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

A Multi-center, Randomized, Double-blind, Placebo-controlled, Superiority, Phase IV Trial to Evaluate the Efficacy and Safety of Entelon 50mg Compared to Placebo in Patients With Non-Proliferative Diabetic Retinopathy

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.

Study Overview

• Status: Recruiting
• Conditions: Non Proliferative Diabetic Retinopathy
• Intervention / Treatment: Drug: Entelon Tab. 50mg; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 396
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ha Kyoung Kim; Phone Number: 82-2-6960-1240; Email: ophkim@hallym.or.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Hallym University Kangnam Sacred Heart Hospital
    • Contact: Ha Kyoung Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Inclusion criteria for the study eye

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

Exclusion criteria for the study eye

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; twice daily for 24months
Experimental: Entelon Tab. 50mg	Drug: Entelon Tab. 50mg; twice daily for 24months; Other Names: Vitis Vinifera Seed Dreid Extract 50mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects maintained or improved in DRSS level	Change at 24 months of treatment with the drug from baseline(day 0) in DRSS(Diabetic Retinopathy Severity Scale) level	24 months(Visit 10)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects maintained or improved in DRSS level	Change at 12 months of treatment with the drug from baseline(day 0) in DRSS(Diabetic Retinopathy Severity Scale) level	12 months(Visit 6)
Proportion of subjects maintained or improved or worsened in DRSS	Percentage of subjects with no change in DRSS(diabetic retinopathy severity scale) compared to baseline at 12 or 24 months compared to baseline, improved one or more levels, improved two or more levels, worsened one or more levels, and worsened two or more levels	12 months(Visit 6), 24 months(Visit 10)
Amount of change BCVA letter	Amount of change in BCVA(best corrected visual acuity) letters at 24 months relative to baseline	24 months(Visit 10)
Proportion of subjects improved or worsened in BCVA	Proportion of subjects with improved five or more letters in BCVA(best corrected visual acuity) and worsened five or more letters at 24 months compared to baseline	24 months(Visit 10)
Change in quantitative of hard exudate	Amount and rate of change in quantitative of hard exudate through fundus photo	6 months(Visit 4), 12 months(Visit 6), 18 months(Visit 8), 24 months(Visit 10)
Change in CMT and TMV	Amount of change in CMT(Central macular thickness) and TMV(Total macular volume)	6 month(Visit 4), 12 month(Visit 6), 18 month(Visit 8), 24 month(Visit 10)
Proportion of subjects with CSME	Proportion of subjects with CSME(Clinically significant macular edema)	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Hanlim Pharm. Co., Ltd.
• Investigators: Principal Investigator: Ha Kyoung Kim, Hallym University Kangnam Sacred Heart Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2022
• Primary Completion (Anticipated): December 16, 2024
• Study Completion (Anticipated): December 16, 2024

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: HL-ENTL-402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No