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

NCT07230184 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-11-17

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • AJU Pharm Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-28
Primary Completion
2023-08-14
Completion
2024-08-16

Countries

  • South Korea

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07230184 on ClinicalTrials.gov