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

Completed

• Conditions: Intraocular Inflammation; Retinal Vascular Occlusion
• Interventions: Other: Brolucizumab

• Registration Number: NCT05657158
• Lead Sponsor: Novartis Pharmaceuticals

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).

Study Timeline

• Study Start: 2021-08-23
• Primary Completion: 2022-01-04
• Study Completion: 2022-01-04
• Study First Submitted: 2022-11-16
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-19
• Last Update Submitted: 2022-12-19
• Study First Posted: 2022-12-20
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Brolucizumab	Brolucizumab	brolucizumab in routine clinical practice

Primary Outcome Measures

Name	Time	Method
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 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
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
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 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

Trial Locations

Locations (1)

Novartis Investigative center; 🇨🇭 Basel, Switzerland