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| Sponsor: | 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 |
| 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) |
| 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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| 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 |
|
Neovascular age-related macular degeneration Bevacizumab Photodynamic therapy |
|
Macular Degeneration Wet Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Verteporfin Bevacizumab Photosensitizing Agents Radiation-Sensitizing Agents |
Physiological Effects of Drugs Pharmacologic Actions Dermatologic Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |