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

NCT ID: NCT06021366

Last Updated: 2023-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2089 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-07

Study Completion Date

2022-08-29

Brief Summary

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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

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Conditions

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Neovascular Age-related Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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12-month follow-up cohort

No interventions assigned to this group

Treatment-naïve 12-month sub-cohort

No interventions assigned to this group

Treatment-experienced 12-month sub-cohort

No interventions assigned to this group

Treatment-experienced, persistent 12-month sub-cohort

No interventions assigned to this group

18-month follow-up cohort

No interventions assigned to this group

Treatment-naïve 18-month sub-cohort

No interventions assigned to this group

Treatment-experienced 18-month sub-cohort

No interventions assigned to this group

Treatment-experienced, persistent 18-month sub-cohort

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis

Porto Salvo, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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CRTH258A2015

Identifier Type: -

Identifier Source: org_study_id

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