NCT05358080

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 396 (estimated)
• Sponsor: Hanlim Pharm. Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Entelon Tab. 50mg	twice daily for 24months
DRUG	Placebo	twice daily for 24months

Timeline

• Start date: 2022-05-27
• Primary completion: 2024-12-16
• Completion: 2024-12-16
• First posted: 2022-05-03
• Last updated: 2022-07-21

Locations

1 site across 1 country: South Korea