Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-01-04 @ 2:38 PM
Study NCT ID:
NCT05484050
Status:
UNKNOWN
Last Update Posted:
2022-08-02
First Post:
2022-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VEGF in Iris Tissue in Primary Congenital Glaucoma
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': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-29', 'studyFirstSubmitDate': '2022-07-22', 'studyFirstSubmitQcDate': '2022-07-29', 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VEGF', 'timeFrame': '6 month', 'description': 'Estimation of VEGF grade in iris tissue through Immunohistochemistry, The grades is arranged from 0 to 5, with 0 being the lowest level and 5 being the highest level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iris']}, 'descriptionModule': {'briefSummary': 'Estimation of vascular endothelial growth factor (VEGF) in iris tissue specimen in primary congenital glaucoma through Immunohistochemistry.', 'detailedDescription': 'Combined trabeculotomy with mitomycin C will done in infants with primary congenital glaucoma with histopathological examination of the the peripheral iris tissue specimen and vascular endothelial growth factor (VEGF) estimation in iris tissue specimen through Immunohistochemistry.\n\nEstimation of vascular endothelial growth factor (VEGF) in iris tissue specimen taking from ocular trauma or congenital cataract used as control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary congenital glaucoma\n\nExclusion Criteria:\n\n* Infants with history of previous surgery.\n* Secondary glaucoma.\n* Glaucoma associated with other congenital anomalies.'}, 'identificationModule': {'nctId': 'NCT05484050', 'briefTitle': 'VEGF in Iris Tissue in Primary Congenital Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Estimation of Vascular Endothelial Growth Factor (VEGF) in Iris Tissue in Primary Congenital Glaucoma', 'orgStudyIdInfo': {'id': '2323300'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'VEGF in iris tissue in primary congenital glaucoma', 'description': 'Estimation of VEGF grade in iris tissue in primary congenital glaucoma through Immunohistochemistry', 'interventionNames': ['Other: Immunohistochemistry analysis']}, {'type': 'OTHER', 'label': 'VEGF in iris tissue from ocular trauma or congenital cataract', 'description': 'Estimation of VEGF grade in iris tissue from ocular trauma or congenital cataract through Immunohistochemistry', 'interventionNames': ['Other: Immunohistochemistry analysis']}], 'interventions': [{'name': 'Immunohistochemistry analysis', 'type': 'OTHER', 'description': 'Estimation of VEGF through Immunohistochemistry', 'armGroupLabels': ['VEGF in iris tissue from ocular trauma or congenital cataract', 'VEGF in iris tissue in primary congenital glaucoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7111', 'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'Hassan Lotfy, prof.', 'role': 'CONTACT', 'email': 'hassaniron57@yahoo.com', 'phone': '01020833002'}], 'facility': 'Hassan Lotfy', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hassan Lotfy Fahmy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hassan Lotfy Fahmy', 'investigatorAffiliation': 'Assiut University'}}}}