The Avastin vs Visudyne for Neovascular AMD Study

Phase 3

Withdrawn

• Conditions: Age-related Macular Degeneration
• Interventions: Drug: Bevacizumab (Avastin); Drug: Verteporfin photodynamic therapy (PDT)

• Registration Number: NCT00390026
• Lead Sponsor: St. Erik Eye Hospital

Brief Summary

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.

Detailed Description

Neovascular age-related macular degeneration (AMD) is caused by an ingrowth of pathological vessels under the macula. Experimental studies have demonstrated that vascular endothelial growth factor (VEGF) is centrally involved in this process. Current treatment options have up until now been limited to photodynamic therapy (PDT) where a photosensitizing agent in combination with laser is used to occlude the pathologic vessels. Anti-VEGF agents have recently become available making them a potentially attractive treatment alternative for neovascular AMD. We will compare the effect intravitreally administered bevacizumab with conventional PDT in a prospective, randomized and controlled trial including 100 patients (50 patients receiving either treatment regimen). Non-treated patients will receive either sham-injection or sham-PDT. The primary endpoint of the study is the amount of patients losing less than 15 letters on the ETDRS visual acuity chart. The study will go on for 2 years with an interim report after 1 year.

Study Timeline

• Study First Submitted: 2006-10-17
• Study First Submitted QC: 2006-10-17
• Study First Posted: 2006-10-19
• Study Start: 2006-11
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-28
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Visudyne	Verteporfin photodynamic therapy (PDT)	-
Avastin	Verteporfin photodynamic therapy (PDT)	-
Avastin	Bevacizumab (Avastin)	-
Visudyne	Bevacizumab (Avastin)	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart.	1 year

Secondary Outcome Measures

Name	Time	Method
Proportion of patients gaining more than 15 letters on the ETDRS visual acuity chart.	1 year
Proportion of patients losing more than 30 letters on the ETDRS visual acuity chart.	1 year

Trial Locations

Locations (1)

S:t Eriks Eye Hospital; 🇸🇪 Stockholm, Sweden