Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-01 @ 5:28 PM
Study NCT ID:
NCT06882551
Status:
COMPLETED
Last Update Posted:
2025-03-18
First Post:
2024-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Intravitreal Bevacizumab Injection with Combination of Suprachoroidal Triamcinolone Acetonide Along with Intravitreal Bevacizumab Injection in the Treatment of Diabetic Macular Edema in Pseudophakic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-16', 'studyFirstSubmitDate': '2024-11-10', 'studyFirstSubmitQcDate': '2025-03-16', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central macular thickness', 'timeFrame': '3 months', 'description': 'Effect of both treatment on central macular thickness measure on optical coherence tomography'}, {'measure': 'Visual Acuity', 'timeFrame': '3 months', 'description': 'Improvement in best corrected visual acuity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intravitreal bevacizumab', 'suprachoroidal triamcinolone', 'diabetic macular edema'], 'conditions': ['Diabetic Macular Edema (DME)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/36707790/', 'label': 'Suprachoroidal injection of triamcinolone acetonide plus intravitreal bevacizumab in diabetic macular edema: a randomized pilot trial'}]}, 'descriptionModule': {'briefSummary': 'Patients were included in the study who were pseudophakic with center-involved (sub-foveal) diabetic macular edema', 'detailedDescription': 'Patients were included in the study who were pseudophakic with center-involved (sub-foveal) diabetic macular edema. Those patients who had glaucoma history or IOP above 21 mm of Hg, Phakic, corneal opacity, vitreous hemorrhage, proliferative diabetic retinopathy, already received anti-VEGF injections, history of pan-retinal photocoagulation for proliferative diabetic retinopathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '32 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with center involving diabetic macular edema on optical coherence tomography\n\nExclusion Criteria:\n\n* Raised intraocular pressure\n* History of glaucoma\n* Corneal opacity\n* Vitreous hemorrhage\n* Proliferative diabetic retinopathy\n* Anti-VEGF injections in last 3 months\n* History of pan-retinal photocoagulation\n* Contraindications for anti-VEGF'}, 'identificationModule': {'nctId': 'NCT06882551', 'briefTitle': 'Comparison of Intravitreal Bevacizumab Injection with Combination of Suprachoroidal Triamcinolone Acetonide Along with Intravitreal Bevacizumab Injection in the Treatment of Diabetic Macular Edema in Pseudophakic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Khyber Teaching Hospital'}, 'officialTitle': 'Comparison of Intravitreal Bevacizumab Injection with Combination of Suprachoroidal Triamcinolone Acetonide Along with Intravitreal Bevacizumab Injection in the Treatment of Diabetic Macular Edema in Pseudophakic Patients', 'orgStudyIdInfo': {'id': 'KhyberTeH'}, 'secondaryIdInfos': [{'id': '450/DME/KMC', 'type': 'OTHER', 'domain': 'Instititional Ethical and Review Board (IERB)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravitreal Bevacizumab alone for center involving diabetic macular edema', 'description': 'Effect of intravitreal Bevacizumab 1.25mg on center involving diabetic macular edema', 'interventionNames': ['Drug: Intravitreal Bevacizumab IVB']}, {'type': 'EXPERIMENTAL', 'label': 'Suprachoroidal triamcinolone acetonide and intravitreal Bevacizumab', 'description': 'Combination of suprachoroidal triamcinolone acetonide and intravitreal Bevacizumab for the treatment of diabetic macular edema', 'interventionNames': ['Drug: intravitreal bevacizumab and suprachoroidal triamcinolone acetonide']}], 'interventions': [{'name': 'Intravitreal Bevacizumab IVB', 'type': 'DRUG', 'description': 'Intravitreal bevacizumab alone', 'armGroupLabels': ['Intravitreal Bevacizumab alone for center involving diabetic macular edema']}, {'name': 'intravitreal bevacizumab and suprachoroidal triamcinolone acetonide', 'type': 'DRUG', 'description': 'Combination of Intravitreal bevacizumab and suprachoroidal triamcinolone acetonide', 'armGroupLabels': ['Suprachoroidal triamcinolone acetonide and intravitreal Bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Peshawar', 'state': 'Khyber Pakhtunkhwa', 'country': 'Pakistan', 'facility': 'Khyber Teaching Hospital', 'geoPoint': {'lat': 34.008, 'lon': 71.57849}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khyber Teaching Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Ophthalmology', 'investigatorFullName': 'Imran Ahmad', 'investigatorAffiliation': 'Khyber Teaching Hospital'}}}}