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Systemic Avastin Therapy in Age-Related Macular Degeneration

NCT00531024 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-04-22

No results posted yet for this study

Summary

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.

Conditions

  • Macular Degeneration

Interventions

DRUG

Bevacizumab

3 intravenous infusions of 5mg/kg bevacizumab at 2 weeks intervals

DRUG

Sodium Chloride

3 intravenous infusions of 100ml sodium chloride 0,9% at 2 weeks intervals

Sponsors & Collaborators

  • The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

    lead OTHER

Principal Investigators

  • Katharina E Schmid-Kubista, MD · LBI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2008-01-31
Completion
2008-03-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00531024 on ClinicalTrials.gov