Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-27 @ 12:23 AM
Study NCT ID:
NCT01512966
Status:
COMPLETED
Last Update Posted:
2014-10-09
First Post:
2012-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Japanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema)
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': 'C533178', 'term': 'aflibercept'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-08', 'studyFirstSubmitDate': '2012-01-16', 'studyFirstSubmitQcDate': '2012-01-16', 'lastUpdatePostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Event collection', 'timeFrame': 'Week 52'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in BCVA (best corrected visual acuity) letter score', 'timeFrame': 'Week 52'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetic Macular Edema', 'DME', 'VEGF Trap-Eye', 'best-corrected visual acuity (BCVA)'], 'conditions': ['Macular Edema']}, 'descriptionModule': {'briefSummary': 'This study will assess the safety and tolerability of intravitreally (IVT) administered VEGF Trap-Eye in Japanese subjects with diabetic macular edema (DME) over the period of one year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥ 18 years with type 1 or 2 diabetes mellitus\n* Subjects with DME (diabetic macular edema) secondary to diabetes mellitus involving the center of the macula in the study eye\n* BCVA (best-corrected visual acuity) ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 24 (20/40 to 20/320) in the study eye\n\nExclusion Criteria:\n\n* Active proliferative diabetic retinopathy (PDR) in the study eye\n* Uncontrolled diabetes mellitus, as defined by HbA1c \\>12%\n* Only 1 functional eye even if that eye is otherwise eligible for the study'}, 'identificationModule': {'nctId': 'NCT01512966', 'acronym': 'VIVID-Japan', 'briefTitle': 'Japanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'An Open-label Phase III Study Evaluating the Safety and Tolerability of Repeated Doses of Intravitreal VEGF Trap-Eye in Japanese Subjects With Diabetic Macular Edema', 'orgStudyIdInfo': {'id': '15657'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VTE 2Q4 first, then VTE 2Q8', 'description': 'VEGF Trap-Eye \\[BAY86-5321; EYLEA (aflibercept) Injection\\] 2 mg Q4 (VTE 2Q4) administered every 4 weeks from Week 0 to Week 16, followed by every 8 weeks until Week 48 (2Q8)', 'interventionNames': ['Biological: VEGF Trap-Eye (BAY86-5321)']}], 'interventions': [{'name': 'VEGF Trap-Eye (BAY86-5321)', 'type': 'BIOLOGICAL', 'description': 'Subjects in the VEGF Trap-Eye group will receive intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks. The overall treatment period is 48 weeks.', 'armGroupLabels': ['VTE 2Q4 first, then VTE 2Q8']}]}, 'contactsLocationsModule': {'locations': [{'zip': '790-8524', 'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'zip': '371-8511', 'city': 'Maebashi', 'state': 'Gunma', 'country': 'Japan', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'zip': '650-0017', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '310-0015', 'city': 'Mito', 'state': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 36.35, 'lon': 140.45}}, {'zip': '761-0793', 'city': 'Kita', 'state': 'Kagawa-ken', 'country': 'Japan'}, {'zip': '890-8520', 'city': 'Kagoshima', 'state': 'Kagoshima-ken', 'country': 'Japan', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '216-8511', 'city': 'Kawasaki', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'zip': '606-8507', 'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '984-8560', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '634-8522', 'city': 'Kashihara', 'state': 'Nara', 'country': 'Japan', 'geoPoint': {'lat': 33.95, 'lon': 135.78333}}, {'zip': '700-8558', 'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '537-0025', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '558-8558', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '565-0871', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '840-8571', 'city': 'Saga', 'state': 'Saga-ken', 'country': 'Japan', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'zip': '520-2192', 'city': 'Ōtsu', 'state': 'Shiga', 'country': 'Japan', 'geoPoint': {'lat': 35.0, 'lon': 135.86667}}, {'zip': '329-0498', 'city': 'Shimotsuke', 'state': 'Tochigi', 'country': 'Japan', 'geoPoint': {'lat': 36.41323, 'lon': 139.86622}}, {'zip': '641-8510', 'city': 'Wakayama', 'state': 'Wakayama', 'country': 'Japan', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}