Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT01424735
Status:
COMPLETED
Last Update Posted:
2011-08-29
First Post:
2011-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TLR-9 Antagonism in Steroid Resistant Optic Neuritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009902', 'term': 'Optic Neuritis'}, {'id': 'D011681', 'term': 'Pupil Disorders'}], 'ancestors': [{'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625648', 'term': 'Immuvac'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-26', 'studyFirstSubmitDate': '2011-08-25', 'studyFirstSubmitQcDate': '2011-08-26', 'lastUpdatePostDateStruct': {'date': '2011-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in all aspects of visual function', 'timeFrame': 'upto 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Best corrected Visual Acuity', 'Pupillary Reaction', 'Colour vision', 'Disc edema'], 'conditions': ['Optic Neuritis']}, 'descriptionModule': {'briefSummary': 'Although idiopathic steroid resistant optic neuritis is very uncommon, there is no established treatment protocol for such patients. Toll like receptors (TLRs) especially TLR-9 has been shown to play a role in the pathogenesis of optic neuritis. This small case series aims to determine whether immunomodulators directed specifically at TLR-9(i.e. TLR-9 antagonism)play any role in improving the visual function in such patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nUnilateral Steroid Resistant Optic Neuritis\n\nExclusion Criteria:\n\n* bilateral optic neuritis\n* Associated Systemic disease\n* Prior treatment received'}, 'identificationModule': {'nctId': 'NCT01424735', 'briefTitle': 'TLR-9 Antagonism in Steroid Resistant Optic Neuritis', 'organization': {'class': 'OTHER', 'fullName': 'Sudhalkar Eye Hospital'}, 'officialTitle': 'Outcomes of TLR-9 Antagonism in Steroid Resistant Optic Neuritis; A Pilot Study', 'orgStudyIdInfo': {'id': '21234EH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mw.', 'description': 'Administration of immunomodulator Mw.', 'interventionNames': ['Drug: Mycobacterium w.(Mw)-freeze dried extract 0.5ml']}], 'interventions': [{'name': 'Mycobacterium w.(Mw)-freeze dried extract 0.5ml', 'type': 'DRUG', 'otherNames': ['IMMUVAC'], 'description': '0.5 ml of Mw in 500ml 0.9% normal saline administered over two hours as an infusion. 2ml(4mg/ml) of dexamethasone administered two hours prior to Mw administration', 'armGroupLabels': ['Mw.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '390001', 'city': 'Vadodara', 'state': 'Gujarat', 'country': 'India', 'facility': 'Sudhalkar Eye Hospital', 'geoPoint': {'lat': 22.29941, 'lon': 73.20812}}], 'overallOfficials': [{'name': 'Bakulesh M Khamar, M.S. Ophthalmology', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thakore Eye Hospital, Ahmedabad'}, {'name': 'Mayuri B Khamar, M.S.Ophthalmology', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M & J Institute Of Ophthalmology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sudhalkar Eye Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Aditya Sudhalkar', 'investigatorFullName': 'Aditya Sudhalkar', 'investigatorAffiliation': 'Sudhalkar Eye Hospital'}}}}