NCT00665106已完成1 期
A Phase I, Open-Label, Dose-Escalation Clinical Study to Assess the Safety and Tolerability of NOVA63035 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
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
- Santen SAS
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Ocular safety
研究概览
简要总结
Evaluation of safety and tolerability of a single injection of NOVA63035 "Corticosteroid" administered at one of four doses in patients with diabetic macular edema (DME) secondary to diabetic retinopathy
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
- Supportive Care
- 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
- •M & F 18 years and older
- •Diagnosed with diabetes mellitus and presenting diabetic retinopathy
排除标准
- •Monocular
- •History of current ocular hypertension or glaucoma in either eye defined
- •Any significant ocular disease (other than diabetic retinopathy)
研究组 & 干预措施
cohort 1
Experimental
5 up to 6 patients per arm. Emulsion at 0.8% of drug product.
干预措施: NOVA63035 "Corticosteroid" (Drug)
cohort 2
Experimental
5 up to 6 patients per arm. Emulsion at 0.8% of drug product.
干预措施: NOVA63035 "Corticosteroid" (Drug)
cohort 3
Experimental
5 up to 6 patients per arm. Emulsion at 3.2% of drug product.
干预措施: NOVA63035 "Corticosteroid" (Drug)
cohort 4
Experimental
5 up to 6 patients per arm. Oily solution at 3.4% of drug product.
干预措施: NOVA63035 "Corticosteroid" (Drug)
结局指标
主要结局
Ocular safety
时间窗: Over one year
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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