The Avastin vs Visudyne for Neovascular AMD Study
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.
Age-Related Macular Degeneration
Drug: Bevacizumab (Avastin)
Drug: Verteporfin photodynamic therapy (PDT)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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)|
- Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart.
- 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.
|Study Start Date:||November 2006|
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.
|S:t Eriks Eye Hospital|
|Stockholm, Sweden, SE-11282|
|Principal Investigator:||Anders Kvanta, MD, PhD||S:t Erik's Eye Hospital|
|Study Director:||Stefan Seregard, MD, PhD||S:t Eriks Eye Hospital|