Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 7:42 PM
Study NCT ID:
NCT05345808
Status:
COMPLETED
Last Update Posted:
2022-04-26
First Post:
2022-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Formulated Posterior Sub Tenon Triamcinolone in Macular Edema Secondary to Non-Ischemic Retinal Vein Occlusions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012170', 'term': 'Retinal Vein Occlusion'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2022-04-14', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best corrected visual acuity', 'timeFrame': 'at the base line', 'description': 'Measured by snellen chart'}, {'measure': 'Best corrected visual acuity', 'timeFrame': 'at 1st month', 'description': 'Measured by snellen chart'}, {'measure': 'Best corrected visual acuity', 'timeFrame': 'at 3rd month', 'description': 'Measured by snellen chart'}, {'measure': 'Best corrected visual acuity', 'timeFrame': 'at 6th month', 'description': 'Measured by snellen chart'}, {'measure': 'Central macular thickness', 'timeFrame': 'at 1st month', 'description': 'Measured by Optical coherence tomography (OCT)'}, {'measure': 'Central macular thickness', 'timeFrame': 'at 3rd month', 'description': 'Measured by Optical coherence tomography (OCT)'}, {'measure': 'Central macular thickness', 'timeFrame': 'at 6th month', 'description': 'Measured by Optical coherence tomography (OCT)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Retinal Vein Occlusion']}, 'descriptionModule': {'briefSummary': 'Retinal vein occlusion (RVO) is considered the second vascular disorder of the retina after diabetic retinopathy. Patients with RVO are at risk of the development of macular edema. Different treatment modalities for macular edema include LASER therapy, antivascular endothelial growth factor (VEGF), and triamcinolone.\n\nAim To detect the efficacy of formulated Triamcinolone Acetonide(TA) injection in the posterior subtenon space to manage macular edema secondary to non-ischemic RVOs, either central or branch.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diminution of vision due to macular edema secondary to non-ischemic retinal vein occlusions, either central or branch\n* CMT ≥ 250 µ,\n* Willing to participate in the study.\n\nExclusion Criteria:\n\n* Unwilling to participate in the study\n* Ischemic RVO\n* previous laser treatment\n* Glaucoma, macular ischemia, cataract, vitreous hemorrhage, and neovascularization of the iris\n* patients with previous anti VEGFs or steroid injections or any eye surgery three months before the inclusion\n* Cardiac co-morbidities result in significant hemodynamic changes\n* Respiratory diseases need treatment with antibiotics\n* Suffering from other chronic diseases as diabetes\n* Patient with allergy from triamcinolone acetonide.'}, 'identificationModule': {'nctId': 'NCT05345808', 'briefTitle': 'Efficacy of Formulated Posterior Sub Tenon Triamcinolone in Macular Edema Secondary to Non-Ischemic Retinal Vein Occlusions', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Efficacy of Formulated Posterior Sub Tenon Triamcinolone in Macular Edema Secondary to Non-Ischemic Retinal Vein Occlusions', 'orgStudyIdInfo': {'id': 'PSTA in macular edema'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Formulated Posterior Sub Tenon Triamcinolone', 'description': 'All the eyes received single dose 40 mg of Triamcinolone Acetonide (TA) and VISCOAT which is 20 mg sodium chondroitin sulphate and 15 mg sodium hyaluronate (0.5 ml) through posterior subtenon route using NAGATA subtenon canula.', 'interventionNames': ['Drug: Triamcinolone Acetonide']}], 'interventions': [{'name': 'Triamcinolone Acetonide', 'type': 'DRUG', 'description': 'Triamcinolone Acetonide formulated with chondroitin sulfate and sodium hyaluronate', 'armGroupLabels': ['Formulated Posterior Sub Tenon Triamcinolone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34517', 'city': 'Damietta', 'country': 'Egypt', 'facility': 'Akram Fekry Elgazzar', 'geoPoint': {'lat': 31.41648, 'lon': 31.81332}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Akram Fekry Elgazzar', 'investigatorAffiliation': 'Al-Azhar University'}}}}