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
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0005124
- Lead Sponsor
- Eyegene
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
Ability to provide informed consent
- 19 Years and older
- Type 1 of type 2 Diabetes Mellitus
- 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in retinal nonperfusion
- Secondary Outcome Measures
Name Time Method Progression of diabetic retinopathy to proliferative diabetic retinopathy (PDR)