The Avastin vs Visudyne for Neovascular AMD Study

This study has been withdrawn prior to enrollment.
(Lucentis, a treatment superior to PDT, has become available i Sweden.)
Sponsor:
Information provided by:
St. Erik Eye Hospital
ClinicalTrials.gov Identifier:
NCT00390026
First received: October 17, 2006
Last updated: May 24, 2007
Last verified: May 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

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

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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Photosensitizing Agents
Dermatologic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014