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The Avastin vs Visudyne for Neovascular AMD Study
This study has been withdrawn prior to recruitment.
Sponsored by: St. Erik Eye Hospital
Information provided by: St. Erik Eye Hospital
ClinicalTrials.gov Identifier: NCT00390026
  Purpose

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 Intervention Phase
Age-Related Macular Degeneration
Drug: Bevacizumab (Avastin)
Drug: Verteporfin photodynamic therapy (PDT)
Phase III

Genetics Home Reference related topics: X-linked juvenile retinoschisis
MedlinePlus related topics: Macular Degeneration
Drug Information available for: Bevacizumab Verteporfin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy 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)

Further study details as provided by St. Erik Eye Hospital:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 100
Study Start Date: November 2006
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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Hospital homepage  This link exits the ClinicalTrials.gov site

Study ID Numbers: AVA001, EU2006-001200-36
Study First Received: October 17, 2006
Last Updated: May 24, 2007
ClinicalTrials.gov Identifier: NCT00390026  
Health Authority: Sweden: Medical Products Agency

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

Study placed in the following topic categories:
Eye Diseases
Verteporfin
Retinal Degeneration
Macular Degeneration
Bevacizumab
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:
Photosensitizing Agents
Radiation-Sensitizing Agents
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009