Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-06-25 @ 1:41 AM
Study NCT ID:
NCT02527733
Status:
UNKNOWN
Last Update Posted:
2015-08-19
First Post:
2015-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retinal Sensitivity in BRVO After Anti-VEGF Therapy
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': 'D000069579', 'term': 'Ranibizumab'}, {'id': 'D007834', 'term': 'Lasers'}], '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'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'lastUpdateSubmitDate': '2015-08-17', 'studyFirstSubmitDate': '2015-06-29', 'studyFirstSubmitQcDate': '2015-08-17', 'lastUpdatePostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal sensitivity measured by microperimetry (MP-3, NIDEK, Japan)', 'timeFrame': 'At 12 months'}]}, 'conditionsModule': {'conditions': ['Branch Retinal Vein Occlusion']}, 'descriptionModule': {'briefSummary': 'The efficacy of anti-vascular endothelial growth factor (VEGF) therapy for branch retinal vein occlusion (BRVO) is shown, but its effect on retinal sensitivity is not fully investigated. The purpose of this study is to compare the changes in retinal sensitivity after ranibizumab therapy or combination therapy of ranibizumab and laser photocoagulation in eyes with BRVO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment naive patients of branch retinal vein occlusion with visual acuity of less than 1.0 and macular edema of more than 250 micrometers in foveal thickness.\n\nExclusion Criteria:\n\n* Patients with history of treatment for branch retinal vein occlusion, possibility of pregnancy, allergy for ranibizumab, intraocular infection, or severe inflammation will be excluded.'}, 'identificationModule': {'nctId': 'NCT02527733', 'briefTitle': 'Retinal Sensitivity in BRVO After Anti-VEGF Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Fukushima Medical University'}, 'officialTitle': 'Retinal Sensitivity in Branch Retinal Vein Occlusion After Anti-VEGF Therapy', 'orgStudyIdInfo': {'id': '2129'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ranibizumab', 'description': 'After initial single intravitreal injection of ranibizumab (0.5mg), participants receive monthly as-needed injection of ranibizumab (0.5mg) when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers.', 'interventionNames': ['Drug: Ranibizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ranibizumab and laser', 'description': 'After initial single intravitreal injection of ranibizumab (0.5mg), participants receive monthly as-needed injection of ranibizumab (0.5mg) when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers. Macular laser photocoagulation will be performed when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers.', 'interventionNames': ['Drug: Ranibizumab and laser']}], 'interventions': [{'name': 'Ranibizumab', 'type': 'DRUG', 'armGroupLabels': ['Ranibizumab']}, {'name': 'Ranibizumab and laser', 'type': 'DRUG', 'armGroupLabels': ['Ranibizumab and laser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9601295', 'city': 'Fukushima', 'state': 'Fukushima', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Akira Ojima, M.D., Ph.D', 'role': 'CONTACT', 'email': 'ao@fmu.ac.jp', 'phone': '+81-24-548-2111'}], 'facility': 'Department of Ophthalmology, Fukushima Medical University', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}], 'centralContacts': [{'name': 'Akira Ojima, M.D., Ph.D', 'role': 'CONTACT', 'email': 'ao@fmu.ac.jp', 'phone': '+81-24-548-2111'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fukushima Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Akira Ojima', 'investigatorAffiliation': 'Fukushima Medical University'}}}}