Clinical trial NCT05657158: Analysis of Imaging Features From Patients Treated With Brolucizumab in the Post-marketing Setting With Reports of Retinal Vasculitis and/or Retinal Vascular Occlusion
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Inflammation
Retinal Vascular Occlusion
Keywords: Brolucizumab
Neovascular age-related macular degeneration
occlusive retinal vasculitis
retinal vasculitis
RV
retinal vascular occlusion
RO
ocular images
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-12-20
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Eye case classification based on imaging data
timeFrame: throughout the study period of 5 months
measure: Number of eye cases by anatomical location and sub-location
timeFrame: throughout the study period of 5 months
measure: Number of eye cases by occlusion type by reading center eye case classification
timeFrame: throughout the study period of 5 months
measure: Number of eye cases by Anatomical location in relation to macula
timeFrame: throughout the study period of 5 months
measure: Number of eye cases by extent of involvement of the retinal arterial and vein occlusion
timeFrame: throughout the study period of 5 months
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
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis Investigative center
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: