Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-27 @ 11:39 PM
Study NCT ID:
NCT06184360
Status:
COMPLETED
Last Update Posted:
2023-12-28
First Post:
2023-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-world Evaluation of BEOVU (Brolucizumab) Effectiveness and Durability for Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD)
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2079}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-14', 'studyFirstSubmitDate': '2023-12-14', 'studyFirstSubmitQcDate': '2023-12-14', 'lastUpdatePostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Best Recorded Visual Acuity, Stratified by Prior Treatment Status', 'timeFrame': 'Baseline up to 12 months'}, {'measure': 'Change in Injection Interval at 12 Months of Brolucizumab Treatment Compared with Prior Anti-vascular Endothelial Growth Factor (VEGF) Treatment', 'timeFrame': 'Baseline up to 12 months'}, {'measure': 'Number of eyes with adverse events', 'timeFrame': 'Baseline up to 12 months'}, {'measure': 'Time to adverse event', 'timeFrame': 'Baseline up to 12 months'}, {'measure': 'Number of brolucizumab injections prior to adverse event', 'timeFrame': 'Baseline up to 12 months'}], 'secondaryOutcomes': [{'measure': 'Brolucizumab Injection Interval and Interval Extension, Stratified by Pre-Switch Interval', 'timeFrame': 'Baseline up to 12 months'}]}, 'conditionsModule': {'conditions': ['Neovascular (Wet) Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'This was a retrospective, observational cohort study. Data were analyzed from the Intelligent Research in Sight (IRIS) registry from October 8, 2019, through November 26, 2021, with a follow-up period of 12 months following the first brolucizumab injection (index date).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This was a retrospective, noninterventional cohort study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years old at the time of their first (index) injection of brolucizumab.\n* Had documented neovascular age-related macular degeneration (nAMD) on or within 3 years before the index injection.\n* Used only brolucizumab for at least 12 months (± 45 days) after the index injection, with at least 1 brolucizumab injection given within the first 6 months after the index injection and at least 1 additional brolucizumab injection given at 6-12 months after the index injection.\n\nExclusion Criteria:\n\n* Had received any other anti-VEGF agent between the index injection and 12-month follow-up.\n* Lacked information about the laterality of disease at the time of the index injection.\n* Lacked visual acuity assessments on or within 30 days before the index injection or at 6, 9, and 12 months after the index injection (all of the latter ± 45 days).'}, 'identificationModule': {'nctId': 'NCT06184360', 'briefTitle': 'Real-world Evaluation of BEOVU (Brolucizumab) Effectiveness and Durability for Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Real-world Evaluation of BEOVU (Brolucizumab) Effectiveness and Durability for Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD)', 'orgStudyIdInfo': {'id': 'CRTH258A2014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment-Experienced'}, {'label': 'Treatment-Naive'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}