Evaluation of Safety and Efficacy of Ranibizumab in Glaucoma Patients Treated With Filtration Tubes"
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Tube Success at 6 Months
研究概览
简要总结
To determine whether ranibizumab therapy before and after tube insertion for glaucoma surgeries can maintain the patency of the tube and prevent scar formation, and increase the chances for a successful procedure compared to observation.
详细描述
This is a randomized, open-label, Phase I/II study of intravitreally administered ranibizumab for the treatment of tube patency in glaucoma patients.
Thirty (30) patients with severe glaucoma requiring tubes will be randomized (2:1) to either ranibizumab or observation.
Consented, enrolled subjects assigned to the treatment group will receive open-label intravitreal injection of 0.5 mg ranibizumab 1 week prior to tube insertion and then monthly x 2 more injections Sham intravitreal injections for the observation group will NOT be performed.
Study periods:
Study start date: May 1st, 2007 (estimated) Enrollment period: 6-8 months (estimated) Follow-up period: 6 months Study end Date: December 1st, 2010 (estimated)
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ability to provide written informed consent and comply with study assessment for the full duration of the study.
- •diagnosis of glaucoma and determined to be candidate for therapy with tube insertion.
排除标准
- •pregnant or lactating females
- •Persons on oral contraceptives and women of child-bearing age
- •prior enrollment in the study
- •any conditions the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- •participation in another simultaneous medical investigation or trial
- •history of active inflammatory, infectious, or idiopathic keratitis precluding view of anterior segment structures
- •previous injections of ranibizumab in either eye.
- •Persons on Plavix (clopidogrel bisulfate) and coumadin
- •Persons with uncontrolled high blood pressure
- •Persons with renal or liver disease
研究组 & 干预措施
Ranibizumab
Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Tube Success at 6 Months
时间窗: 6 months
Criteria for success at 6 months postoperatively was intraocular pressure (IOP) \< 18mmHg without the necessity for adjunctive medication for pressure or IOP \< 15mmHg with \<=1 adjunctive medication.
次要结局
- Significant Ocular Adverse Events(6 months)