NCT06184360已完成不适用
Real-world Evaluation of BEOVU (Brolucizumab) Effectiveness and Durability for Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,079
- 试验地点
- 1
- 主要终点
- Change in Injection Interval at 12 Months of Brolucizumab Treatment Compared with Prior Anti-vascular Endothelial Growth Factor (VEGF) Treatment
研究概览
简要总结
This was a retrospective, observational cohort study. Data were analyzed from the Intelligent Research in Sight (IRIS) registry from October 8, 2019, through November 26, 2021, with a follow-up period of 12 months following the first brolucizumab injection (index date).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old at the time of their first (index) injection of brolucizumab.
- •Had documented neovascular age-related macular degeneration (nAMD) on or within 3 years before the index injection.
- •Used only brolucizumab for at least 12 months (± 45 days) after the index injection, with at least 1 brolucizumab injection given within the first 6 months after the index injection and at least 1 additional brolucizumab injection given at 6-12 months after the index injection.
排除标准
- •Had received any other anti-VEGF agent between the index injection and 12-month follow-up.
- •Lacked information about the laterality of disease at the time of the index injection.
- •Lacked visual acuity assessments on or within 30 days before the index injection or at 6, 9, and 12 months after the index injection (all of the latter ± 45 days).
结局指标
主要结局
Change in Injection Interval at 12 Months of Brolucizumab Treatment Compared with Prior Anti-vascular Endothelial Growth Factor (VEGF) Treatment
时间窗: Baseline up to 12 months
Number of brolucizumab injections prior to adverse event
时间窗: Baseline up to 12 months
Time to adverse event
时间窗: Baseline up to 12 months
Change in Best Recorded Visual Acuity, Stratified by Prior Treatment Status
时间窗: Baseline up to 12 months
Number of eyes with adverse events
时间窗: Baseline up to 12 months
次要结局
- Brolucizumab Injection Interval and Interval Extension, Stratified by Pre-Switch Interval(Baseline up to 12 months)
研究者
研究点 (1)
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