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Clinical trial

A Prospective, Randomized, Double-masked, Controlled Study on Intravitreal Bevacizumab (Avastin) Versus Verteporfin (Visudyne) Photodynamic Therapy (PDT) for Patients With Neovascular Age-related Macular Degeneration (AMD)

ID
Name
AVA001
Description
The object of the study is to compare the treatment effect of bevacizumab (Avastin), an antibody targeting vascular endothelial growth factor, with verteporfin photodynamic therapy (PDT) for patients with neovascular age-related macular degeneration, the leading cause of vision severe loss in the Western world.
Trial arms
Trial start
2006-11-01
Estimated PCD
2008-11-01
Trial end
2008-11-01
Status
Withdrawn
Phase
Early phase I
Treatment
Bevacizumab (Avastin)
Arms:
Avastin, Visudyne
Verteporfin photodynamic therapy (PDT)
Arms:
Avastin, Visudyne
Primary endpoint
Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart.
1 year
Eligibility criteria
Inclusion Criteria: * patients with subfoveal neovascular AMD with either classic/predominantly classic or small occult lesions * visual acuity \>=0.1 Exclusion Criteria: * patients with subfoveal neovascular AMD with minimally classic lesions or large occult lesions * subfoveal hemorrhage (\>1DA) or fibrosis * patients previously treated for neovascular AMD in the study eye
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2024-01-31

1 organization

2 products

1 indication

Organization
St. Erik Eye Hospital
Product
Bevacizumab
Indication
Macular Degeneration
Product
Verteporfin