NCT07230184

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

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: AJU Pharm Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Non-Proliferative Diabetic Retinopathy

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2022-04-28
• Primary completion: 2023-08-14
• Completion: 2024-08-16
• First posted: 2025-11-17
• Last updated: 2025-11-17

Locations

1 site across 1 country: South Korea