Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-31 @ 1:40 PM
Study NCT ID:
NCT06983704
Status:
COMPLETED
Last Update Posted:
2025-05-21
First Post:
2025-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Combined Bevacizumab-Mitomycin C Use During Ahmed Valve Revision in Recurrent Pediatric Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006871', 'term': 'Hydrophthalmos'}], 'ancestors': [{'id': 'D005124', 'term': 'Eye Abnormalities'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2025-05-14', 'studyFirstSubmitQcDate': '2025-05-14', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'surgical success', 'timeFrame': 'for 12 months', 'description': 'IOP ≤ 21 mmHg and ≥ 5 mmHg without medications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric glaucoma', 'Ahmed valve', 'bevacizumab', 'mitomycin C'], 'conditions': ['Pediatric Glaucoma']}, 'descriptionModule': {'briefSummary': 'To asess the efficacy and safety of combining subconjunctival bevacizumab with mitomycin C (MMC) during AGV revision surgery in pediatric patients with recurrent glaucoma.', 'detailedDescription': 'Recurrent pediatric glaucoma following Ahmed Glaucoma Valve (AGV) implantation presents a therapeutic challenge. This study evaluates the efficacy and safety of combining subconjunctival bevacizumab with mitomycin C (MMC) during AGV revision surgery in pediatric patients with recurrent glaucoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children under 12 years with previous AGV implantation for primary congenital glaucoma\n\nExclusion Criteria:\n\n* age \\>12 years, eyes with no light perception, and those with prior cyclodestructive procedures.'}, 'identificationModule': {'nctId': 'NCT06983704', 'acronym': 'MMC glaucoma', 'briefTitle': 'Assessing Combined Bevacizumab-Mitomycin C Use During Ahmed Valve Revision in Recurrent Pediatric Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Evaluation of Combined Bevacizumab-Mitomycin C Use During Ahmed Valve Revision in Recurrent Pediatric Glaucoma', 'orgStudyIdInfo': {'id': 'Bevacizumab-MMC'}, 'secondaryIdInfos': [{'id': 'Benha University', 'type': 'OTHER', 'domain': 'Al-Azhar University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I', 'description': 'subconjunctival injection of bevacizumab was administered around the AGV plate using a 27-gauge needle', 'interventionNames': ['Procedure: AGV plate', 'Procedure: bevacizumab injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II', 'description': 'AGV plate using a 27-gauge needle', 'interventionNames': ['Procedure: AGV plate']}], 'interventions': [{'name': 'AGV plate', 'type': 'PROCEDURE', 'description': 'AGV plate using a 27-gauge needle', 'armGroupLabels': ['Group I', 'Group II']}, {'name': 'bevacizumab injection', 'type': 'PROCEDURE', 'description': 'subconjunctival injection of bevacizumab', 'armGroupLabels': ['Group I']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Al-Azhar University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Ehab Mohamed Elsayed Mohamed Saad', 'investigatorAffiliation': 'Benha University'}}}}