- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00466076
Copaxone in Age Related Macular Degeneration
Subcutaneous Copaxone as Treatment for Dry Age Related Macular Degeneration
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The formation of insoluble extracellular deposits consisting of misfolded, aggregated protein is the hallmark of many neurodegenerative diseases. Age-related macular degeneration (AMD) is a degenerative disease in the eye associated with extracellur deposits named drusen. Recent evidence suggests that drusen formation and AMD share some similarities with another neurodegenerative disease named Alzheimer's disease (AD) which is associated with amyloid deposits. AMD and AD are strongly correlated with advancing age and the formation of amyloid deposits. In addition, inflammatory mediators and in particular activated microglia are present in amyloid deposits as well as in drusen, suggesting a possible common role for the inflammatory pathway in AMD and amyloid diseases. Moreover, Ambati et al described a new model of AMD in transgenic mice when an absence of normally functioning macrophages led to the development of clinical AMD.
Michal Schwartz and her group have recently shown that aggregated b-amyloid (Ab) induces microglia to become cytotoxic and block neurogenesis from adult rodent neural progenitor cells (NPCs). IL-4, reversed the impediment, attenuated TNF-a production and overcame blockage of insulin like growth factor (IGF)-I production caused by Ab. The significance of microglia for in-vivo neural cell renewal was demonstrated by enhanced neurogenesis in the rat dentate gyrus after injection of IL-4-activated microglia intracerebroventricularly and by the presence of IGF-I-expressing microglia in the dentate gyrus of rats kept in an enriched environment or in the animal model of multiple sclerosis (MS). Using double-transgenic mice expressing mutant human genes encoding presenilin 1 and chimeric mouse/human amyloid precursor protein (mice Alzheimer's disease model), the group of Michal Schwartz showed that modulation of microglia into dendritic-like cells, achieved by a T cell-based vaccination with Copolymer-1 (Copaxone), resulted in reduction of cognitive decline, elimination of plaque formation, and induction of neuronal survival and neurogenesis. These results introduce a new microglia phenotype as necessary players in fighting off neurodegenerative conditions such as AD and AMD.
Study Type
Enrollment
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Ayala Pollack, MD
- Phone Number: 972-8-9441353
- Email: Ayala_P@clalit.org.il
Study Contact Backup
- Name: Gennady Landa, MD
- Phone Number: 972-8-9441353
- Email: doctor.landa@gmail.com
Study Locations
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-
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Rehovot, Israel, 76100
- Recruiting
- Department of Ophthalmology, Kaplan Medical Center
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Contact:
- Annat Pilpoul
- Phone Number: 972-8-9441691
- Email: apilpoul@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Dry AMD in both eyes
- Age 50 or above.
- 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 active disaese.
- Premenapausal females not using relibale birth control.
- Sensitivity for flourescein or iodine.
- Inability to comply with study procedures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Total drusen area reduction
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayala Pollack, MD, Kaplan Medical Center
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- kmc060033
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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