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

Completed

• Conditions: Neovascular Age-related Macular Degeneration

• Registration Number: NCT06021366
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-07
• Primary Completion: 2022-08-29
• Study Completion: 2022-08-29
• Status Verified: 2023-08
• Study First Submitted: 2023-08-28
• Study First Submitted QC: 2023-08-28
• Last Update Submitted: 2023-08-28
• Study First Posted: 2023-09-01
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2089

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of brolucizumab injections	Up to 12 months

Secondary Outcome Measures

Name	Time	Method
Time difference between the last anti-VEGF treatment interval before switch to brolucizumab and the last brolucizumab treatment interval at 12 months	Up to 12 months

Trial Locations

Locations (1)

Novartis; 🇵🇹 Porto Salvo, Portugal