Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2026-02-03 @ 12:39 AM
Study NCT ID:
NCT02120066
Status:
COMPLETED
Last Update Posted:
2014-04-22
First Post:
2014-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Submacular Hemorrhage Associated With Retinal Arterial Macro Aneurysm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014821', 'term': 'Vitrectomy'}], 'ancestors': [{'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-18', 'studyFirstSubmitDate': '2014-04-15', 'studyFirstSubmitQcDate': '2014-04-18', 'lastUpdatePostDateStruct': {'date': '2014-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Displacement of sub macular hemorrhage', 'timeFrame': 'one year', 'description': 'Anatomical recovery detected funduscopy and optical coherence tomography'}], 'secondaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': 'one year', 'description': 'Visual recovery after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Submacular hemorrhage', 'Vitrectomy', 'tissue- plasminogen activator'], 'conditions': ['Submacular Hemorrhage', 'Ruptured Retinal Arterial Macro Aneurysms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.eye-center.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of surgical outcome of vitrectomy with subretinal injection of recombinant tissue-plasminogen activator for submacular hemorrhage associated with retinal arterial macroanuerysms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients with sub macular hemorrhage associated with ruptured retinal arterial macro aneurysms\n\nExclusion Criteria:\n\n* The eyes with preretinal or intraretinal hemorrhage at the fovea\n* The patients with follow-up less than 3 months'}, 'identificationModule': {'nctId': 'NCT02120066', 'briefTitle': 'Submacular Hemorrhage Associated With Retinal Arterial Macro Aneurysm', 'organization': {'class': 'OTHER', 'fullName': 'Kyorin University'}, 'orgStudyIdInfo': {'id': 'Kyorineye015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Vitrectomy', 'interventionNames': ['Procedure: Vitrectomy for submacular hemorrhage', 'Drug: subretinal injection of tissue-plasminogen activator']}], 'interventions': [{'name': 'Vitrectomy for submacular hemorrhage', 'type': 'PROCEDURE', 'armGroupLabels': ['Vitrectomy']}, {'name': 'subretinal injection of tissue-plasminogen activator', 'type': 'DRUG', 'armGroupLabels': ['Vitrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '181-8611', 'city': 'Mitaka', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Kyorin Eye Center', 'geoPoint': {'lat': 35.68361, 'lon': 139.56002}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyorin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of Ophthalmology', 'investigatorFullName': 'Makoto Inoue', 'investigatorAffiliation': 'Kyorin University'}}}}