Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-related Macular Degeneration
- Registration Number
- NCT00541333
- Lead Sponsor
- The New York Eye & Ear Infirmary
- Brief Summary
The purpose of the project is to investigate in eyes with dry AMD, the efficacy and safety as preventive therapy of the immunomodulatory substance named copaxone which had been proven as safe and effective agent for a neurodegenerative disease, in arresting the progression as well as the conversion of dry AMD to wet AMD. The hypothesis that the immunomodulatory agent copaxone proven for a neurodegenerative disease may work in the eye is revolutionary and may open a new avenue of preventive treatment for the disease which is the major cause of legal blindness in the industrial world
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- Dry AMD in one or both eyes
- Age 50 or above of either gender
- Signed informed consent.
Exclusion Criteria
- Known sensitivity to Mannitol or Copaxone.
- Skin disease or active infection of skin.
- Active fever or active treatment for infection.
- History of other uncontrolled systemic active disease.
- Premenopausal females not using reliable birth control.
- Sensitivity to fluorescein or iodine.
- Inability to comply with study procedures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham Copaxone Injection - Copaxone Copaxone Injection -
- Primary Outcome Measures
Name Time Method Total drusen area reduction 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
New York Eye and Ear Infirmary
🇺🇸New York, New York, United States