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

NCT ID: NCT00541333

Last Updated: 2013-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Dry Age Related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Copaxone

Group Type ACTIVE_COMPARATOR

Copaxone Injection

Intervention Type DRUG

Sham

Group Type SHAM_COMPARATOR

Copaxone Injection

Intervention Type DRUG

Interventions

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Copaxone Injection

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The New York Eye & Ear Infirmary

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard B Rosen, MD

Role: PRINCIPAL_INVESTIGATOR

New York Eye and Ear Infirmary

Locations

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New York Eye and Ear Infirmary

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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NYEE100907

Identifier Type: -

Identifier Source: org_study_id

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