Treatment Patterns With Brolucizumab in Germany - a Retrospective Cohort Study Based on Longitudinal Prescription Data: REALIZE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,089
- 试验地点
- 1
- 主要终点
- Number of brolucizumab injections
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Number of brolucizumab injections
时间窗: Up to 12 months
次要结局
- 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)