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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06021366
Enrollment
2089
Registered
2023-09-01
Start date
2022-01-07
Completion date
2022-08-29
Last updated
2023-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular Age-related Macular Degeneration

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.

Interventions

None listed

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Number of brolucizumab injectionsUp to 12 months

Secondary

MeasureTime frame
Time difference between the last anti-VEGF treatment interval before switch to brolucizumab and the last brolucizumab treatment interval at 12 monthsUp to 12 months

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026