An observational study in Intraocular Inflammation and Retinal Vascular Occlusion, sponsored by Novartis Pharmaceuticals. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 105 Years. Per ClinicalTrials.gov, last updated 2022-12-20.
Sponsored by Novartis Pharmaceuticals · Observational
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.
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).
335 studies on the registry are indexed under Uveitis; 37 are open to participants now.
This study's enrollment of 198 is above the median of 100 across 107 observational studies indexed under Uveitis.
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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.
Inclusion Criteria:
brolucizumab in routine clinical practice
Other: Brolucizumab
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
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
Time frame: 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
Time frame: 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
Time frame: 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:
Time frame: 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
Time frame: 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
Time frame: throughout the study period of 5 months
Plan to share: No
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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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