Systemic Avastin Therapy in Age-Related Macular Degeneration

Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Study ID
NCT00531024
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    3 intravenous infusions of 5mg/kg bevacizumab at 2 weeks intervals
  • Sodium Chloride — DRUG
    3 intravenous infusions of 100ml sodium chloride 0,9% at 2 weeks intervals

Study Details

Choroidal neovascularisation (CNV) in age-related macular degeneration is one of the major causes of blindness in the western world. It is already known that the vascular endothelial growth factor (VEGF) plays a major role in the development of CNV. Photodynamic therapy (PDT), subretinal surgery, and intravitreal injection of VEGF- inhibitors are the common treatments. These methods are either very invasive or need to be repeated several times over long periods of time in order show some effect. Furthermore PDT can only be performed in eyes with pigment epithelium detachments (PED) of maximum 50% of the avascular zone, while intravitreal injections can lead to endophthalmitis and acute glaucoma. A systemic treatment, which would only need to be administered 3 times within 6 weeks would be a major effort in macular degeneration therapy.

Key Dates

First listed
Sep 18, 2007
Start date
Aug 31, 2005
Status verified
Apr 2009
Primary completion
Jan 31, 2008
Completion
Mar 31, 2008

Study Design

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

Arms

  • Experimental: 1
    3 intravenous infusions of 5mg/kg bevacizumab at 2 weeks intervals
  • Placebo Comparator: 2
    3 intravenous infusions of 100ml sodium chloride 0,9% at 2 weeks intervals

Primary Outcome Measure

Lesion size [ Time Frame: 6 months ]

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