)

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study ID
NCT01635803
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Retinal Vein Occlusion

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    1.25 mg bevacizumab administered by monthly interval for six months (6 injections).
  • Ranibizumab — DRUG
    0.5mg ranibizumab administered by monthly interval for six months (6 injections).

Study Details

The primary objective is to demonstrate the non-inferiority of bevacizumab in the treatment of patients with macular edema secondary to a retinal vein occlusion (branch or central) as determined by the change in best-corrected visual acuity 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
296 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ranibizumab
    Monthly injections with ranibizumab during 6 months
  • Active Comparator: Bevacizumab
    Monthly injections with bevacizumab during 6 months

Primary Outcome Measure

Best corrected visual acuity [ Time Frame: 6 months ]

Central Contacts

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