The Avastin vs Visudyne for Neovascular AMD Study
Information source: St. Erik Eye Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Age-Related Macular Degeneration
Intervention: Bevacizumab (Avastin) (Drug); Verteporfin photodynamic therapy (PDT) (Drug)
Phase: Phase 3
Status: Withdrawn
Sponsored by: St. Erik Eye Hospital Official(s) and/or principal investigator(s):
Anders Kvanta, MD, PhD, Principal Investigator, Affiliation: S:t Erik's Eye Hospital
Stefan Seregard, MD, PhD, Study Director, Affiliation: S:t Eriks Eye Hospital
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart.
Secondary outcome: 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.
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
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
S:t Eriks Eye Hospital, Stockholm SE-11282, Sweden
Additional Information
Hospital homepage
Starting date: November 2006
Last updated: May 24, 2007
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