Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2026-06-16 @ 5:32 PM
Study NCT ID:
NCT01756261
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2012-12-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EYLEA [AMD-QOL(Age-Related Macular Degeneration-Quality of Life)] Post-marketing Surveillance in Japan
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': 'C533178', 'term': 'aflibercept'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 757}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2012-12-20', 'studyFirstSubmitQcDate': '2012-12-20', 'lastUpdatePostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in mean NEI-VFQ-25 overall scores of patients after the first intravitreal(ITV) injection of EYLEA', 'timeFrame': 'From baseline to 6 and 12 months'}], 'secondaryOutcomes': [{'measure': 'Changes in mean NEI-VFQ-25 subscale scores of patients after the first ITV injection of EYLEA', 'timeFrame': 'From baseline to 6 and 12 months'}, {'measure': 'Changes in mean NEI-VFQ-25 overall scores after the first ITV injection of EYLEA in subpopulations of patient background characteristics and status of EYLEA treatments, ie. Frequency, visual acuity, etc', 'timeFrame': 'From baseline to 6 and 12 months'}, {'measure': 'Changes in mean NEI-VFQ-25 subscale scores after the first ITV injection of EYLEA in subpopulations of patient background characteristics and status of EYLEA treatments, ie. Frequency, visual acuity, etc', 'timeFrame': 'From baseline to 6 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['EYLEA', 'Age-Related Macular Degeneration', 'QOL'], 'conditions': ['Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The objective of this survey is to evaluate effectiveness of EYLEA on Quality of Life (QOL). The QOL is evaluated by using Japanese version (v.1.4 - interviewer administered format) of National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) and compared at baseline and at the 6 and 12 months after start of EYLEA treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with subfoveal choroidal neovascular age-related macular degeneration', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have been determined to start EYLEA treatment\n* Patients who are registered to Special drug use investigation of EYLEA for AMD(Trial Number 15858)\n* Patients who have agreed with the patient informed consent\n\nExclusion Criteria:\n\n* Patients who have already received EYLEA'}, 'identificationModule': {'nctId': 'NCT01756261', 'briefTitle': 'EYLEA [AMD-QOL(Age-Related Macular Degeneration-Quality of Life)] Post-marketing Surveillance in Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Special Drug Use Investigation of EYLEA for Quality of Life', 'orgStudyIdInfo': {'id': '16656'}, 'secondaryIdInfos': [{'id': 'EYL-AMD-QOL', 'type': 'OTHER', 'domain': 'company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)']}], 'interventions': [{'name': 'Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)', 'type': 'DRUG', 'description': 'Patients treated with EYLEA under practical manner for AMD.', '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'}}}}