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

NCT00541333 | Suspended Phase 1 DMC

• 1 other identifier: NYEE100907
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Dry Age Related Macular Degeneration

Keywords

Dry Age Related Macular Degeneration; Dry AMD

Outcome Measures

Primary Outcomes (1)

• Total drusen area reduction

  1 year

Study Arms (2)

Copaxone

ACTIVE COMPARATOR

Drug: Copaxone Injection

Sham

SHAM COMPARATOR

Drug: Copaxone Injection

Interventions

Copaxone Injection DRUG

Copaxone; Sham

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dry AMD in one or both eyes
• Age 50 or above of either gender
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The New York Eye & Ear Infirmary: lead

Study Sites (1)

New York Eye and Ear Infirmary

New York, New York, United States

Location

MeSH Terms

Interventions

Glatiramer Acetate

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Richard B Rosen, MD

  New York Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2007
• First Posted: October 10, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2012
• Last Updated: May 3, 2013

Record last verified: 2013-05

Locations

US (1)