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

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Descriptive study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  BROLUCIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (S01LA06) brolucizumab

  brolucizumab
• Medical condition to be studied:
  Eye inflammation

  Retinal vasculitis

  Retinal vascular occlusion

Population studied

• Short description of the study population:
  The study considered the post-marketing cases of intraocular inflammation, retinal vasculitis, and retinal vascular/vein occlusion reported to Novartis Patient Safety worldwide, involving brolucizumab use as per routine clinical practice. Images requested and provided to Novartis until 31-Jan-2021, from all countries where brolucizumab was approved. Intraocular inflammation cases also included in the analysis.
• Age groups:
  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with intraocular inflammation, retinal vasculitis, and retinal vascular/vein occlusion
• Estimated number of subjects:
  198

Study design details

• Main study objective:
  This study provides real-world overview of the images collected at time of event of adverse events (AEs) of interest. The primary objective is to characterize the AEs of interest in terms of independent case classification based on imaging data. 1. Breakdown of imaging classification of the cases 2. Breakdown on location and findings by imaging modality
• Outcomes:
  Primary endpoints: 1. Case classification based on imaging data (RV vs. RO vs. RV/RO vs. IOI) 2. Location and findings description by imaging modality
• Data analysis plan:
  Number (%) assessable vs. non assessable cases based on imaging data were summarized among all cases with imaging data sent to the central reviewer. Data on patient characteristics (e.g. age, sex, race, county of origin), treatment, event outcome and visual loss/outcome distribution was retrieved from the ARGUS Safety database. Analyses related to the primary objective • An overall independent eye case classification based on all provided imaging data (“RV only” vs. “RO only” vs. “RV + RO only” vs. “IOI only (involving the posterior segment)” vs. “Not assessable” vs. “None”) acquired at the time the event was provided. • For each imaging finding (by location and finding), number (%) of cases with finding present by event type (RV/RO) as per independent review

Documents

Study results

CRTH258A2404 --legacy-clinical-study-report_2_Redacted