Title

The Avastin vs Visudyne for Neovascular AMD Study
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)
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Status

    Withdrawn
  • Intervention/Treatment

    bevacizumab verteporfin ...
  • Study Participants

    100
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.
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 Started
Nov 30
2006
Last Update
May 25
2007
Estimate

Drug Bevacizumab (Avastin)

Drug Verteporfin photodynamic therapy (PDT)

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
No Results Posted