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

NCT06021366 | Completed

• 1 other identifier: CRTH258A2015
• Study Type: observational
• Target: 2,089
• Locations: 1 country
• Sites: 1

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.

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Number of brolucizumab injections

  Up to 12 months

Secondary Outcomes (1)

• 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

Study Arms (8)

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

Porto Salvo, 2740-255, Portugal

Location

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: August 28, 2023
• First Posted: September 1, 2023
• Study Start: January 7, 2022
• Primary Completion: August 29, 2022
• Study Completion: August 29, 2022
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

PT (1)