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

Bayer0 个研究点目标入组 54 人2015年4月2日

适应症Glaucoma, Neovascular

干预措施Aflibercept (Eylea, BAY 86-5321)Sham Injection

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

概览研究者入排标准研究组 & 干预措施结局指标相似试验

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.

注册库

clinicaltrials.gov

开始日期

2015年4月2日

结束日期

2016年9月6日

最后更新

8年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Bayer

责任方

Sponsor

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)