Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-25 @ 4:51 PM
Study NCT ID:
NCT00541333
Status:
SUSPENDED
Last Update Posted:
2013-05-03
First Post:
2007-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068717', 'term': 'Glatiramer Acetate'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'Reviewing data', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'lastUpdateSubmitDate': '2013-05-02', 'studyFirstSubmitDate': '2007-10-09', 'studyFirstSubmitQcDate': '2007-10-09', 'lastUpdatePostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total drusen area reduction', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dry Age Related Macular Degeneration', 'Dry AMD'], 'conditions': ['Dry Age Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Dry AMD in one or both eyes\n2. Age 50 or above of either gender\n3. Signed informed consent.\n\nExclusion Criteria:\n\n1. Known sensitivity to Mannitol or Copaxone.\n2. Skin disease or active infection of skin.\n3. Active fever or active treatment for infection.\n4. History of other uncontrolled systemic active disease.\n5. Premenopausal females not using reliable birth control.\n6. Sensitivity to fluorescein or iodine.\n7. Inability to comply with study procedures.'}, 'identificationModule': {'nctId': 'NCT00541333', 'briefTitle': 'Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-related Macular Degeneration', 'organization': {'class': 'OTHER', 'fullName': 'The New York Eye & Ear Infirmary'}, 'officialTitle': 'Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-related Macular Degeneration', 'orgStudyIdInfo': {'id': 'NYEE100907'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Copaxone', 'interventionNames': ['Drug: Copaxone Injection']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'interventionNames': ['Drug: Copaxone Injection']}], 'interventions': [{'name': 'Copaxone Injection', 'type': 'DRUG', 'armGroupLabels': ['Copaxone', 'Sham']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Eye and Ear Infirmary', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Richard B Rosen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Eye and Ear Infirmary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The New York Eye & Ear Infirmary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}