Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
Study NCT ID:
NCT05657158
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2022-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of Imaging Features From Patients Treated With Brolucizumab in the Post-marketing Setting With Reports of Retinal Vasculitis and/or Retinal Vascular Occlusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D031300', 'term': 'Retinal Vasculitis'}], 'ancestors': [{'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000622091', 'term': 'brolucizumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-19', 'studyFirstSubmitDate': '2022-11-16', 'studyFirstSubmitQcDate': '2022-12-19', 'lastUpdatePostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eye case classification based on imaging data', 'timeFrame': 'throughout the study period of 5 months', 'description': 'Eye case classification based on imaging data is provided:\n\n* IOI: intraocular inflammation (posterior segment only)\n* RV: Retinal vasculitis\n* RO: Retinal vascular occlusion\n* Not assessable: image quality concerns prevented grading\n* None: no imaging features of IOI, RV, or RO'}, {'measure': 'Number of eye cases by anatomical location and sub-location', 'timeFrame': 'throughout the study period of 5 months', 'description': 'Number of eye cases by anatomical location and sub-location is provided:\n\n* Retina: Vascular and general)\n* Vitreous\n* Choroid\n* Optic nerve'}, {'measure': 'Number of eye cases by occlusion type by reading center eye case classification', 'timeFrame': 'throughout the study period of 5 months', 'description': 'Occlusion type by reading center eye case classification is provided:\n\n* Central\n* Branch\n* Peripheral'}, {'measure': 'Number of eye cases by Anatomical location in relation to macula', 'timeFrame': 'throughout the study period of 5 months', 'description': 'Number of eye cases by Anatomical location in relation to macula is provided:'}, {'measure': 'Number of eye cases by extent of involvement of the retinal arterial and vein occlusion', 'timeFrame': 'throughout the study period of 5 months', 'description': 'Number of eye cases by Extent of involvement of the retinal arterial and vein occlusion is provided'}, {'measure': 'Number of eye cases by grading variables per imaging modality by reading center eye case classification', 'timeFrame': 'throughout the study period of 5 months', 'description': 'Number of eye cases by grading variables per imaging modality by reading center eye case classification is provided'}]}, 'conditionsModule': {'keywords': ['Brolucizumab', 'Neovascular age-related macular degeneration', 'occlusive retinal vasculitis', 'retinal vasculitis', 'RV', 'retinal vascular occlusion', 'RO', 'ocular images'], 'conditions': ['Intraocular Inflammation', 'Retinal Vascular Occlusion']}, 'descriptionModule': {'briefSummary': 'This non-interventional descriptive study was undertaken to better understand the most common imaging features associated with inflammation arising in the post-marketing setting when brolucizumab was prescribed in routine clinical practice.', 'detailedDescription': 'The purpose of this retrospective study analysis was to better characterize the risk of inflammatory events arising from use of brolucizumab in routine clinical practice through analysis of independently reviewed ocular imaging data obtained from cases with reports of intraocular inflammation (IOI), retinal vasculitis (RV) and/or Retinal vascular occlusion (RO) and to provide a description of these features.\n\nWhenever an AE report pertaining to RV and/or RO was reported to Novartis Patient Safety, a follow-up check list (targeted follow-up checklists \\[TFUs\\]) was sent by Novartis to the reporter. The reporter was encouraged to share all available images obtained as part of clinical practice, irrespective of the timing or event (i.e. images before, during, and after event could be provided). The focus and main efforts of this data collection was on adverse events of RV and/or RO; for other IOI only events, the images were not actively requested in the case documentation process, however in some cases these were spontaneously reported by the reporter.\n\nAll images obtained from Feb 2020 up to 31 Jan 2021 were reviewed in a standardized manner by an external reading center. Dedicated grading lists were developed for each of the image modalities: Fluorescein Angiography (FA), Fundus Photography (FP), Indocyanine Green Angiography (ICGA), Optical Coherence Tomography (OCT), and OCT Angiography (OCT-A).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'As this study used secondary data from Novartis Patient Safety database, there was no specified set of subject population in this study and all cases with event of interest and available images were retrieved.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participants with cases of RV and/or RO reported to Novartis Patient Safety following brolucizumab use in routine clinical practice for which images were provided to Novartis and read by the Reading Centre'}, 'identificationModule': {'nctId': 'NCT05657158', 'briefTitle': 'Analysis of Imaging Features From Patients Treated With Brolucizumab in the Post-marketing Setting With Reports of Retinal Vasculitis and/or Retinal Vascular Occlusion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Retrospective Analysis of Imaging and Clinical Features From Patients Treated With Brolucizumab in Post-marketing Setting With Reports of Intraocular Inflammation and/or Retinal Vascular Occlusion', 'orgStudyIdInfo': {'id': 'CRTH258A2404'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Brolucizumab', 'description': 'brolucizumab in routine clinical practice', 'interventionNames': ['Other: Brolucizumab']}], 'interventions': [{'name': 'Brolucizumab', 'type': 'OTHER', 'description': 'Participants with cases of RV and/or RO reported to Novartis Patient Safety following brolucizumab use in routine clinical practice for which images were provided to Novartis and read by the Reading Centre were included', 'armGroupLabels': ['Brolucizumab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basel', 'country': 'Switzerland', 'facility': 'Novartis Investigative center', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}