Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT00476918
Status:
UNKNOWN
Last Update Posted:
2007-05-22
First Post:
2007-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058449', 'term': 'Intravitreal Injections'}, {'id': 'D014222', 'term': 'Triamcinolone Acetonide'}], 'ancestors': [{'id': 'D056965', 'term': 'Injections, Intraocular'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2007-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-05-21', 'studyFirstSubmitDate': '2007-05-21', 'studyFirstSubmitQcDate': '2007-05-21', 'lastUpdatePostDateStruct': {'date': '2007-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity, no of treatments, duration of efficacy', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'intraocular pressure, retinal thickness', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetic macular edema', 'triamcinolone acetonide', 'intravitreal', 'steroid'], 'conditions': ['Diabetic Retinopathy', 'Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'Efficacy duration of triamcinolone acetonide (steroid) for treatment of diabetic macular edema. Furthermore, dosage dependency of triamcinolone acetonide comparing a high dosage versus a low dosage.', 'detailedDescription': 'Patients with diabetic retinopathy suffer from visual acuity loss caused by diabetic macular edema. Intravitreal injected Triamcinolone Acetonide (steroid) reduces macular edema and increases visual acuity. The duration of its effect is however limited. Therefore, several injections are necessary.\n\nIn this study a dosage dependency of triamcinolone acetonide (high dosage vs low dosage) is performed. The primary outcome parameters are the number of treatments and the efficacy of each injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetic macular edema and visual acuity between 20/200 and 20/40 age over 18 years\n\nExclusion Criteria:\n\n* recent treatment with laser photocoagulation or intravitreal drugs'}, 'identificationModule': {'nctId': 'NCT00476918', 'briefTitle': 'Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Dosage Dependency of Intravitreal Triamcinolone Acetonide for Treatment of Diabetic Macular Edema', 'orgStudyIdInfo': {'id': '21091968'}, 'secondaryIdInfos': [{'id': 'Insurance no.: 20-770-968594'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Intravitreal injection (triamcinolone acetonide)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '68167', 'city': 'Mannheim', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ulrich HM Spandau, PhD MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dep of Ophthalmology, University of Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], 'centralContacts': [{'name': 'Ulrich HM Spandau, PhD MD', 'role': 'CONTACT', 'email': 'ulrich.spandau@augen.ma.uni-heidelberg.de', 'phone': '+496213832242'}, {'name': 'Anne Wickenhaeuser, MD', 'role': 'CONTACT', 'email': 'anne.wickenhäuser@augen.ma.uni-heidelberg.de', 'phone': '+496213832242'}], 'overallOfficials': [{'name': 'Jost Jonas, PhD MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dep of Ophthalmology, University of Mannheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}}}}