A retrospective, 12-month, multicenter study to evaluate real-world brolucizumab effectiveness and safety in Japanese patients with neovascular age-related macular degeneration (nAMD) (Pheasant Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 主要终点
- Percentage(%) of patients that are absent of SRF and IRF at Month 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 50age old over 至 No limit（—）
- 性别
- All
入选标准
- •1.Diagnosis of nAMD
- •2.Patients with >= 50 years of age at index
- •3.Receipt of first injection of brolucizumab during the index period
- •4.Signed or Verbal informed consent
排除标准
- •Patients treated for RVO, DME, mCNV, and have diagnoses of diabetes-related macular degeneration within 6 months prior to the index date
- •Any active intraocular or periocular infection or active intraocular inflammation in the study eye at index date
- •3.Patients who have any contraindication and are not eligible for treatment with brolucizumab as according to the label
- •Patients who were treated with more than 3 types of anti-VEGF before index date (5th line brolucizumab patients or more)
- •Patients participating in parallel in an interventional clinical trial
- •Note: if a patient experiences an adverse event, they may still be recruited in another study following this adverse event if they fulfill their inclusion criteria. Their data will still be collected as planned by the current protocol
- •Patients participating in Post-Marketing surveillance with brolucizumab
结局指标
主要结局
Percentage(%) of patients that are absent of SRF and IRF at Month 12
时间窗: Month 12
Composite binary: absence of IRF and the absence of SRF. - **Population**: real-world nAMD patients - **Treatment**: brolucizumab as received in routine care - **Summary measure**: percentage of treated patients who reach the endpoint at 12 months - **Intercurrent events**: treatment discontinuation for any reason (including switching to another anti-VEGF) - **Strategy for intercurrent events**: while-on-treatment strategy Patients who have discontinued brolucizumab before Month 12 will be counted as not having achieved the endpoint of fluid resolution (absence of SRF and IRF), unless they reached it at the last visit while still on brolucizumab treatment before the discontinuation.
次要结局
未报告次要终点