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Completed

NCT Number: 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

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.

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Key information

Conditions

Intraocular Inflammation Cardiovascular Diseases Eye Diseases Retinal Diseases Retinal Vascular Occlusion Retinal Vasculitis Uveal Diseases Uveitis Vascular Diseases Vasculitis

Age range

18 year–105 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative center

Basel, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Eye case classification based on imaging data

    Time frame: 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

  2. Number of eye cases by anatomical location and sub-location

    Time frame: 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

  3. Number of eye cases by occlusion type by reading center eye case classification

    Time frame: throughout the study period of 5 months

    Occlusion type by reading center eye case classification is provided:

    • Central
    • Branch
    • Peripheral

  4. Number of eye cases by Anatomical location in relation to macula

    Time frame: throughout the study period of 5 months

    Number of eye cases by Anatomical location in relation to macula is provided:

  5. Number of eye cases by extent of involvement of the retinal arterial and vein occlusion

    Time frame: throughout the study period of 5 months

    Number of eye cases by Extent of involvement of the retinal arterial and vein occlusion is provided

  6. Number of eye cases by grading variables per imaging modality by reading center eye case classification

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 20, 2022
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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