Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2025-12-28 @ 6:08 AM
Study NCT ID:
NCT05791695
Status:
COMPLETED
Last Update Posted:
2023-12-01
First Post:
2023-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Incidence of Intraocular Inflammation and Suspected Endophthalmitis Among Patients Treated With Aflibercept, Vial and Pre-filled Syringe, 2014-2022
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}, {'id': 'D009877', 'term': 'Endophthalmitis'}, {'id': 'D012170', 'term': 'Retinal Vein Occlusion'}], 'ancestors': [{'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155413}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-30', 'studyFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2023-03-28', 'lastUpdatePostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of patients receiving aflibercept injections', 'timeFrame': 'End of Study, Approximately 8 Years'}, {'measure': 'Frequency of aflibercept injections by ophthalmic delivery mechanism', 'timeFrame': 'End of Study, Approximately 8 Years', 'description': 'Ophthalmic delivery mechanism defined as prefilled syringe (PFS) and vial'}, {'measure': 'Incidence of Intraocular inflammation (IOI)', 'timeFrame': 'End of Study, Approximately 8 Years', 'description': 'Incidence will be defined as the number of events during the at-risk period divided by the total number of injections, identified using international classification of diseases (ICD-9 and ICD-10) diagnosis codes.'}, {'measure': 'Incidence of Intraocular inflammation (IOI) by ophthalmic delivery mechanism', 'timeFrame': 'End of Study, Approximately 8 Years', 'description': 'Incidence will be defined as the number of events during the at-risk period divided by the total number of injections, identified using international classification of diseases (ICD-9 and ICD-10) diagnosis codes.\n\nOphthalmic delivery mechanism defined as prefilled syringe (PFS) and vial'}, {'measure': 'Incidence of suspected endophthalmitis', 'timeFrame': 'End of Study, Approximately 8 Years', 'description': 'Incidence will be defined as the number of events during the at-risk period divided by the total number of injections, identified using international classification of diseases (ICD-9 and ICD-10) diagnosis codes.'}, {'measure': 'Incidence of suspected endophthalmitis by ophthalmic delivery mechanism', 'timeFrame': 'End of Study, Approximately 8 Years', 'description': 'Incidence will be defined as the number of events during the at-risk period divided by the total number of injections, identified using international classification of diseases (ICD-9 and ICD-10) diagnosis codes.\n\nOphthalmic delivery mechanism defined as prefilled syringe (PFS) and vial'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Age-related macular degeneration', 'Anti-vascular endothelial growth factor', 'Diabetic macular edema', 'Diabetic retinopathy', 'Endophthalmitis', 'Intraocular inflammation', 'Retinal vein occlusion', 'Vascular endothelial growth factor'], 'conditions': ['Intraocular Inflammation', 'Suspected Endophthalmitis']}, 'descriptionModule': {'briefSummary': 'Specific study objectives include:\n\n* To describe patient and provider characteristics for aflibercept patients and aflibercept user injections by aflibercept dispensing device, overall, and stratified by time (quarterly, annually).\n* To estimate the annual and quarterly incidence of intraocular inflammation (IOI) and suspected endophthalmitis for aflibercept user injections by aflibercept dispensing device.\n\nSecondary objectives\n\n• To estimate the annual incidence of IOI and suspected endophthalmitis for aflibercept user injections by dispensing device, stratified by indication for use, history of IOI, and provider characteristics.', 'detailedDescription': 'This study is entirely descriptive using secondary data from the Vestrum Health Retina Treatment and Outcomes database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study period will span from 01 Jan 2014 (earliest complete data available) to 28 May 2022 (or most current data available). The study will include patients ≥18 years of age in Vestrum who have received one or more injections of aflibercept, regardless of indication, between 01 Jan 2014 to 30 Apr 2022 (one month look forward required). Patients must have at least one eligible treatment episode (defined as aflibercept injection followed by 28-day exposed period after injection) to be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for a Treatment Episode:\n\n1. Must have received one or more injections of aflibercept, regardless of indication, between 01Jan2014 to 30Apr2022\n2. Patients must have at least one eligible treatment episode a. Specification of laterality of aflibercept injection (left or right eye or both) for treatment episode\n\nExclusion Criteria for a Treatment Episode:\n\n1. A post-operative follow-up visit for any ocular surgery (excluding vitrectomy), within +/-28 days of aflibercept injection, as defined in the protocol\n2. Active steroid treatment, defined as steroid treatment (topical or intravitreal) on the date of aflibercept injection. This criterion is limited to date of aflibercept injection since steroids may be used to treat IOIs.\n3. Any treatment episode where a patient eye receives \\>1 (or an unknown) anti-VEGF injection on the index date (date of aflibercept injection).'}, 'identificationModule': {'nctId': 'NCT05791695', 'briefTitle': 'A Study of the Incidence of Intraocular Inflammation and Suspected Endophthalmitis Among Patients Treated With Aflibercept, Vial and Pre-filled Syringe, 2014-2022', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A US Real-World Evidence Study of the Incidence of Intraocular Inflammation and Suspected Endophthalmitis Among Patients Treated With Aflibercept, Vial and Pre-filled Syringe, 2014-2022', 'orgStudyIdInfo': {'id': 'VGFTe-OD-2222'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Patients', 'description': 'Patients ≥ 18 years who have received one or more injections of aflibercept during the study period', 'interventionNames': ['Other: Non Applicable']}], 'interventions': [{'name': 'Non Applicable', 'type': 'OTHER', 'description': 'No study-specific interventions for this observational study.', 'armGroupLabels': ['Study Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10591', 'city': 'Tarrytown', 'state': 'New York', 'country': 'United States', 'facility': 'Regeneron Research Site', 'geoPoint': {'lat': 41.07621, 'lon': -73.85875}}], 'overallOfficials': [{'name': 'Clinical Trial Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}