Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-31 @ 1:04 PM
Study NCT ID:
NCT06769412
Status:
COMPLETED
Last Update Posted:
2025-10-29
First Post:
2024-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Real-World Evidence Study for the Incidence of Retinal Vasculitis (RV) Among Adult Patients Receiving Aflibercept 2 mg in the United States (US)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D031300', 'term': 'Retinal Vasculitis'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533178', 'term': 'aflibercept'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 550000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-27', 'studyFirstSubmitDate': '2024-12-24', 'studyFirstSubmitQcDate': '2025-01-09', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of RV events', 'timeFrame': 'During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years'}, {'measure': 'Incidence of occlusive RV events confirmed through clinical chart abstraction', 'timeFrame': 'During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years'}, {'measure': 'Incidence of non-occlusive RV events confirmed through clinical chart abstraction', 'timeFrame': 'During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years'}, {'measure': 'Incidence of unconfirmed RV events', 'timeFrame': 'During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anti-vascular endothelial growth factor', 'Aflibercept', 'Neovascular age-related macular degeneration (nAMD)', 'Diabetic macular edema (DME)', 'Diabetic retinopathy (DR) without macular edema (ME)', 'Diabetic retinopathy (DR) with macular edema (ME)'], 'conditions': ['Retinal Vasculitis']}, 'descriptionModule': {'briefSummary': 'This study will describe and estimate the incidence of RV events among patients and patient eyes receiving aflibercept intravitreal (IVT) (Eylea® 2mg) therapy in US clinical practice. This study will also use clinical record review to confirm cases of RV first identified using International Classification of Diseases, tenth revision, Clinical Modification (ICD-10-CM) codes and to identify RV with occlusion.', 'detailedDescription': "This study is purely descriptive using secondary data from the Verana Health Retinal Outcomes module sourced from the American Academy of Ophthalmology's Intelligent Research in Sight (IRIS®) Registry"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will represent patients and patient-eyes who initiate aflibercept 2 mg injections to treat neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), diabetic retinopathy (DR) without DME, DR with macular edema (ME) status unknown, or ME following retinal vein occlusion (RVO).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Patient-eyes with at least one aflibercept 2 mg injection between January 1, 2017 and June 30, 2023\n2. Patient-eyes with at least one aflibercept 2 mg injection with a specified laterality. The earliest date of aflibercept injection will be the index date for each patient-eye\n3. Patient-eyes with diagnosis (documented through ICD-10-CM diagnosis code) of nAMD, DME, DR without DME, DR with ME status unknown, and/or ME following RVO in the same eye as the aflibercept injection within 14 days prior to the index date (inclusive)\n\nKey Exclusion Criteria:\n\n1. Patients with aflibercept 2 mg injection within 12 months (365 days) prior to the index date (not inclusive) will be excluded, as defined in the protocol\n2. Patient-eyes with a diagnosis of RV in the same eye as the aflibercept injection or with unspecified laterality within 12 months (365 days) prior to index date (inclusive), as defined in the protocol\n3. Aflibercept treatment episodes (aflibercept injections) with unspecified laterality, ophthalmic procedures or surgeries within 60 days prior to the injection date\n\nNOTE: Other protocol defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT06769412', 'briefTitle': 'A Real-World Evidence Study for the Incidence of Retinal Vasculitis (RV) Among Adult Patients Receiving Aflibercept 2 mg in the United States (US)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'Incidence of Retinal Vasculitis Among Patients Receiving Aflibercept 2 mg: A US Real-World Evidence Study Using the IRIS Registry', 'orgStudyIdInfo': {'id': 'VGFTe-OD-2457'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aflibercept IVT Cohort', 'description': 'Patients ≥ 18 years who initiated aflibercept 2 mg IVT during the study period', 'interventionNames': ['Drug: aflibercept 2 mg']}], 'interventions': [{'name': 'aflibercept 2 mg', 'type': 'DRUG', 'otherNames': ['Eylea®'], 'description': 'No study-specific investigations for this descriptive observational study', 'armGroupLabels': ['Aflibercept IVT Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10591', 'city': 'Tarrytown', 'state': 'New York', 'country': 'United States', 'facility': 'Regeneron Research Site', 'geoPoint': {'lat': 41.07621, 'lon': -73.85875}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}