Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-01-01 @ 6:35 PM
Study NCT ID:
NCT05288192
Status:
UNKNOWN
Last Update Posted:
2022-03-21
First Post:
2022-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes After Suprachoroidal Injection.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D008269', 'term': 'Macular Edema'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-11', 'studyFirstSubmitDate': '2022-03-11', 'studyFirstSubmitQcDate': '2022-03-11', 'lastUpdatePostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in visual acuity', 'timeFrame': 'Monthly after injection till six months of follow up', 'description': 'Changes in best corrected visual acuity after injection'}, {'measure': 'Changes in central foveal thickness', 'timeFrame': 'Monthly after injection till six months of follow up', 'description': 'Changes in central macular thickness after injection'}], 'secondaryOutcomes': [{'measure': 'Changes in intraocular pressure', 'timeFrame': 'Monthly after injection till six months of follow up', 'description': 'Changes in intraocular pressure after injection'}, {'measure': 'Changes in lens', 'timeFrame': 'Monthly after injection till six months of follow up', 'description': 'Cataract progression after injection'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Retina; Change', 'Intraocular Pressure', 'Cataract', 'Macular Edema']}, 'descriptionModule': {'briefSummary': 'Changes after suprachoroidal injection are analyzed for statistical analysis.', 'detailedDescription': 'Changes after suprachoroidal injection of triamcinolone acetonide are noted in various retinal diseases treated by this technique to address its effects over six months of follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients prepared to suprachoroidal injection for various retinal diseases will be enrolled in the study.\n* Bilateral retinal diseases that required interventions as diabetic macular edema, exudative retinal detachment, and serous chorioretinopathies.\n\nExclusion Criteria:\n\n* Other retinal diseases that are not expected to improve after steroid injections as central retinal artery occlusion and age-related macular degenerations.\n* Choroidal neovascularization that require anti-vascular endothelial growth factors.\n* Patients refused to have steroid injections even after discussing the nature of their disease with them and the procedure to be done.'}, 'identificationModule': {'nctId': 'NCT05288192', 'briefTitle': 'Changes After Suprachoroidal Injection.', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Changes Noted After Suprachoroidal Triamcinolone Acetonide Injection.', 'orgStudyIdInfo': {'id': 'Rc-3-22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Suprachoroidal triamcinolone injection', 'description': 'Eyes treated with suprachoroidal injection of triamcinolone acetonide.', 'interventionNames': ['Drug: Suprachoroidal triamcinolone acetonide (SCTA) injection']}, {'type': 'NO_INTERVENTION', 'label': 'Non-treated eyes', 'description': 'Eyes that are receiving no interventions during the study period.'}], 'interventions': [{'name': 'Suprachoroidal triamcinolone acetonide (SCTA) injection', 'type': 'DRUG', 'otherNames': ['SCTA injection'], 'description': 'Suprachoroidal injection of 4mg/0.1ml of triamcinolone acetonide.', 'armGroupLabels': ['Suprachoroidal triamcinolone injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Banhā', 'state': 'QA', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Abdelshafy, MD', 'role': 'CONTACT', 'email': 'ahmad4lg@gmail.com', 'phone': '01222328766'}, {'role': 'CONTACT', 'email': 'ahmad4lg@gmail.com', 'phoneExt': 'Abdelshafy'}, {'name': 'Ahmed Abdelshafy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marwa Abdelshafy, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Benha University', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'centralContacts': [{'name': 'Ahmed Abdelshafy', 'role': 'CONTACT', 'email': 'ahmad4lg@gmail.com', 'phone': '01222328766'}], 'overallOfficials': [{'name': 'Ahmed A Tabl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benha University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Ophthalmology', 'investigatorFullName': 'Ahmed Abdelshafy', 'investigatorAffiliation': 'Benha University'}}}}