A Single-arm, Non-randomized and Open-label Phase 3 Study Evaluating the Efficacy, Safety and Tolerability of Intravitreal Aflibercept in Japanese Patients With Neovascular Glaucoma (NVG)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 16
- 试验地点
- 7
- 主要终点
- Change in Intraocular Pressure (IOP) From Baseline to Week 1
研究概览
简要总结
The researchers in this trial want to learn how the drug aflibercept works in in Japanese patients with increased eye pressure that is caused by new blood vessels growing in the eye (neovascular glaucoma or NVG). They also want to find out how patient tolerate the application of the drug that is injected in the vitreous humor of the eye and if this will cause any medical problems during the trial (vitreous humor, also called vitreous body is the clear gel that fills the space between the lens and the retina of the eyeball).
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
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese men and women aged 20 years or older
- •Patients diagnosed as having NVG (neovascular glaucoma) with neovascularization in the anterior segment (both iris and anterior chamber angle)
- •Patients with IOP (intraocular pressure) higher than 25 mmHg in the study eye due to anterior segment (both iris and anterior chamber angle) neovascularization
排除标准
- •Patients with angle-closure due to conditions other than NVG or complete angle-closure due to NVG
- •Patients with a known or suspected ocular or peri-ocular infection
- •Patients with severe intraocular inflammation in the study eye
- •Women who are pregnant, suspected of being pregnant or lactating
- •Patients with known allergy to aflibercept
研究组 & 干预措施
NVG patients
Japanese patients with neovascular glaucoma
干预措施: Aflibercept (EYLEA, BAY86-5321) (Drug)
NVG patients
Japanese patients with neovascular glaucoma
干预措施: Topical IOP-lowering drugs (Drug)
结局指标
主要结局
Change in Intraocular Pressure (IOP) From Baseline to Week 1
时间窗: Baseline and week 1
The primary efficacy analysis was on the changes in IOP from baseline to Week 1 (LOCF).
次要结局
- Percentage of Participants Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Week 1(Baseline and week 1)