The Avastin vs Visudyne for Neovascular AMD Study

Study Overview
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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.

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.

Official Title
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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)

Conditions
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Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: Bevacizumab (Avastin)
* Drug: Verteporfin photodynamic therapy (PDT)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bevacizumab (Avastin)|nan|
|Drug: Verteporfin photodynamic therapy (PDT)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients gaining more than 15 letters on the ETDRS visual acuity chart. |  |  | 
| Proportion of patients losing more than 30 letters on the ETDRS visual acuity chart. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neovascular age-related macular degeneration, Bevacizumab, Photodynamic therapy