Dry Age Related Macular Degeneration
Conditions
Keywords
Dry Age Related Macular Degeneration, Dry AMD
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
Interventions
DRUGCopaxone Injection
Sponsors
The New York Eye & Ear Infirmary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Dry AMD in one or both eyes 2. Age 50 or above of either gender 3. Signed informed consent.
Exclusion criteria
1. Known sensitivity to Mannitol or Copaxone. 2. Skin disease or active infection of skin. 3. Active fever or active treatment for infection. 4. History of other uncontrolled systemic active disease. 5. Premenopausal females not using reliable birth control. 6. Sensitivity to fluorescein or iodine. 7. Inability to comply with study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total drusen area reduction | 1 year |
Countries
United States
Outcome results
None listed