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SuspendedNCT00541333Updated May 3, 2013

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

A Phase 1 interventional study of Copaxone Injection in Dry Age Related Macular Degeneration, sponsored by The New York Eye & Ear Infirmary. Suspended at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2013-05-03.

Sponsored by The New York Eye & Ear Infirmary · Phase 1, Interventional, and Treatment

Why this study was suspended
Reviewing data
Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
50 Years and older
Sex
All
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Study 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

02

Conditions studied

  • Dry Age Related Macular Degeneration

Keywords

  • Dry Age Related Macular Degeneration
  • Dry AMD
03

In context

Lead sponsor

The New York Eye & Ear Infirmary is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • Active comparator
    Copaxone

    Drug: Copaxone Injection

  • Sham comparator
    Sham

    Drug: Copaxone Injection

Interventions

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What researchers measure

Primary outcomes

  1. Total drusen area reduction

    Time frame: 1 year

07

Study locations

1 site
  • New York Eye and Ear Infirmary
    New York, New York, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00541333
Lead sponsor
The New York Eye & Ear Infirmary
Responsible party
Sponsor
First posted
Oct 10, 2007
Start date
Dec 2007
Primary completion
Dec 2012
Last update
May 3, 2013

Study contacts

Richard B Rosen, MD
principal investigator · New York Eye and Ear Infirmary

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Glatiramer

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The New York Eye & Ear Infirmary

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