Clinical trial NCT00390026: The Avastin vs Visudyne for Neovascular AMD Study
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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Age-related Macular Degeneration
Keywords: Neovascular age-related macular degeneration
Bevacizumab
Photodynamic therapy
Lead sponsor: St. Erik Eye Hospital
Sponsor class: OTHER
First posted: 2006-10-19
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart.
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of patients gaining more than 15 letters on the ETDRS visual acuity chart.
timeFrame: 1 year
measure: Proportion of patients losing more than 30 letters on the ETDRS visual acuity chart.
timeFrame: 1 year
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: S:t Eriks Eye Hospital
Study officials:
affiliation: S:t Erik's Eye Hospital
name: Anders Kvanta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: S:t Eriks Eye Hospital
name: Stefan Seregard, MD, PhD
role: STUDY_DIRECTOR
References: