NCT00782093已完成1 期
A Phase 1 Ascending and Parallel Group Trial to Establish the Safety, Tolerability and Pharmacokinetics Profile of Volociximab (Alpha 5 Beta 1 Integrin Antagonist) in Subjects With Neovascular Age- Related Macular Degeneration
Ophthotech Corporation0 个研究点目标入组 63 人开始时间: 2008年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 主要终点
- The primary safety endpoint is the presence of any dose limiting toxicity (DLT)
研究概览
简要总结
The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of volociximab intravitreous injection in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Subfoveal choroidal neovascularization (CNV) due to AMD (i.e., predominantly classic, minimally classic or occult no classic) as documented by fluorescein angiogram.
排除标准
- •Any prior treatment for AMD or any intravitreal treatment for any indication in the study eye prior to the screening visit, except oral supplements of vitamins and minerals.
- •Previous or concomitant therapy with intravitreous corticosteroids.
- •Any of the following underlying diseases including:
- •Diabetic retinopathy
- •History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 19.6), 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 s/p renal transplant or receiving dialysis) or hepatic function. Patients 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, to the components of the ranibizumab formulation, or to the components of the volociximab formulation.
结局指标
主要结局
The primary safety endpoint is the presence of any dose limiting toxicity (DLT)
时间窗: 2 years
次要结局
未报告次要终点
研究者
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