A 52-weeks Observational Study to Evaluate the Safety of Brolucizumab (6mg) in Patients With Neovascular Age-related Macular Degeneration (nAMD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 329
- 试验地点
- 1
- 主要终点
- Number of patients with adverse events in the eyes on therapy
研究概览
简要总结
This study was a prospective, uncontrolled, central registration system, multicenter, domestic observational study (special drug-use surveillance) to evaluate the safety of 52-week clinical treatment with Beovu kit for intravitreal injection in nAMD patients.
详细描述
The observational period was 1 year (52 weeks) from the first brolucizumab administration in the primary treated eye.
However, if brolucizumab was discontinued in the primary treated eye and if the treatment was discontinued less than 52 weeks observation period, the observation period was to be up to 90 days after the last dose of this drug. This was set in order to collect data as much as possible based on the clinical effect of the drug. If 30 days after the last dose of this drug in a discontinued patient exceeds 52 weeks of the observation period, the patient was to be monitored for adverse events until 30 days after the last dose of this drug.
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
- — 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must provide written consent to cooperate in this study before treatment with Beovu kit for intravitreal injection
- •Patients using Beovu kit for intravitreal injection for the first time for the following indication:
- •Indication: age-related macular degeneration with subfoveal choroidal neovascularization
排除标准
- •Patients with a history of treatment with a drug containing the same ingredient (brolucizumab; investigational drug or post-marketing clinical study drug) as Beovu kit for intravitreal injection
研究组 & 干预措施
Beovu
Brolucizumab (Genetical Recombination) 6 mg (0.05 mL) was administered by intravitreal injection every 4 weeks for the first three doses(loading phase). In the following maintenance phase, Brolucizumab was basically administered every 12 weeks. The interval between treatments was adjusted as appropriate according to the symptoms. The interval between two doses was not to be shorter than 8 weeks
干预措施: Beovu (Drug)
结局指标
主要结局
Number of patients with adverse events in the eyes on therapy
时间窗: 52 weeks
Number of patients with adverse events (AEs) in the eyes on therapy were reported
Number of patients with adverse events in other parts of the body (non-ocular)
时间窗: 52 weeks
Number of patients with adverse events (AEs) in other parts of the body (non-ocular) were reported
次要结局
- Number of patients with SAEs and ADRs in other parts of the body (non-ocular)(52 weeks)
- Number of patients with serious adverse events (SAEs) and adverse reactions (ADRs) in the eyes on therapy(52 weeks)
- Number of patients with adverse events, SAEs, ADRs and serious ADRs corresponding to the safety specifications(52 weeks)
- Incidence of adverse events by risk factor of the safety specifications (primary treated eyes only)(52 weeks)
- Proportion of patients with visual acuity (VA) worsening(52 weeks)
- Data on Beovu administration in the induction phase and maintenance phase(52 weeks)