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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT06021366
Collaborator
(none)
2,089
Enrollment
1
Location
7.7
Actual Duration (Months)
271.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2089 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Treatment Patterns With Brolucizumab in Germany - a Retrospective Cohort Study Based on Longitudinal Prescription Data: REALIZE Study
    Actual Study Start Date :
    Jan 7, 2022
    Actual Primary Completion Date :
    Aug 29, 2022
    Actual Study Completion Date :
    Aug 29, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Number of brolucizumab injections [Up to 12 months]

    Secondary Outcome Measures

    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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Porto Salvo Portugal 2740-255

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT06021366
    Other Study ID Numbers:
    • CRTH258A2015
    First Posted:
    Sep 1, 2023
    Last Update Posted:
    Sep 1, 2023
    Last Verified:
    Aug 1, 2023
    Additional relevant MeSH terms:
    Macular Degeneration

    Study Results

    No Results Posted as of Sep 1, 2023