Study to Evaluate Efficacy and Safety of Entelon 50mg in Patients With Non-Proliferative Diabetic Retinopathy

NCT ID: NCT05358080

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 396 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-27
• Study Completion Date: 2024-12-16

Brief Summary

This clinical trial is a multi-center, double-blind, randomized, placebo controlled , parallel design, superiority, phase 4 study to evaluate the efficacy and safety of Entelon 50mg in 396 patients with non-proliferative diabetic retinopathy.

Detailed Description

This study is to prove that Entelon tab. 50mg is superior in clinical efficacy and safety compared to placebo for 24 months in patients suffering from non-proliferative diabetic retinopathy.

Conditions

Non Proliferative Diabetic Retinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Entelon Tab. 50mg

Group Type: EXPERIMENTAL

Entelon Tab. 50mg

Intervention Type: DRUG

twice daily for 24months

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

twice daily for 24months

Interventions

Entelon Tab. 50mg

twice daily for 24months

Intervention Type: DRUG

Placebo

twice daily for 24months

Intervention Type: DRUG

Other Intervention Names

Vitis Vinifera Seed Dreid Extract 50mg

Eligibility Criteria

Inclusion Criteria

1. 19 years ≤ age

2. Those who are diagnosed as Type 2 diabetes mellitus

3. Those whose blood sugar level has been well adjusted to less than 9% of HbA1c with dietary and oral blood sugar lowering durgs for 3 months based on the time of screening

4. Those who agree to use an effective method of contraception

5. Those who provide written consent voluntarily to participate in this clinical trial

1. Those with 0.5(20/40 Snellen lines) or more visual acuity

2. Those with 300 micrometers or less central macular thickness

3. Those who are diagnosed as mild to moderate NPDR(DRSS levels 35-47)

Exclusion Criteria

1. Those who are diagnosed as proliferative diabetic retinopathy

2. Those with macular edema

3. Diabetic subjects who have difficulty in controlling blood sugar

4. Those whose blood pressure is not well controlled at the time of the screening(>140/90mmHg)

5. Those who, have had stroke or myocardial infarction or arrhythmia that should be treated within 6 months prior to the time of screening

6. Subjects with severe renal disorder or severe liver disorder

7. Those who have a history of malignant tumors within 5 years prior to the time of screening

8. Those who are required to receive Kallidinogenase, Vaccinium myrtillus extract, Sulodexide, or Calcium dobesilate during the clinical trial period

9. Those who have an allergy to investigational product or any of its excipients

10. Those who have an allergy to fluorescein

11. Those who have galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption

12. Those who have difficulty to get OCT test or Fundus photo test

13. Pregnant or lactating woman

14. Those with medication of other investigational product within 3 months prior to the time of randomization

15. Patients who are considered to be ineligible for study participation by the investigator

1. Those who have a visual defect that can affect the evaluation determined by an investigator

2. Those who have a opacity that can affect the evaluation determined by an investigator

3. Those who have eye diseases that can affect the evaluation determined by an investigator

4. Those with 25mmHg or more intraocular pressure on a study eye

5. Those who are on medication of intravitreal injection of steroid or anti VEGF treatment or get laser photocoagulation within 6 months prior to the first administration

6. Those who have a history of a vitrectomy

7. Those who have a major ophthalmic surgery history within 3 months prior to the time of first administration for investigational products

8. Those who have a history of yttrium aluminum garnet capsulotomy within 2 months prior to the time of first administration for investigational products

9. Those with a phakia

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanlim Pharm. Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ha Kyoung Kim

Role: PRINCIPAL_INVESTIGATOR

Hallym University Kangnam Sacred Heart Hospital

Locations

Hallym University Kangnam Sacred Heart Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Ha Kyoung Kim

Role: CONTACT

ophkim@hallym.or.kr

82-2-6960-1240

Facility Contacts

Ha Kyoung Kim

Role: primary

Other Identifiers

HL-ENTL-402

Identifier Type: -

Identifier Source: org_study_id