KCT0005124已完成未知
An Open-Label, Single-Arm, Single-center, Exploratory Phase II study to evaluate the efficacy and safety of EG-Mirotin in patients with Moderate to Severe NPDR
Eyegene0 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 0No Limit（—）
- 性别
- All
入选标准
- •Ability to provide informed consent
- •- 19 Years and older
- •- Type 1 of type 2 Diabetes Mellitus
排除标准
- •- study eye
- •? Clinically significant Glaucoma(Glaucomatous optic neuropathy, etc.), Retinal detachment and Macular degeneration that would affect visual field defects
- •? Clinically significant ocular disease except diabetic retinopathy (e.g. Retinal vein occlusion, Uveitis, any other ocular inflammatory disease, ocular cancer, etc.)
- •? Major ophthalmic surgery(cataract, glaucoma, etc.) within 3 months or scheduled for surgery before visit 9(week 8)
- •? Current ocular or ocular peripheral infection, etc.
- •- uncontrolled hypertension
- •- An arrhythmia patient who has clinically significant
- •- Severe renal disorders
- •- Severe liver disorders
- •- Medical history of malignant carcinoma within past 3 years
- •- Subjects who have hypersensitivity reaction anamnesis for components of Investigational Product.
- •- Subjects who have hypersensitivity reaction anamnesis for fluorescein
- •- Treatment with other investigational agents or devices within the previous 30 days, planned use of investigational drugs or devices, or previous enrolment in this trial
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