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

This study is currently recruiting participants.

Verified by The New York Eye & Ear Infirmary, January 2008

Sponsored by:	The New York Eye & Ear Infirmary
Information provided by:	The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier:	NCT00541333

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 I

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Copolymer 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-Related Macular Degeneration

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

Primary Outcome Measures:

Total drusen area reduction

Estimated Enrollment:	30
Study Start Date:	December 2007

Eligibility

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

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.

Contacts and Locations

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

Contacts

Contact: Katy Tai, CCRC

ktai@nyee.edu

Locations

United States, New York
New York Eye and Ear Infirmary	Recruiting
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

Study ID Numbers:	NYEE100907
Study First Received:	October 9, 2007
Last Updated:	January 23, 2008
ClinicalTrials.gov Identifier:	NCT00541333
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

Study placed in the following topic categories:

Copolymer 1
Eye Diseases
Retinal Degeneration

Macular Degeneration
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009