Ignite Creation Date:
2025-12-25 @ 3:14 AM
Ignite Modification Date:
2026-01-09 @ 7:10 AM
Study NCT ID:
NCT03598205
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2018-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-30', 'studyFirstSubmitDate': '2018-07-13', 'studyFirstSubmitQcDate': '2018-07-13', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean difference in CRT from baseline to 6 months', 'timeFrame': '6 months', 'description': 'To explore the effect of curcumin formulation in addition to intravitreal dexamethasone therapy on OCT central retinal thickness after 6 months of therapy'}], 'secondaryOutcomes': [{'measure': 'Mean difference in BCVA from baseline to 6 months', 'timeFrame': '6 months', 'description': 'To explore the effect of curcumin formulation in addition to intravitreal dexamethasone therapy on BCVA after 6 months of therapy'}, {'measure': 'Evaluation of safety: incidence of Treatment-Emergent Adverse Events', 'timeFrame': '6 months', 'description': 'To explore the safety of curcumin formulation (incidence of Treatment-Emergent Adverse Events ) in addition to intravitreal dexamethasone therapy after 6 months'}, {'measure': 'Retreatment times', 'timeFrame': '6 months', 'description': 'To explore the effect of curcumin formulation in addition to intravitreal dexamethasone therapy on retreatment times'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Therapy for diabetic macular edema', 'Curcumin formulation (DIABEC)'], 'conditions': ['Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to explore the effect of a curcumin formulation in combination to intravitreal dexamethasone therapy in patients with diabetic macular edema on morphological retinal characteristics and retreatment times.', 'detailedDescription': 'Patients with diagnosis of clinically significant diabetic macular edema, confirmed by fluorangiography and OCT, undergoing to intravitreal dexamethazone injection will be enrolled in the study.\n\nEnrollment will take place according to the inclusion/exclusion criteria set by the protocol.\n\nThe enrolled patients will be randomized for the addition or not of the curcumin formulation (2 tablets/die for 6 months) to intravitreal therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Patients with clinically significant diabetic macular edema in non-proliferative diabetic retinopathy, diagnosed by fluorangiography and OCT\n* Naive patients\n* Patients with clinically significant DME who have not been treated for more than 3 months with anti-VEGF therapy and for more than 6 months with intravitreal injection of dexamethasone\n* Central retinal thickness (CRT) at OCT\\> 300 microns\n* Best Corrected Visual Acuity (BCVA) with ETDRS tables at 4 meters not \\<20/400\n* Ability to provide written informed consent and follow the procedures of the study\n\nExclusion Criteria:\n\n* Retinal pathologies other than diabetic macular edema\n* Proliferative diabetic retinopathy\n* Opacities that limit the execution and interpretation of diagnostic tests\n* Surgical interventions in the study eye in the 3 months prior to the start of treatment\n* Pregnancy\n* Feeding time'}, 'identificationModule': {'nctId': 'NCT03598205', 'acronym': 'DIABEC', 'briefTitle': 'Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione G.B. Bietti, IRCCS'}, 'officialTitle': 'Combination Therapy Based on Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema Treatment to Help the Antiedemigenous Effect of Intravitreal Dexamethasone in Subjects With Diabetic Macular Edema (DME)', 'orgStudyIdInfo': {'id': 'FGBBietti'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DIABEC plus intravitreal dexamethazone', 'description': 'Intervention:Curmin formulation (DIABEC) plus dexamethazone intravitreal injection. Oral curcumin formulation (DIABEC 2 tablets/die) in combination with Dexamethazone (0,7 mg) intravitral injection for diabetic macular edema treatment', 'interventionNames': ['Combination Product: DIABEC plus intravitreal dexamethazone']}, {'type': 'NO_INTERVENTION', 'label': 'dexamethazone intravitreal injection', 'description': 'Intervention: dexamethazone intravitreal injection (0,7 mg) in PRN for diabetic macular edema treatment monotherapy.'}], 'interventions': [{'name': 'DIABEC plus intravitreal dexamethazone', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Intravitreal dexamethazone'], 'description': 'Patients with diabetic macular edema undergoing to intravitreal dexamethazone will be randomized to curcumin formulation (DIABEC)', 'armGroupLabels': ['DIABEC plus intravitreal dexamethazone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24125', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'Università Humanitas Gavazzeni Bergamo', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '88100', 'city': 'Catanzaro', 'country': 'Italy', 'facility': 'Università degli Studi Magna Graecia', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '00198', 'city': 'Rome', 'country': 'Italy', 'facility': 'Fondazione G.B.Bietti-IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Mariacristina Parravano', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione G.B. Bietti, IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione G.B. Bietti, IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD , Head RETINA UNIT', 'investigatorFullName': 'Mariacristina Parravano', 'investigatorAffiliation': 'Fondazione G.B. Bietti, IRCCS'}}}}