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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0005124

Enrollment

Registered

2020-06-15

Start date

2020-08-04

Completion date

Unknown

Last updated

2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Investigational Product(EG-Mirotin)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Ability to provide informed consent - 19 Years and older - Type 1 of type 2 Diabetes Mellitus

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
Changes in retinal nonperfusion	—

Secondary

Measure	Time frame
Progression of diabetic retinopathy to proliferative diabetic retinopathy (PDR)	—

Countries

Korea, Republic of

Contacts

Public ContactSeongjin Lee

Soon Chun Hyang University Hospital Seoul

wismile@naver.com+82-2-709-9114

Outcome results