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

This study has suspended participant recruitment.
(Reviewing data)
Sponsor:
Information provided by (Responsible Party):
The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00541333
First received: October 9, 2007
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Dry Age Related Macular Degeneration
 Drug: Copaxone Injection
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-related Macular Degeneration

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The New York Eye & Ear Infirmary:

Primary Outcome Measures:
  • Total drusen area reduction [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: December 2007
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Copaxone Drug: Copaxone Injection
Sham Comparator: Sham Drug: Copaxone Injection

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541333

Locations
United States, New York
New York Eye and Ear Infirmary
New York, New York, United States
Sponsors and Collaborators
The New York Eye & Ear Infirmary
Investigators
Principal Investigator: Richard B Rosen, MD New York Eye and Ear Infirmary
  More Information

No publications provided

Responsible Party: The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier: NCT00541333     History of Changes
Other Study ID Numbers: NYEE100907
Study First Received: October 9, 2007
Last Updated: May 2, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by The New York Eye & Ear Infirmary:
Dry Age Related Macular Degeneration
Dry AMD

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Copolymer 1
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on June 18, 2013