Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT05282420
Status:
UNKNOWN
Last Update Posted:
2022-03-16
First Post:
2022-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ranibizumab Versus Aflibercept for CRVO in Young Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008269', 'term': 'Macular Edema'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}, {'id': 'C533178', 'term': 'aflibercept'}], '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients were randomized into two groups, twenty patients (20 eyes) each. The first group received 0.5 mg\\\\0.1 ml ranibizumab intravitreal injections and the second group received 2.0 mg\\\\0.1 ml aflibercept intravitreal injections. all patients were followed up for at least 12 months.\n\nPatients were given the planned treatment throughout the study and no switching was done between anti-VEGF drugs'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-15', 'studyFirstSubmitDate': '2022-03-04', 'studyFirstSubmitQcDate': '2022-03-15', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best corrected visual acuity BCVA', 'timeFrame': 'at 12 months post-injection', 'description': 'change BCVA after injection'}], 'secondaryOutcomes': [{'measure': 'reduction of macular edema', 'timeFrame': 'at 12 months post-injection', 'description': 'change in central subfield macular thickness CST on OCT'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['non ischemic CRVO', 'Macular edema', 'Ranibizumab', 'Aflibercept'], 'conditions': ['Non-Ischemic Central Retinal Vein Occlusion With Macular Edema']}, 'descriptionModule': {'briefSummary': 'this study will compare the efficacy and safety of use either Ranibizumab and Aflibercept in treatment of macular edema resulting from non ischemic central retinal vein occlusion in patients younger than 5o years old', 'detailedDescription': 'This is a prospective randomized interventional study, Forty eyes of forty patients younger than 50 years with macular edema due to non-ischemic CRVO were enrolled in the study.\n\nPatients will be randomized into 2 groups. First group will receive intravitreal injection of Ranibizumab 0.5 mg\\\\0.1ml. the second group will receive intravitreal injection of 2.0 mg\\\\0.1 ml Aflibercept. All patients will be followed up for 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients younger than 50 years with macular edema due to non-ischemic CRVO\n\nExclusion Criteria: Other conditions that might affect the macula as\n\n1. diabetic retinopathy, intraocular inflammation, age related macular degeneration, patients with solar or radiation retinopathy,\n2. patients with ischemic type CRVO and patients who had recent intraocular surgery.\n3. patients who had previous intravitreal injections, ophthalmic laser surgeries.\n4. patients with dense cataracts whom fundus was difficult to scan.\n5. Patients who were lost to follow up visits were also excluded'}, 'identificationModule': {'nctId': 'NCT05282420', 'briefTitle': 'Ranibizumab Versus Aflibercept for CRVO in Young Patients.', 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': 'Ranibizumab Versus Aflibercept for Macular Edema Secondary to Non-ischemic Central Retinal Vein Occlusion in Young Adult Patients.', 'orgStudyIdInfo': {'id': 'SVU\\MED\\Oph026\\4\\21\\12\\284'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ranibizumab group', 'description': 'Ranibizumab injection monthly for 3 successive months', 'interventionNames': ['Procedure: intravitreal injection of Ranibizumab', 'Drug: Ranibizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aflibercept group', 'description': 'Aflibercept injection monthly for 3 successive months', 'interventionNames': ['Procedure: intravitreal injection of Aflipercept', 'Drug: Aflibercept']}], 'interventions': [{'name': 'intravitreal injection of Ranibizumab', 'type': 'PROCEDURE', 'description': 'intravitreal injection of Anti-VEGF Ranibizumab (Lucentis®; manufactured in the United States by Genentech/Roche)', 'armGroupLabels': ['Ranibizumab group']}, {'name': 'intravitreal injection of Aflipercept', 'type': 'PROCEDURE', 'description': 'intravitreal injection of Anti-VEGF Aflibercept (Eylea®; manufactured in the United States)', 'armGroupLabels': ['Aflibercept group']}, {'name': 'Ranibizumab', 'type': 'DRUG', 'description': 'Ranibizumab', 'armGroupLabels': ['Ranibizumab group']}, {'name': 'Aflibercept', 'type': 'DRUG', 'description': 'Aflipercept', 'armGroupLabels': ['Aflibercept group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83523', 'city': 'Qina', 'state': 'Qena Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed A Ahmed Amer, MD', 'role': 'CONTACT', 'email': 'AhmedAli.ophth@gmail.com', 'phone': '+201011827000'}], 'facility': 'Ahmed Ali Ahmed Amer', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ophthalmology department Qena Faculty of medicine, South Valley University, Egypt', 'investigatorFullName': 'Ahmed Ali Ahmed Amer', 'investigatorAffiliation': 'South Valley University'}}}}