NCT00950638已完成1 期
A Phase I Study to Establish the Safety and Tolerability of ARC1905 (Anti-C5 Aptamer) in Subjects With Dry Age-related Macular Degeneration
Ophthotech Corporation1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2009年7月16日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Presence of any dose-limiting toxicity (DLT), safety endpoints include adverse events, vital signs, ophthalmic variables and outcomes
研究概览
简要总结
The objectives of this study are to evaluate the safety and tolerability of ARC1905 intravitreous injection in subjects with geographic atrophy secondary to dry age-related macular degeneration (AMD).
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dry AMD (drusen and/or geographic atrophy) in both eyes
排除标准
- •Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication.
- •Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past twelve (12) weeks.
- •History of any of the following procedures: Posterior vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant or retinal detachment.
- •Any of the following underlying diseases including:
- •Diabetic retinopathy
- •History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV ), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within last 6 months, ventricular tachyarrythmias requiring ongoing treatment.
- •History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.
- •Clinically significant impaired renal (serum creatinine >2.5 mg/dl or status post renal transplant or receiving dialysis) or hepatic function. Subjects with results outside these ranges may be enrolled in consultation with Ophthotech.
- •Stroke (within 12 months of trial entry).
- •Any major surgical procedure within one month of trial entry. Previous therapeutic radiation in the region of the study eye. Any treatment with an investigational agent in the past 60 days for any condition.
- •Women who are pregnant or nursing. Known serious allergies to the fluorescein dye used in angiography or to the components of the ARC1905 formulation.
研究组 & 干预措施
dose comparison
Active Comparator
干预措施: Avacincaptad Pegol (Drug)
Dose comparison
Active Comparator
干预措施: Avacincaptad Pegol (Drug)
结局指标
主要结局
Presence of any dose-limiting toxicity (DLT), safety endpoints include adverse events, vital signs, ophthalmic variables and outcomes
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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