A Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 138
- 主要终点
- Percentage of Patients With Improvement in Best Corrected Visual Acuity (BCVA) of 15 or More Letters at Month 3
研究概览
简要总结
This is a 24-month study to evaluate multiple doses of AGN211745 (previously known as Sirna-027) in treatment of subfoveal choroidal neovascularization associated with age-related macular degeneration
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 years or older with "wet" AMD as determined by an ophthalmologist
- •decrease in visual acuity (20/40 to 20/640) in at least one eye
排除标准
- •Uncontrolled systemic disease
- •History of heart attack or stroke within one year of study entry
- •Symptomatic coronary artery disease
- •Cataracts that interfere with vision
研究组 & 干预措施
AGN 211745 Solution 1000 ug
AGN 211745 Solution 1000 ug
干预措施: AGN 211745 (Drug)
AGN 211745 Solution 300 ug
AGN 211745 Solution 300 ug
干预措施: AGN 211745 (Drug)
AGN 211745 Solution 100 ug
AGN 211745 Solution 100 ug
干预措施: AGN 211745 (Drug)
Ranibizumab 500 ug
Ranibizumab 500 ug
干预措施: Ranibizumab 500µg (Drug)
结局指标
主要结局
Percentage of Patients With Improvement in Best Corrected Visual Acuity (BCVA) of 15 or More Letters at Month 3
时间窗: Month 3
Percentage of patients with improvement in BCVA of 15 or more letters at Month 3. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
次要结局
- Foveal Thickness as Assessed by Optical Coherence Tomography (OCT) at Month 3(Month 3)
- Visual Functioning Questionnaire (VFQ) at Month 3(Month 3)
- Lesion Size as Assessed by Fluorescein Angiography (FA) and Photography at Month 3(Month 3)
- Time to Treatment With Standard of Care at Month 6(Month 6)