Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-03-04 @ 10:42 PM
Study NCT ID:
NCT02017808
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2013-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studying the Effects of Copaxone on Retinal Health Using Optical Tomography Over 24 Months
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-01', 'studyFirstSubmitDate': '2013-12-04', 'studyFirstSubmitQcDate': '2013-12-20', 'lastUpdatePostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal health in multiple sclerosis patients prescribed copaxone', 'timeFrame': '24 months', 'description': 'Participants will have an OCT retinal health will be determined by degree of axonal loss.'}], 'secondaryOutcomes': [{'measure': 'Measuring disability progression', 'timeFrame': '24 months', 'description': 'Investigating the effect of copaxone on total macular volume on OCT in patients with RRMS. Exploring progression of disability as measured by Expanded Disability Status Scale (EDSS).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['OCT', 'Copaxone', 'Multiple sclerosis', 'relapsing-remitting'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This is a prospective, observational, single-blinded, longitudinal, 24-month OCT study of the evolution of axonal loss, as evidenced by loss of RNFLT and TMV, in RRMS patients treated with GA and in healthy controls.', 'detailedDescription': 'The primary aim of this study is to explore whether treatment with Copaxone may decrease accumulation of axonal loss, as measured by retinal nerve fiber layer thickness (RNFLT) on optical coherence tomography (OCT) in patients with RRMS over 24 months and compared to a reference population of healthy controls.\n\nThe secondary objective of this study is to investigate the effect of GA on total macular volume (TMV) on OCT in patients with RRMS over 24 months. We will also explore how the 24-month changes of RNFLT and TMV on OCT relate to progression of disability, as measured by Expanded Disability Status Scale (EDSS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with relapsing remitting multiple sclerosis Healthy controls without known neurological problems.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MS patients diagnosed with clinically definite MS according to the McDonald criteria (Polman et al., 2005)\n* Starting GA monotherapy (20mg/day sc) at the time of the OCT scan\n* Having baseline clinical OCT scan that included RNFLT and TMV assessment at the start of the GA\n* Having baseline clinical OCT scan that included RNFLT and TMV assessment (healthy controls)\n* MS patients having a RR disease course (Lublin and Reingold, 1996)\n* Age 18-65 (healthy controls will be matched to MS patients for age and sex)\n* Signed informed consent at the 24-month follow-up\n* None of the exclusion criteria\n\nExclusion Criteria:\n\n* Patients who had a relapse within 30 days prior to OCT scan date\n* Patients who received steroid treatment within 30 days prior to OCT scan date\n* Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study\n* MS patients who used other imunomodulatory or immunosuppressant treatment other than GA during the follow-up (e.g., IFN-β, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)'}, 'identificationModule': {'nctId': 'NCT02017808', 'acronym': 'GAO', 'briefTitle': 'Studying the Effects of Copaxone on Retinal Health Using Optical Tomography Over 24 Months', 'organization': {'class': 'OTHER', 'fullName': 'University at Buffalo'}, 'officialTitle': 'A Prospective, Observational, Single-blinded, Longitudinal Optical Coherence Tomography Study of Effect of Copaxone (Glatiramer Acetate) on Retinal Nerve Fiber Layer Thickness in Patients With Relapsing-remitting Multiple Sclerosis Over 24 Months', 'orgStudyIdInfo': {'id': 'GA-OCT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Copaxone', 'description': 'Patients with multiple sclerosis who are currently prescribed glatiramer acitate (Copaxone)'}, {'label': 'OCT', 'description': 'Healthy controls'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Buffalo Neuroimaging Analysis Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Robert Zivadinov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SUNY University at Buffalo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University at Buffalo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Teva Pharmaceuticals USA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Buffalo Neuroimaging Analysis Center, Professor', 'investigatorFullName': 'Robert Zivadinov, MD, PhD', 'investigatorAffiliation': 'University at Buffalo'}}}}