Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 70
- 主要终点
- Percentage of Patients With a Visual Field Improvement in the Study Eye
研究概览
简要总结
A multicenter, randomized, patient-masked, sham-controlled evaluation of the safety and effects on visual function of brimonidine intravitreal implant in patients with glaucomatous optic neuropathy. Patients will be followed for up to 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary open-angle glaucoma in one eye
- •Visual acuity 20/80 or better
- •Intraocular pressure in the study eye ≤ 24 mm Hg
- •Glaucomatous visual field loss - 7 dB to - 25 dB
排除标准
- •Known allergy to brimonidine tartrate
- •Uncontrolled systemic disease or infection of the eye
- •Recent eye surgery or injections in the eye
- •Female patients who are pregnant, nursing or planning a pregnancy
研究组 & 干预措施
400 ug Brimonidine Implant
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
干预措施: 400 ug Brimonidine Implant (Drug)
200 ug Brimonidine Implant
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
干预措施: 200 ug Brimonidine Implant (Drug)
Sham (no implant)
Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
干预措施: Sham (no implant) (Drug)
结局指标
主要结局
Percentage of Patients With a Visual Field Improvement in the Study Eye
时间窗: Baseline, Month 6
Visual field improvement in the study eye is determined using the Humphrey Field Analyzer (HFA 24-2) full threshold test and clinical expertise. The Humphrey Field Analyzer is a machine that helps to map the field (peripheral) of vision. An improvement is an increase in the field of vision. The percentage of patients with a visual field improvement in the study eye is reported.
次要结局
- Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye(Baseline, Month 6)