Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
St. Erik Eye Hospital |
---|---|
Information provided by: | St. Erik Eye Hospital |
ClinicalTrials.gov Identifier: | NCT00390026 |
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 |
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) |
Estimated Enrollment: | 100 |
Study Start Date: | November 2006 |
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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Sweden | |
S:t Eriks Eye Hospital | |
Stockholm, Sweden, SE-11282 |
Principal Investigator: | Anders Kvanta, MD, PhD | S:t Erik's Eye Hospital |
Study Director: | Stefan Seregard, MD, PhD | S:t Eriks Eye Hospital |
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 |
Neovascular age-related macular degeneration Bevacizumab Photodynamic therapy |
Eye Diseases Verteporfin Retinal Degeneration Macular Degeneration |
Bevacizumab Retinal Diseases Retinal degeneration |
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 |