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

Intraocular Inflammation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05657158
• Other study ID #: CRTH258A2404
• Status: Completed
• Start date: August 23, 2021
• Est. completion date: January 4, 2022

Study information

• Verified date: December 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: January 4, 2022
• Est. primary completion date: January 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Intraocular Inflammation
• Retinal Vascular Occlusion
• Retinal Vasculitis
• Uveitis
• Vasculitis

Intervention

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

Locations

Country	Name	City	State
Switzerland	Novartis Investigative center	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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