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The Avastin vs Visudyne for Neovascular AMD Study

S

St. Erik Eye Hospital

Status and phase

Withdrawn
Phase 3

Conditions

Age-related Macular Degeneration

Treatments

Drug: Verteporfin photodynamic therapy (PDT)
Drug: Bevacizumab (Avastin)

Study type

Interventional

Funder types

Other

Identifiers

NCT00390026
EU2006-001200-36
AVA001

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups

Avastin
Experimental group
Treatment:
Drug: Verteporfin photodynamic therapy (PDT)
Drug: Bevacizumab (Avastin)
Visudyne
Active Comparator group
Treatment:
Drug: Verteporfin photodynamic therapy (PDT)
Drug: Bevacizumab (Avastin)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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