NCT00725686已完成1 期
A Phase I Open-Label, Dose Escalation Trial Of REDD14NP Delivered By A Single Intravitreal Injection To Patients With Choroidal Neovascularization (CNV) Secondary To Exudative Age-Related Macular Degeneration ("Wet AMD").
Quark Pharmaceuticals12 个研究点 分布在 2 个国家目标入组 54 人开始时间: 2007年2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
- 54
- 试验地点
- 12
- 主要终点
- To determine the safety and tolerability of PF-04523655 when administered as a single intravitreal injection
研究概览
简要总结
The aim of the study is to evaluate whether PF-04523655 is safe in the treatment of neovascular/wet AMD
详细描述
Dose escalation safety study
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥ 50 years old and in general good health. Patients with medically controlled chronic disease such as HTN, AODM, and hyperlipidemia may be included.
- •Patient is capable of giving consent.
- •Patient is willing and able to comply with the visit schedule and study procedures including follow-up visits.
- •Patient has documented CNV secondary to AMD with evidence of active disease characterized by blood vessel leakage or evidence of hemorrhage.
- •Patient has clear ocular media and adequate pupil dilation to allow good quality imaging by fundus photography.
- •Patient's intraocular pressure is ≤ 25 mmHg
排除标准
- •Patient is of childbearing potential. Every female patient is considered of child-bearing potential unless she has had sterilization surgery or is post-menopausal and has not had a menstrual period for at least 12 months.
- •Patient has CNV due to causes other than AMD, including ocular or periocular infections.
- •Patient has lesions not easily imaged and quantified.
- •Patient has underlying systemic disease such as cardiac, neurological, infectious disease, uncontrolled diabetes mellitis, or disease of the eye other than AMD. Patient may have medically controlled glaucoma.
- •Patient is participating in any concurrent interventional study.
结局指标
主要结局
To determine the safety and tolerability of PF-04523655 when administered as a single intravitreal injection
时间窗: Over a 24-Month Period
次要结局
- To describe anatomical changes in the retina and choroid following the administration of PF-04523655(Day 14)
- To evaluate early response after a single intravitreal administration of PF-04523655 in patients who, in the opinion of the investigator, have the potential to show improvement in visual acuity from other treatment options (Stratum 2 patients)(Day 14)
- To determine the changes in visual acuity ETDRS chart after a single intravitreal injection of PF-04523655(Day 14)
- To evaluate the safety, efficacy and frequency of dosing following administration of PF-04523655 of approved VEGF-inhibitors in those study patients requiring rescue therapy(Monthly)
研究者
研究点 (12)
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