NCT04985487招募中不适用
Regulatory Post-Marketing Surveillance (rPMS) Study for Brolucizumab(Beovu ® Injection, Beovu ®Prefilled Syringe)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Incidence of adverse events at 12 weeks
研究概览
简要总结
This study is an open-label, multicenter, single-arm, observational post-marketing surveillance.
详细描述
The investigators will collect safety information and evaluate effectiveness in patients who are prescribed Beovu ® Injection, Beovu ®Prefilled Syringe (brolucizumab) in the approved indication after receiving informed consent over a period of 12 weeks. In addition, longer-term data (24 weeks, optionally 36 weeks) will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥18 years with nAMD that are prescribed with Brolucizumab as per approved local product information
- •Patients who consent to participate in the study after the purpose and nature of the study have clearly explained to them (written informed consent)
排除标准
- •Contraindications as per local prescribing information 1) Hypersensitivity to the active substance or to any of the excipients. 2) Active or suspected ocular or periocular infection. 3) Active intraocular inflammation.
- •Patients participating in other investigational drug trial
结局指标
主要结局
Incidence of adverse events at 12 weeks
时间窗: 12 weeks
Incidence of adverse events and serious adverse events
次要结局
- Proportion of patients gaining or losing more than 15 letters on the ETDRS chart(Week 12, week 24, optionally week 36)
- Mean change of Central Subfield Thickness (CST) from baseline(Baseline, week 12, week 24, optionally week 36)
- Mean Central Subfield Thickness (CST)(Baseline, Week 12, week 24, optionally week 36)
- Predictive factors of treatment outcomes (persistent disease activity)(Week 24)
- Number of participants with post injection empirical treatment(Week 12, week 24, optionally week 36)
- Percentage of patients completing the loading phase(4 months)
- Mean Best Corrected Visual Acuity (BCVA)(Baseline, week 12, week 24, optionally week 36)
- Incidence of adverse events at 24 weeks and optionally at 36 weeks(Up to 36 weeks)
- Mean change of Best Corrected Visual Acuity (BCVA) from baseline(Baseline, week 12, week 24, optionally week 36)
- Number of injections(Up to 36 weeks)
- Percentage of patients who maintained with 12 weeks interval(Up to 36 weeks)
- Proportion of patients with retinal fluid(Week 12, week 24, optionally week 36)
- Prior anti-VEGF treatment history - number of prior injections(Baseline)
- Prior anti-VEGF treatment history - agent of prior injections(Baseline)
- Treatment naïve/non-naïve(Baseline)
- Treatment interval(Up to week 36)
- Concomitant treatments(Baseline)
研究者
研究点 (1)
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