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

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06021366
• Other study ID #: CRTH258A2015
• Status: Completed
• Start date: January 7, 2022
• Est. completion date: August 29, 2022

Study information

• Verified date: August 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2089
• Est. completion date: August 29, 2022
• Est. primary completion date: August 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration

Locations

Country	Name	City	State
Portugal	Novartis	Porto Salvo

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of brolucizumab injections		Up to 12 months
Secondary	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