NCT02475109已完成1 期
A Phase 1 Open-Label, Single-Center Study to Evaluate the Safety and Tolerability of Topical Ocular PAN-90806 in Patients With Proliferative Diabetic Retinopathy (PDR)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Patients with Adverse Events
研究概览
简要总结
The objective of this study is to assess the safety and tolerability of topical ocular PAN-90806 in patients with proliferative diabetic retinopathy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older with type 1 or type 2 diabetes
- •Proliferative diabetic retinopathy (PDR) in study eye retina with or without diabetic macular edema (DME) involving the center of the macula
- •Demonstrate the ability, or have a family member who is willing and able, to instill topical ocular drops in the study eye
排除标准
- •Current or recent use (within the last 3 months) of anti-vascular endothelial growth factors (anti-VEGF) in either eye;
- •Uncontrolled hypertension despite use of antihypertensive medications
- •Unwillingness to refrain from wearing contact lenses for the duration of the study.
- •Participation in any investigational drug or device study, systemic or ocular, within past 3 months
- •Women who are pregnant or nursing
- •Known serious allergies or hypersensitivity to the fluorescein dye used in angiography or to the components of the PAN-90806 formulation
研究组 & 干预措施
PAN-90806 Ophthalmic Solution
Experimental
PAN-90806 Ophthalmic Solution taken daily for 8 weeks.
干预措施: PAN-90806 Ophthalmic Solution (Drug)
结局指标
主要结局
Number of Patients with Adverse Events
时间窗: 2 months
Safety will be assessed based upon the incidence of all adverse events, ocular and systemic
次要结局
- The mean change in best-corrected visual acuity from baseline(Week 8)
- Change in preretinal neovascularization(Week 4 and Week 8)
- The mean number of rescue treatments during the study(Week 8)
- Time to first rescue treatment(up to Week 8)
研究者
研究点 (1)
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