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临床试验/NCT06902207
NCT06902207已完成不适用

Real-life Incidence of Intraocular Inflammation Following Intravitreal Faricimab Therapy

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 6,053 人开始时间: 2024年11月10日最近更新:
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
6,053
试验地点
1
主要终点
Incidence of intraocular inflammation (IOI)

研究概览

简要总结

Faricimab (Vabysmo®), a novel pharmaceutical agent is a promising treatment for age-related macular degeneration and diabetic macular edema due to its dual mechanism of action, targeting both the VEGF and angiopoietin-2 (Ang-2) pathways, offering potential benefits in improving visual outcomes and reducing treatment burdens. The phase 3 TENAYA and LUCERNE clinical trials have demonstrated its efficacy and safety profile, leading to regulatory approval and increasing use in clinical practice. However, as with any new therapeutic agent, there is a critical need to monitor and evaluate real-world safety data to complement and validate clinical trial findings.

Intraocular inflammation (IOI), which is a significant adverse effect of intravitreal anti-VEGF injections, is of particular interest as it can vary from a mild transient reaction to a potentially vision-threatening outcome.

The incidence and severity of IOI in a real-world settings can vary from clinical trial results due to differences in patient populations, injection techniques, and clinical settings.

The aim of this study is to estimate the real-life incidence of intraocular inflammation following intravitreal faricimab injections at a large, regional highly specialized tertiary center.

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Incidence of intraocular inflammation (IOI)

时间窗: 01/NOV/2023 - 31/AUG/2024

Incidence of IOI following the faricimab injection procedure, described as cases per eye, cases per patient and cases per injection

次要结局

  • Differences in age(01/NOV/2023 - 31/AUG/2024)
  • Differences in sex(01/NOV/2023 - 31/AUG/2024)
  • Differences in number of anti-VEGF injections(01/NOV/2023 - 31/AUG/2024)
  • Differences between treatment-naïve and switch-patients(01/NOV/2023 - 31/AUG/2024)
  • Time from injection to onset of IOI(01/NOV/2023 - 31/AUG/2024)
  • Disease duration of IOI(01/NOV/2023 - 31/AUG/2024)
  • Functional outcome of IOI cases(01/NOV/2023 - 31/AUG/2024)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Miklos Schneider MD, PhD

Principal Investigator

Rigshospitalet, Denmark

研究点 (1)

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