Intraocular Inflammation, Retinal Vascular Occlusion
Conditions
Keywords
Brolucizumab, Neovascular age-related macular degeneration, occlusive retinal vasculitis, retinal vasculitis, RV, retinal vascular occlusion, RO, ocular images
Brief summary
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
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).
Interventions
OTHERBrolucizumab
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
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 105 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eye case classification based on imaging data | throughout the study period of 5 months | 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 |
| Number of eye cases by anatomical location and sub-location | throughout the study period of 5 months | Number of eye cases by anatomical location and sub-location is provided: * Retina: Vascular and general) * Vitreous * Choroid * Optic nerve |
| Number of eye cases by occlusion type by reading center eye case classification | throughout the study period of 5 months | Occlusion type by reading center eye case classification is provided: * Central * Branch * Peripheral |
| Number of eye cases by Anatomical location in relation to macula | throughout the study period of 5 months | Number of eye cases by Anatomical location in relation to macula is provided: |
| Number of eye cases by extent of involvement of the retinal arterial and vein occlusion | throughout the study period of 5 months | Number of eye cases by Extent of involvement of the retinal arterial and vein occlusion is provided |
| Number of eye cases by grading variables per imaging modality by reading center eye case classification | throughout the study period of 5 months | Number of eye cases by grading variables per imaging modality by reading center eye case classification is provided |
Countries
Switzerland
Outcome results
None listed