Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT05337332
Status:
UNKNOWN
Last Update Posted:
2022-04-20
First Post:
2022-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Results of Suprachoroidal Steroids Injections in Two Chorioretinal Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056833', 'term': 'Central Serous Chorioretinopathy'}, {'id': 'D008269', 'term': 'Macular Edema'}, {'id': 'D015868', 'term': 'Pars Planitis'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D002833', 'term': 'Choroiditis'}, {'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D015866', 'term': 'Uveitis, Posterior'}, {'id': 'D015864', 'term': 'Panuveitis'}, {'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D015867', 'term': 'Uveitis, Intermediate'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014222', 'term': 'Triamcinolone Acetonide'}], 'ancestors': [{'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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2022-04-13', 'studyFirstSubmitQcDate': '2022-04-13', 'lastUpdatePostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Intraocular pressure', 'timeFrame': 'Baseline and 12 months after injection.', 'description': 'Changes in intraocular pressure (IOP) measured in millimeter mercury (mmHg) by applanation tonometry.'}], 'primaryOutcomes': [{'measure': 'Central macular thickness', 'timeFrame': 'Baseline and 12 months after injection.', 'description': 'Changes in central macular thickness (CMT) measured in millimeters (mm) by optical coherence tomography (OCT)'}], 'secondaryOutcomes': [{'measure': 'Best corrected visual acuity', 'timeFrame': 'Baseline and 12 months after injection.', 'description': 'Changes in best corrected visual acuity (BCVA) measured in logarithm of minimal angle of resolution (LogMAR) by chart projector.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Central serous chorioretinopathy', 'Cystoid macular edema'], 'conditions': ['Central Serous Chorioretinopathy', 'Irvine-Gass Syndrome', 'Pars Planitis', 'Cystoid Macular Edema']}, 'descriptionModule': {'briefSummary': 'Suprachoroidal injection is a safe way for intraocular drug delivery. It was used to treat various retinal conditions.', 'detailedDescription': 'Suprachoroidal triamcinolone acetonide injection is used to treat various retinal diseases, higher concentration of the injected material is found when the suprachoroidal space is used as an intraocular delivery pathway when compared to the conventional intravitreal pathway.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients diagnosed as central serous chorioretinopathy and patients with cystoid macular edema due to irvine-gass syndrome after cataract surgery.\n\nExclusion Criteria:\n\n* other retinal diseases that may affect CMT and final visual outcome.\n* Patients with dense corneal opacity.'}, 'identificationModule': {'nctId': 'NCT05337332', 'briefTitle': 'Results of Suprachoroidal Steroids Injections in Two Chorioretinal Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Suprachoroidal Triamcinolone Acetonide Injection in Two Chorioretinal Diseases: One Year Results', 'orgStudyIdInfo': {'id': 'RC 7-7-22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Central serous chorioretinopathy group', 'description': 'Cases with central serous chorioretinopathy (CSR) that will be injected with suprachoroidal triamcinolone acetonide.', 'interventionNames': ['Drug: Triamcinolone Acetonide']}, {'type': 'EXPERIMENTAL', 'label': 'Irvine-Gass Syndrome group', 'description': 'Cases with cystoid macular edema due to irvine-gass syndrome that will be injected with suprachoroidal triamcinolone acetonide', 'interventionNames': ['Drug: Triamcinolone Acetonide']}], 'interventions': [{'name': 'Triamcinolone Acetonide', 'type': 'DRUG', 'otherNames': ['Suprachoroidal triamcinolone acetonide injection (SCTA)'], 'description': 'Suprachoroidal injection of triamcinolone acetonide', 'armGroupLabels': ['Central serous chorioretinopathy group', 'Irvine-Gass Syndrome group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Banhā', 'state': 'QA', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Abdelshafy', 'role': 'CONTACT', 'email': 'ahmad4lg@gmail.com', 'phone': '01222328766'}], 'facility': 'Ahmed Abdelshafy', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'centralContacts': [{'name': 'Ahmed Abdelshafy, MD', 'role': 'CONTACT', 'email': 'ahmad4lg@gmail.com', 'phone': '01222328766'}, {'name': 'Marwa Abdelshafy, MD', 'role': 'CONTACT', 'email': 'ahmad4lg@gmail.com', 'phone': '01222328766'}], 'overallOfficials': [{'name': 'Ahmed A Abdelshafy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benha University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of Ophthalmology', 'investigatorFullName': 'Ahmed Abdelshafy', 'investigatorAffiliation': 'Benha University'}}}}