Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-27 @ 9:56 AM
Study NCT ID:
NCT05429450
Status:
COMPLETED
Last Update Posted:
2022-09-21
First Post:
2022-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thyroid Associated Orbitopathy Treatment by Methotrexate Against Triamcinolone Periocular Injections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D014222', 'term': 'Triamcinolone Acetonide'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-17', 'studyFirstSubmitDate': '2022-06-18', 'studyFirstSubmitQcDate': '2022-06-18', 'lastUpdatePostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in clinical activity score (CAS)', 'timeFrame': '2 weeks, 1 month, 3 months and 6 months', 'description': 'Mean change in clinical activity score from baseline. CAS is a 10-point score (0-10) with disease considered active if CAS is \\>3.'}], 'secondaryOutcomes': [{'measure': 'Change in proptosis', 'timeFrame': '2 weeks, 1 month, 3 months and 6 months', 'description': 'Mean change in proptosis measured in millimeters by an exopthalmometer compared to baseline proptosis'}, {'measure': 'Change in lid aperture', 'timeFrame': '2 weeks, 1 month, 3 months and 6 months', 'description': 'Mean change in lid aperture (distance between upper and lower lid margin measured in millimeters by a ruler'}, {'measure': 'Percentage of overall responders', 'timeFrame': '3 months and 6 months', 'description': 'A participant is considered an overall responder if 2 or more of the following:\n\n1. Improvement of CAS ≥ 2 points.\n2. Improvement of proptosis ≥ 2 mm.\n3. Improvement of lid aperture ≥ 2 mm.\n4. Improvement of soft tissue signs ≥ 1 grade\n5. Improvement of EOM ductions'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thyroid associated orbitopathy', "Grave's orbitopathy", 'Periocular injections', 'Methotrexate', 'Triamcinolone'], 'conditions': ['Thyroid Associated Orbitopathy']}, 'descriptionModule': {'briefSummary': 'The study objective is to investigate the efficacy and safety of periocular injections of methotrexate in management of patients with active moderate to severe thyroid associated orbitopathy in comparison to periocular injections of triamcinolone acetonide.', 'detailedDescription': 'Recruited subjects will be randomized such that one orbit receives 3 periocular injections of methotrexate and the contralateral orbit receives 3 periocular injections of triamcinolone acetonide at day 0, week 3 and week 6. All study subjects will be followed up for 6 months where outcome measures are assessed at 2 weeks, 1month, 3 months and 6 months after last injection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Bilateral moderate to severe thyroid associated orbitopathy.\n2. Clinical Activity score (CAS) ≥ 3.\n3. Duration of thyroid associated orbitopathy \\< 2 years\n\nExclusion Criteria:\n\n1. Sight threatening thyroid associated orbitopathy (dysthyroid optic neuropathy or exposure keratopathy) in any eye.\n2. Glaucoma patients or those known to be steroid responders\n3. Presence of orbital infections or any infection in nearby structures as paranasal sinusitis or dental abscess\n4. Pregnancy\n5. Previous orbital or lid surgeries\n6. History of steroid therapy (oral, intravenous or periocular) or other immunosuppressive therapy within the previous 3 months'}, 'identificationModule': {'nctId': 'NCT05429450', 'acronym': 'TOMATO', 'briefTitle': 'Thyroid Associated Orbitopathy Treatment by Methotrexate Against Triamcinolone Periocular Injections', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparative Study on the Efficacy of Periocular Methotrexate Versus Periocular Triamcinolone Injections in Management of Thyroid Associated Orbitopathy', 'orgStudyIdInfo': {'id': 'MD-139-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methotrexate', 'description': 'Periocular injections of methotrexate', 'interventionNames': ['Drug: Methotrexate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Triamcinolone acetonide', 'description': 'Periocular injections of triamcinolone acetonide', 'interventionNames': ['Drug: Triamcinolone Acetonide']}], 'interventions': [{'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Three periocular injections of methotrexate at week 0, week 3 and week 6.', 'armGroupLabels': ['Methotrexate']}, {'name': 'Triamcinolone Acetonide', 'type': 'DRUG', 'description': 'Three periocular injections of triamcinolone acetonide at week 0, week 3 and week 6.', 'armGroupLabels': ['Triamcinolone acetonide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Haytham E. Nasr', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}, {'name': 'Rania A. El Essawy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Kareem B. Elessawy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Islam Y. Swaify', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Islam Youssef Swaify', 'investigatorAffiliation': 'Cairo University'}}}}