Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-27 @ 11:25 PM
Study NCT ID:
NCT00954057
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2009-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study to Determine Safety and Efficacy of Orbital Injections of LIPO-102 in Patients With Symptomatic Exophthalmos Associated With Thyroid-related Eye Disease (TED)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'dispFirstSubmitDate': '2015-03-05', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-05', 'studyFirstSubmitDate': '2009-08-04', 'dispFirstSubmitQcDate': '2015-03-05', 'studyFirstSubmitQcDate': '2009-08-05', 'dispFirstPostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: physical examinations, laboratory tests, VISA activity score, AE assessments', 'timeFrame': '8 weeks treatment and 1 week follow up'}], 'secondaryOutcomes': [{'measure': 'Efficacy: change in proptosis, VISA activity score, VAS for Eye Appearance Satisfaction', 'timeFrame': '8 weeks treatment and 1 week follow up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['TED'], 'conditions': ['Thyroid-Related Eye Disease']}, 'descriptionModule': {'briefSummary': 'This is a pilot study to determine the safety and efficacy of orbital injections of LIPO-102.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Non pregnant female\n* Symptomatic exophthalmos\n* Inactive Thyroid Eye Disease\n* Signed informed consent\n\nExclusion Criteria:\n\n* Known hypersensitivity to study drugs\n* Treatment with an investigational agent within 30 days of first dose\n* History of Thyroid Eye Disease less than 6 months\n* Previous decompression surgery\n* Glaucoma'}, 'identificationModule': {'nctId': 'NCT00954057', 'briefTitle': 'Pilot Study to Determine Safety and Efficacy of Orbital Injections of LIPO-102 in Patients With Symptomatic Exophthalmos Associated With Thyroid-related Eye Disease (TED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neothetics, Inc'}, 'officialTitle': 'A Single-masked, Placebo Controlled, Multi-center Pilot Study to Determine the Safety and Efficacy of Orbital Injections of a Fixed Dose of LIPO-102 in Patients With Symptomatic Exophthalmos Associated With Thyroid-related Eye Disease', 'orgStudyIdInfo': {'id': 'LIPO-102-CL-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LIPO-102', 'description': 'Intraorbital Injection', 'interventionNames': ['Drug: LIPO-102']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Intraorbital Injection', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LIPO-102', 'type': 'DRUG', 'description': 'intraorbital injection', 'armGroupLabels': ['LIPO-102']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'intraorbital injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adelaide', 'country': 'Australia', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Brisbane', 'country': 'Australia', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'city': 'Melbourne', 'country': 'Australia', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Sydney', 'country': 'Australia', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Auckland', 'country': 'New Zealand', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neothetics, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}