The Avastin vs Visudyne for Neovascular AMD Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Age-related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Avastin

Group Type EXPERIMENTAL

Bevacizumab (Avastin)

Intervention Type DRUG

Verteporfin photodynamic therapy (PDT)

Intervention Type DRUG

Visudyne

Group Type ACTIVE_COMPARATOR

Bevacizumab (Avastin)

Intervention Type DRUG

Verteporfin photodynamic therapy (PDT)

Intervention Type DRUG

Interventions

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Bevacizumab (Avastin)

Intervention Type DRUG

Verteporfin photodynamic therapy (PDT)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No