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Treatment Patterns With Brolucizumab in Germany - a Retrospective Cohort Study Based on Longitudinal Prescription Data: REALIZE Study

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Novartis

Status

Completed

Conditions

Neovascular Age-related Macular Degeneration

Study type

Observational

Funder types

Industry

Identifiers

NCT06021366
CRTH258A2015

Details and patient eligibility

About

REALIZE was a single-arm retrospective cohort study which described treatment patterns with brolucizumab, including treatment intervals between anti-vascular endothelial growth factor (VEGF) injections before and after a switch to brolucizumab.

This study was conducted using German patient-level prescription data and the prescription date was used as a proxy for anti-VEGF injection date.

The study period was defined from the date of the first available anti-VEGF injection in the dataset to 30 November 2021. The index date for each patient was the date of the first brolucizumab injection, which could be anytime between 01 March 2020 (since brolucizumab became available in Germany for use outside of clinical trials in March 2020) and 30 November 2021. The date of the patient's first neovascular age-related macular degeneration (nAMD) diagnosis was assumed to be the date of the first anti-VEGF prescription in the database for that patient, from January 2015 onwards.

Enrollment

2,089 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

• Patients aged ≥50 years with a nAMD diagnosis, who received ≥1 brolucizumab prescription regardless of prior anti-VEGF treatment, and had a minimum of 12-month follow-up from index date.

Exclusion criteria

  • Patients without a record of prescription of any drug in the six months before the index date (pre-index period).
  • Patients with evidence of bilateral treatment with brolucizumab.

Trial design

2,089 participants in 8 patient groups

12-month follow-up cohort
Treatment-naïve 12-month sub-cohort
Treatment-experienced 12-month sub-cohort
Treatment-experienced, persistent 12-month sub-cohort
18-month follow-up cohort
Treatment-naïve 18-month sub-cohort
Treatment-experienced 18-month sub-cohort
Treatment-experienced, persistent 18-month sub-cohort

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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