NCT02396316
已完成
3 期
A Randomized, Double-masked, and Controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravitreal Administration of Aflibercept in Japanese Patients With Neovascular Glaucoma
概览
- 阶段
- 3 期
- 干预措施
- Aflibercept (Eylea, BAY 86-5321)
- 疾病 / 适应症
- Glaucoma, Neovascular
- 发起方
- Bayer
- 入组人数
- 54
- 主要终点
- Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1
- 状态
- 已完成
- 最后更新
- 8年前
概览
简要总结
To assess the efficacy and safety of the administration of aflibercept by intravitreal injection in comparison to sham to control intraocular pressure in patients with neovascular glaucoma.
研究者
入排标准
入选标准
- •Japanese men and women aged 20 years or older,
- •Patients diagnosed as having Neovascular glaucoma (NVG) with neovascularization in the anterior segment (both iris and anterior chamber angle),
- •Patients with Intraocular pressure (IOP) 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 Neovascular glaucoma
- •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
Aflibercept
Aflibercept 2 mg Intravitreal (IVT) injection group
干预措施: Aflibercept (Eylea, BAY 86-5321)
Sham Injection
Sham injection group
干预措施: Sham Injection
结局指标
主要结局
Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1
时间窗: From baseline to pre-dose at Week 1
It compared the change in IOP from baseline to pre-dose at Week 1 between the aflibercept group vs the sham group.
次要结局
- Percentage of Subjects Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Pre-dose at Week 1(From baseline to pre-dose at Week 1)
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