MAAM Study: Avastin and Macugen Versus Avastin Versus Macugen

Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Study ID
NCT00531336
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The first results of Anti-Vascular Endothelial Growth Factor (VEGF) therapy were very promising and superior to established therapies. Three different substances (all of them applied intravitreally) are available, but comparative studies have not yet been conducted. In this pilot study, the safety (number of adverse events) and efficacy (distance acuity testing retinal thickness measurement) of Avastin and Macugen applied as monotherapy will be compared to a combined treatment of Avastin followed by Macugen used for retreatment. At least equal results of the combined therapy are expected.

Key Dates

First listed
Sep 18, 2007
Start date
Jul 31, 2006
Status verified
Oct 2008
Primary completion
Dec 31, 2008
Completion
Dec 31, 2008

Study Design

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

Arms

  • Experimental: 1
    Avastin first followed by retreatment of Macugen
  • Active Comparator: 2
    Avastin intravitreally every 6 weeks
  • Active Comparator: 3
    Macugen intravitreally every 6 weeks

Primary Outcome Measure

retinal thickness [ Time Frame: 54 weeks ]

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