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

Dry Age Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00541333
• Other study ID #: NYEE100907
• Status: Suspended
• Phase: Phase 1
• First received: October 9, 2007
• Last updated: May 2, 2013
• Start date: December 2007

Study information

• Verified date: May 2013
• Source: The New York Eye & Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 15
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Age Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Copaxone Injection

Locations

Country	Name	City	State
United States	New York Eye and Ear Infirmary	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
The New York Eye & Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total drusen area reduction		1 year	No