Prevention of Vision Loss in Patients With Age-Related Macular Degeneration (AMD) by Intravitreal Injection of Bevacizumab and Ranibizumab

Sponsor
Klinikum Bremen-Mitte, gGmbH
Study ID
NCT00559715
Phase
PHASE3
Status
Unknown

Conditions

  • Age-Related Neovascular Macular Degeneration

Eligibility Criteria

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

Interventions

  • bevacizumab — DRUG
    1.25 mg intravitreally monthly/on demand
  • ranibizumab — DRUG
    0.5 mg intravitreally monthly/on demand

Study Details

The study is designed to demonstrate the therapeutic non-inferiority of the recombinant humanized monoclonal VEGF antibody bevacizumab administered by intravitreal injection in the treatment of AMD in comparison to the related fragment ranibizumab.

Key Dates

First listed
Nov 16, 2007
Start date
Aug 31, 2008
Status verified
Mar 2009
Primary completion
Aug 31, 2009
Completion
Aug 31, 2010

Study Design

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

Arms

  • Experimental: A
  • Active Comparator: B

Primary Outcome Measure

Proportion of patients with a loss of fewer than 15 letters at month 12 [ Time Frame: 1 year ]

Central Contacts