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COMPLETED
NCT07230184
PHASE4

To Evaluate the Efficacy and Safety of Combination Therapy With B55R1 and B55R2 Compared to B55R1 Monotherapy in Patients With NPDR

Sponsor: AJU Pharm Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is planned to evaluate the efficacy and safety of combination therapy with B55R1 and B55R2 compared to B55R1 monotherapy in patients with non-proliferative diabetic retinopathy (NPDR).

Official title: To Evaluate the Efficacy and Safety of Combination Therapy With B55R1 and B55R2 Compared to B55R1 Monotherapy in Patients With Non-proliferative Diabetic Retinopathy (NPDR), Focusing on Changes in Hard Exudates (HE) Over 24 Weeks.

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

53

Start Date

2022-04-28

Completion Date

2024-08-16

Last Updated

2026-09-04

Healthy Volunteers

No

Interventions

DRUG

B55R1 and B55R2

After Randomization(Week 0), Participants will be administered with the drug, 2 times in a day, until end of trial(Week 24).

DRUG

B55R1 and placebo for B55R2

After Randomization(Week 0), Participants will be administered with the drug, 2 times in a day, until end of trial(Week 24).

Locations (1)

AJU Pharm Co., Ltd.

Seoul, South Korea