Analysis of Imaging Features From Patients Treated With Brolucizumab in the Post-marketing Setting With Reports of Retinal Vasculitis and/or Retinal Vascular Occlusion

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Whenever 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. All 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).

Official Title
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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

Conditions
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Intraocular Inflammation, Retinal Vascular Occlusion

Intervention / Treatment
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* Other: Brolucizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Brolucizumab<br>brolucizumab in routine clinical practice | Other: Brolucizumab<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye case classification based on imaging data | Eye case classification based on imaging data is provided: IOI: intraocular inflammation (posterior segment only) RV: Retinal vasculitis RO: Retinal vascular occlusion Not assessable: image quality concerns prevented grading None: no imaging features of IOI, RV, or RO | throughout the study period of 5 months | 
| Number of eye cases by anatomical location and sub-location | Number of eye cases by anatomical location and sub-location is provided: Retina: Vascular and general) Vitreous Choroid Optic nerve | throughout the study period of 5 months | 
| Number of eye cases by occlusion type by reading center eye case classification | Occlusion type by reading center eye case classification is provided: Central Branch Peripheral | throughout the study period of 5 months | 
| Number of eye cases by Anatomical location in relation to macula | Number of eye cases by Anatomical location in relation to macula is provided: | throughout the study period of 5 months | 
| Number of eye cases by extent of involvement of the retinal arterial and vein occlusion | Number of eye cases by Extent of involvement of the retinal arterial and vein occlusion is provided | throughout the study period of 5 months | 
| Number of eye cases by grading variables per imaging modality by reading center eye case classification | Number of eye cases by grading variables per imaging modality by reading center eye case classification is provided | throughout the study period of 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brolucizumab, Neovascular age-related macular degeneration, occlusive retinal vasculitis, retinal vasculitis, RV, retinal vascular occlusion, RO, ocular images