NCT00569140已完成1 期
A Phase 1, Single Ascending Dose Trial to Establish the Safety, Tolerability and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) Monotherapy and of E10030 Given in Combination With Lucentis®0.5 Mg/Eye in Subjects With Neovascular Age-Related Macular Degeneration
Ophthotech Corporation1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2007年12月最近更新:
适应症
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
- 18
- 试验地点
- 1
- 主要终点
- Ophthalmic DLTs
研究概览
简要总结
The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of E10030 intravitreous injection when administered as monotherapy or in combination with Lucentis® 0.5 mg/eye 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
- Na
- 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 100 Years（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
排除标准
- •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 with 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.
- •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.
- •Known serious allergies to the fluorescein dye used in angiography, to the components of the ranibizumab formulation, or to the components of the E10030 formulation.
研究组 & 干预措施
1
No Intervention
E10030
干预措施: E10030 (Drug)
结局指标
主要结局
Ophthalmic DLTs
时间窗: immediate
次要结局
- adverse events(immendiate)
研究者
研究点 (1)
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