Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-25 @ 8:31 PM
Study NCT ID:
NCT02040220
Status:
COMPLETED
Last Update Posted:
2019-04-10
First Post:
2014-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Eylea for Central Retinal Vein Occlusion (CRVO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012170', 'term': 'Retinal Vein Occlusion'}, {'id': 'D008269', 'term': 'Macular Edema'}], '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'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533178', 'term': 'aflibercept'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 385}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-09', 'studyFirstSubmitDate': '2014-01-08', 'studyFirstSubmitQcDate': '2014-01-17', 'lastUpdatePostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of episodes of adverse drug reactions and adverse events(serious or non-serious, related or not related, ocular or non ocular)', 'timeFrame': '6 months after start of treatment with the drug'}], 'secondaryOutcomes': [{'measure': 'Effectiveness (visual acuity)', 'timeFrame': '6months after start of treatment with the drug'}, {'measure': 'Effectiveness (retina thickness)', 'timeFrame': '6months after start of treatment with the drug'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CRVO, Macular edema, Aflibercept, anti-VEGF'], 'conditions': ['Retinal Vein Occlusion']}, 'descriptionModule': {'briefSummary': 'This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of CRVO. The investigator will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert prior to enrolling the patient in this study.\n\nThe observation period for each patient starts when therapy with EYLEA is initiated. The enrollment period is 2 years. Patients will be followed for a time period of 2 years or until it is no longer possible (e.g. lost to follow-up) within the 2 years.\n\nFor each patient, data are collected as defined in the case report form at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice).\n\nThere will interim analysis of study data: 6 months after last patient first visit and J-PSUR(Japanese-Periodic Safety Update Report )'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female and male patients with a diagnosis of CRVO will be enrolled after the decision for treatment with EYLEA has been made by the investigator. Those patients prescribed EYLEA previously will not be included in this study. Physicians should consult the full prescribing information for EYLEA before enrolling patients and familiarize themselves with the safety information in the product package label. Eligible patients who receive EYLEA will be enrolled and documented in the eCRF.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who start EYLEA treatment for CRVO\n\nExclusion Criteria:\n\n* Patients who have already received EYLEA treatment\n* Patients who are contraindicated based on approved label'}, 'identificationModule': {'nctId': 'NCT02040220', 'acronym': 'JPMS-CRVO', 'briefTitle': 'Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Eylea for Central Retinal Vein Occlusion (CRVO)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Special Drug Use Investigation of EYLEA for CRVO', 'orgStudyIdInfo': {'id': '16641'}, 'secondaryIdInfos': [{'id': 'EYL-CRVO', 'type': 'OTHER', 'domain': 'company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Eylea treatment goup', 'interventionNames': ['Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)']}], 'interventions': [{'name': 'Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)', 'type': 'DRUG', 'description': '2 mg of Eylea will be treated per one injection at more than one months interval usually.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Japan'}], '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'}}}}