NCT03446144撤回2 期
A Phase 2, Placebo-Controlled, Double-Masked Study to Assess Safety and Efficacy of ISIS 696844, an Antisense Inhibitor of Complement Factor B, in Patients With Geographic Atrophy Secondary (GA) to Age-Related Macular Degeneration (AMD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 13
- 主要终点
- Efficacy of IONIS-FB-Lrx
研究概览
简要总结
The purpose of this study is to assess the Safety and Efficacy of IONIS-FB-Lrx for up to 120 patients with Geographic Atrophy secondary to Age Related Macular Degeneration
详细描述
This study will assess changes in complement factor B over a 69-week treatment period in a patient population 55 and older with well-demarcated Geographic Atrophy secondary to 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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double Masked
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have given written informed consent and be able to comply with study requirements
- •Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal. Males must be surgically sterile or, if engaged in sexual relations with a female of child bearing potential, the subject must be using an acceptable contraceptive method from the time of signing the informed consent form until at least a period of 13 weeks after the last dose of Study Drug (ISIS 696844 or placebo)
- •Well-demarcated Geographic Atrophy due to Age Related Macular Degeneration
排除标准
- •Clinically-significant abnormalities in medical history
- •Diagnosis of primary or secondary immunodeficiencies of B lymphocyte function, splenectomy, glomerulonephritis or history of recurrent meningococcal disease
- •Diabetes mellitus or thyroid disease unless well controlled for a period of at least 3 months
- •Clinically-significant abnormalities in screening laboratory values
- •Unwillingness to be administered, or history of a serious reaction to protocol required vaccines
- •Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
- •History or presence of a disease other than AMD in study eye
研究组 & 干预措施
IONIS-FB-Lrx
Experimental
干预措施: IONIS-FB-Lrx (Drug)
Placebo (sterile saline 0.9%)
Placebo Comparator
干预措施: Placebo (sterline saline 0.9%) (Drug)
结局指标
主要结局
Efficacy of IONIS-FB-Lrx
时间窗: Up to 74 weeks
The Efficacy of IONIS-FB-Lrx will be measured by the percent change in plasma complement factor B level
次要结局
- Incidence and severity of adverse events that are related to treatment with IONIS-FB-Lrx(Up to 86 weeks)
- Proportion of patients in each treatment group achieving a >50% reduction of plasma complement factor B(Up to 74 weeks)
- Effect of IONIS-FB-Lrx on the rate of change of the area of GA secondary to AMD(Up to 74 weeks)
- Effect of factor B reduction on other components of the complement pathways in AMD patients(Up to 74 weeks)
研究者
研究点 (13)
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