NCT00466076

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
Last Updated

April 27, 2007

Status Verified

April 1, 2007

First QC Date

April 25, 2007

Last Update Submit

April 25, 2007

Conditions

Macular Degeneration

Keywords

DrusenAMDDry form of Age related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Total drusen area reduction

Interventions

Copaxone (Glatiramer acetate)DRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dry AMD in both eyes
  • Age 50 or above.
  • 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 active disaese.
  • Premenapausal females not using relibale birth control.
  • Sensitivity for flourescein or iodine.
  • Inability to comply with study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Kaplan Medical Center

Rehovot, 76100, Israel

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

Glatiramer Acetate

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Ayala Pollack, MD

    Kaplan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayala Pollack, MD

CONTACT

972-8-9441353Ayala_P@clalit.org.il

Gennady Landa, MD

CONTACT

972-8-9441353doctor.landa@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 25, 2007

First Posted

April 27, 2007

Study Start

August 1, 2006

Study Completion

April 1, 2007

Last Updated

April 27, 2007

Record last verified: 2007-04

Locations

IL(1)