Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:09 PM
Study NCT ID:
NCT04882956
Status:
UNKNOWN
Last Update Posted:
2021-05-12
First Post:
2021-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BEOVU Versus Eylea in the Treatment of Age-related Macular Neovascular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058449', 'term': 'Intravitreal Injections'}, {'id': 'C533178', 'term': 'aflibercept'}], 'ancestors': [{'id': 'D056965', 'term': 'Injections, Intraocular'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-11', 'studyFirstSubmitDate': '2021-05-06', 'studyFirstSubmitQcDate': '2021-05-11', 'lastUpdatePostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best corrected visual acuity (BCVA)', 'timeFrame': '12 months', 'description': 'Change in BCVA in LOG MARS(logarithm minimum angle of resolution'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['macular degeneration', 'BEOVU', 'Eylea'], 'conditions': ['Macula Lutea Degeneration']}, 'descriptionModule': {'briefSummary': 'Age-Related macular neovascularization degeneration occur is a vision threatening condition. The investigators compare the efficacy of BEOVU and Eylea intravitreal treatment in the management.', 'detailedDescription': 'Baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination was done. Procedure included randomized intravitreal injection of Brolucizumab (BEOVU®, Genentech, South Francisco, CA) and of aflibercept (Eylea; Regeneron, Tarrytown,NY)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Age-Related macular neovascularization degeneration\n\nExclusion Criteria:\n\n* other causes of macular neovascularization degeneration\n* other macular diseases'}, 'identificationModule': {'nctId': 'NCT04882956', 'briefTitle': 'BEOVU Versus Eylea in the Treatment of Age-related Macular Neovascular Degeneration', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Outcome of Brolucizumab-dbll and Aflibercept Intravitreal Injection in the Treatment of Age-related Macular Neovascular Degeneration', 'orgStudyIdInfo': {'id': 'Hamaky11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BEOVU', 'description': 'Intravitreal injection of BEOVU 3 loading injections ( monthly) then every 3 months', 'interventionNames': ['Drug: intravitreal injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Eylea', 'description': 'Intravitreal injection of Eylea 3 loading injections ( monthly) then every 3 months', 'interventionNames': ['Drug: intravitreal injection']}], 'interventions': [{'name': 'intravitreal injection', 'type': 'DRUG', 'otherNames': ['BEOVU'], 'description': 'Brolucizumab-Dbll intravitreal injection', 'armGroupLabels': ['BEOVU']}, {'name': 'intravitreal injection', 'type': 'DRUG', 'otherNames': ['Eylea'], 'description': 'Aflipercept intravitreal injection', 'armGroupLabels': ['Eylea']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46266', 'city': 'Abu Dhabi', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'name': 'TAREK R ELHAMAKY, MD', 'role': 'CONTACT'}], 'facility': 'INMC', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], 'centralContacts': [{'name': 'Tarek R Elhamaky, MD', 'role': 'CONTACT', 'email': 'thamaky@ibnnafees.com', 'phone': '+97126324200'}, {'name': 'Tarek Elhamaky, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Tarek Elhamaky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benha University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'unlimited', 'ipdSharing': 'YES', 'description': 'by direct contact through email', 'accessCriteria': 'direct request by email'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor (associate)', 'investigatorFullName': 'Tarek Roshdy mohamed Mahgoub ELhamaky', 'investigatorAffiliation': 'Benha University'}}}}