Back to resultsWeekly Vaccination With Copaxone as a Potential Therapy for Dry Age-related Macular Degeneration
Primary Purpose
Dry Age Related Macular Degeneration
Status
Suspended
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Copaxone Injection
Sponsored by
About this trial
This is an interventional treatment trial for Dry Age Related Macular Degeneration focused on measuring Dry Age Related Macular Degeneration, Dry AMD
Eligibility Criteria
Inclusion Criteria:
- Dry AMD in one or both eyes
- Age 50 or above of either gender
- Signed informed consent.
Exclusion Criteria:
- Known sensitivity to Mannitol or Copaxone.
- Skin disease or active infection of skin.
- Active fever or active treatment for infection.
- History of other uncontrolled systemic active disease.
- Premenopausal females not using reliable birth control.
- Sensitivity to fluorescein or iodine.
- Inability to comply with study procedures.
Sites / Locations
- New York Eye and Ear Infirmary
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Copaxone
Sham
Arm Description
Outcomes
Primary Outcome Measures
Total drusen area reduction
Secondary Outcome Measures
Full Information
NCT ID
NCT00541333
First Posted
October 9, 2007
Last Updated
May 2, 2013
Sponsor
The New York Eye & Ear Infirmary
1. Study Identification
Unique Protocol Identification Number
NCT00541333
Brief Title
Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-related Macular Degeneration
Official Title
Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Suspended
Why Stopped
Reviewing data
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The New York Eye & Ear Infirmary
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Age Related Macular Degeneration
Keywords
Dry Age Related Macular Degeneration, Dry AMD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Copaxone
Arm Type
Active Comparator
Arm Title
Sham
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Copaxone Injection
Primary Outcome Measure Information:
Title
Total drusen area reduction
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Dry AMD in one or both eyes
Age 50 or above of either gender
Signed informed consent.
Exclusion Criteria:
Known sensitivity to Mannitol or Copaxone.
Skin disease or active infection of skin.
Active fever or active treatment for infection.
History of other uncontrolled systemic active disease.
Premenopausal females not using reliable birth control.
Sensitivity to fluorescein or iodine.
Inability to comply with study procedures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard B Rosen, MD
Organizational Affiliation
New York Eye and Ear Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Eye and Ear Infirmary
City
New York
State/Province
New York
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-related Macular Degeneration
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