An Open-Label, Single-Arm, Multicenter, Phase IIIb Study in Patients With Neovascular Age-Related Macular Degeneration to Evaluate the Safety of Brolucizumab 6 mg in Prefilled Syringe
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- The Safety of Brolucizumab 6 mg Delivered in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration
研究概览
简要总结
This was a multicenter, open label study that is designed to evaluate the safety of brolucizumab 6 mg in a prefilled syringe in subjects with neovascular age related macular degeneration and to support collection of observations of the prefilled syringe use for intravitreal injection.
详细描述
The primary objective of this study was to evaluate the safety of brolucizumab 6 mg delivered in a pre-filled syringe (PFS) in subjects with neovascular age-related macular degeneration (nAMD) with the primary endpoint being the incidence of ocular and non-ocular adverse events (AEs). There were no other objectives for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
open label study
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained before any assessment is performed.
- •Study eye is diagnosed with neovascular age related macular degeneration and would need an intravitreal injection.
- •Subjects >= 50 years of age.
排除标准
- •Active infection or inflammation in the eyes.
- •Uncontrolled glaucoma.
- •History of a medical, ocular or non-ocular conditions, resulting in that the study medication cannot be safely administered.
- •Treatment with anti-VEGF intravitreal injection in the study eye within one month prior to enrollment.
- •The use of intraocular corticosteroids in the study eye within the last three months prior to enrollment.
- •Recent intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation.
- •Uncontrolled hypertension.
- •Other protocol defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
RTH258
brolucizumab 6 mg in a prefilled syringe
干预措施: RTH258 (Drug)
结局指标
主要结局
The Safety of Brolucizumab 6 mg Delivered in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration
时间窗: Up to Day 31
The safety is defined as the incidence of ocular and non-ocular adverse events
次要结局
未报告次要终点