Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection (DME, CRTH258B1401)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Proportion of patients with adverse events corresponding to each of the safety specifications during the observation period
研究概览
简要总结
This was a primary data collection-based observational special drug-use surveillance to be conducted in accordance with the Good Post-marketing Study Practice (GPSP) ordinance.
详细描述
This study aimed to evaluate the safety of Beovu kit for intravitreal injection in clinical use in diabetic macular edema (DME) patients.
The observation period was 1 year (52 weeks) from the first Beovu administration in the primary treated eye.
In patients discontinuing treatment with Beovu in the primary treated eye before Week 52, the following observation periods applied.
- Date of last Beovu dose + 90 days* in primary treated eye > Week 52: up to Week 52
- Date of last Beovu dose + 90 days* in primary treated eye ≤ Week 52: up to last dosing date in the primary treated eye + 90 days *90 days: to collect as much data as possible considering clinical effects
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
- 0 Years 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 the start of treatment with Beovu
- •Patients using Beovu for the first time for the following indication • Indication: diabetic macular edema
排除标准
- •Patients with a history of treatment with a drug containing the same ingredient (brolucizumab) as Beovu
结局指标
主要结局
Proportion of patients with adverse events corresponding to each of the safety specifications during the observation period
时间窗: Up to 52 weeks
Proportion of patients with adverse events corresponding to each of the safety specifications during the observation period was collected. Safety specifications: intraocular inflammation, endophthalmitis, intraocular pressure elevation, retinal detachment and retinal tear, retinal arterial embolic events, non-ocular arterial thromboembolic events, retinal vasculitis and retinal vascular occlusion
Proportions of patients with adverse events in the eyes on therapy during the observation period
时间窗: Up to 52 weeks
Proportions of patients with adverse events in the eyes on therapy during the observation period was collected
Proportion of patients with systemic adverse events during the observation period
时间窗: Up to 52 weeks
Proportion of patients with systemic (non-ocular) adverse events during the observation period was collected
次要结局
- Proportion of patients with serious adverse events (SAEs) and adverse reactions in the eyes on therapy during the observation period(Up to 52 weeks)
- Proportion of patients with systemic SAEs and adverse reactions during the observation period(Up to 52 weeks)
- Proportion of patients with SAEs, adverse reactions and serious adverse reactions corresponding to the safety specifications during the observation period(Up to 52 weeks)
- Incidences of adverse events by risk factor of the safety specifications(Up to 52 weeks)
- Proportion of patients with VA worsening during the observation period(Up to 52 weeks)
- Proportion of patients by administration status in the induction and maintenance phase during the observation period(Up to 52 weeks)
- Proportion of patients by treated eye in the induction and maintenance phase during the observation period(Up to 52 weeks)