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

NCT05657158 | Completed

• 1 other identifier: CRTH258A2404
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Brolucizumab

brolucizumab in routine clinical practice

Other: Brolucizumab

Interventions

Brolucizumab OTHER

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

Brolucizumab

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative center

Basel, Switzerland

Location

MeSH Terms

Conditions

Uveitis; Retinal Vasculitis

Interventions

brolucizumab

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Retinal Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 20, 2022
• Study Start: August 23, 2021
• Primary Completion: January 4, 2022
• Study Completion: January 4, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)