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The Avastin vs Visudyne for Neovascular AMD Study

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ClinicalTrials.gov Identifier: NCT00390026
Recruitment Status : Withdrawn (Lucentis, a treatment superior to PDT, has become available i Sweden.)
First Posted : October 19, 2006
Last Update Posted : May 25, 2007
Sponsor:
Information provided by:
St. Erik Eye Hospital

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.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: Bevacizumab (Avastin) Drug: Verteporfin photodynamic therapy (PDT) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
Study Start Date : November 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart.

Secondary Outcome Measures :
  1. Proportion of patients gaining more than 15 letters on the ETDRS visual acuity chart.
  2. Proportion of patients losing more than 30 letters on the ETDRS visual acuity chart.


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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00390026


Locations
Sweden
S:t Eriks Eye Hospital
Stockholm, Sweden, SE-11282
Sponsors and Collaborators
St. Erik Eye Hospital
Investigators
Principal Investigator: Anders Kvanta, MD, PhD S:t Erik's Eye Hospital
Study Director: Stefan Seregard, MD, PhD S:t Eriks Eye Hospital

Additional Information:
ClinicalTrials.gov Identifier: NCT00390026     History of Changes
Other Study ID Numbers: AVA001
EU2006-001200-36
First Posted: October 19, 2006    Key Record Dates
Last Update Posted: May 25, 2007
Last Verified: May 2007

Keywords provided by St. Erik Eye Hospital:
Neovascular age-related macular degeneration
Bevacizumab
Photodynamic therapy

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Verteporfin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents