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

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ClinicalTrials.gov Identifier: NCT00541333
Recruitment Status : Suspended (Reviewing data)
First Posted : October 10, 2007
Last Update Posted : May 3, 2013
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Dry Age Related Macular Degeneration Drug: Copaxone Injection Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-related Macular Degeneration
Study Start Date : December 2007
Actual Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Copaxone Drug: Copaxone Injection
Sham Comparator: Sham Drug: Copaxone Injection



Primary Outcome Measures :
  1. Total drusen area reduction [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier: NCT00541333     History of Changes
Other Study ID Numbers: NYEE100907
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: May 2013

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
Glatiramer Acetate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents