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

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

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.

Study Overview

• Status: Completed
• Conditions: Intraocular Inflammation; Retinal Vascular Occlusion
• Intervention / Treatment: Other: Brolucizumab

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).

• Study Type: Observational
• Enrollment (Actual): 198

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland
    • Novartis Investigative Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 103 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Brolucizumab; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Actual): January 4, 2022
• Study Completion (Actual): January 4, 2022

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Estimate): December 20, 2022

Study Record Updates

• Last Update Posted (Estimate): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Neovascular age-related macular degeneration; Brolucizumab; occlusive retinal vasculitis; retinal vasculitis; RV; retinal vascular occlusion; RO; ocular images
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Diseases; Uveal Diseases; Inflammation; Vasculitis; Uveitis; Retinal Vasculitis
• Other Study ID Numbers: CRTH258A2404

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No