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

Hanlim Pharm. Co., Ltd.1 site in 1 country396 target enrollmentMay 27, 2022

ConditionsNon Proliferative Diabetic Retinopathy

InterventionsEntelon Tab. 50mg Placebo

DrugsEntelon Tab. 50mg Placebo

Overview

Phase: Phase 4
Intervention: Entelon Tab. 50mg
Conditions: Non Proliferative Diabetic Retinopathy
Sponsor: Hanlim Pharm. Co., Ltd.
Enrollment: 396
Locations: 1
Primary Endpoint: Proportion of subjects maintained or improved in DRSS level
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 27, 2022

End Date

December 16, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hanlim Pharm. Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•19 years ≤ age
•Those who are diagnosed as Type 2 diabetes mellitus
•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
•Those who agree to use an effective method of contraception
•Those who provide written consent voluntarily to participate in this clinical trial
•Inclusion criteria for the study eye
•Those with 0.5(20/40 Snellen lines) or more visual acuity
•Those with 300 micrometers or less central macular thickness
•Those who are diagnosed as mild to moderate NPDR(DRSS levels 35-47)

Exclusion Criteria

•Those who are diagnosed as proliferative diabetic retinopathy
•Those with macular edema
•Diabetic subjects who have difficulty in controlling blood sugar
•Those whose blood pressure is not well controlled at the time of the screening(\>140/90mmHg)
•Those who, have had stroke or myocardial infarction or arrhythmia that should be treated within 6 months prior to the time of screening
•Subjects with severe renal disorder or severe liver disorder
•Those who have a history of malignant tumors within 5 years prior to the time of screening
•Those who are required to receive Kallidinogenase, Vaccinium myrtillus extract, Sulodexide, or Calcium dobesilate during the clinical trial period
•Those who have an allergy to investigational product or any of its excipients
•Those who have an allergy to fluorescein

Arms & Interventions

Entelon Tab. 50mg

Intervention: Entelon Tab. 50mg

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Proportion of subjects maintained or improved in DRSS level

Time Frame: 24 months(Visit 10)

Change at 24 months of treatment with the drug from baseline(day 0) in DRSS(Diabetic Retinopathy Severity Scale) level

Secondary Outcomes

Proportion of subjects maintained or improved or worsened in DRSS(12 months(Visit 6), 24 months(Visit 10))
Amount of change BCVA letter(24 months(Visit 10))
Proportion of subjects improved or worsened in BCVA(24 months(Visit 10))
Change in quantitative of hard exudate(6 months(Visit 4), 12 months(Visit 6), 18 months(Visit 8), 24 months(Visit 10))
Change in CMT and TMV(6 month(Visit 4), 12 month(Visit 6), 18 month(Visit 8), 24 month(Visit 10))
Proportion of subjects with CSME(through study completion, an average of 2 years)
Proportion of subjects maintained or improved in DRSS level(12 months(Visit 6))