Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-related Macular Degeneration

The New York Eye & Ear Infirmary

Status and phase: Suspended; Phase 1

Conditions: Dry Age Related Macular Degeneration

Treatments: Drug: Copaxone Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT00541333

NYEE100907

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 2 patient groups

Copaxone

Active Comparator group

Treatment:

Drug: Copaxone Injection

Sham

Sham Comparator group

Treatment:

Drug: Copaxone Injection