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.

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).

Study Overview

• Status: Completed
• Conditions: Non-Proliferative Diabetic Retinopathy
• Intervention / Treatment: Drug: B55R1 and B55R2; Drug: B55R1 and placebo for B55R2

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • AJU Pharm Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects aged 19 years or older as of the date of written consent.
2. Patients diagnosed with type 1 or type 2 diabetes.
3. Subjects with mild to severe nonproliferative diabetic retinopathy (diabetic retinopathy), grade 2-5 hard exudates
4. Subjects with a best-corrected visual acuity (BCVA) of 0.33 or higher as determined by visual acuity testing.
5. Subjects with a central retinal thickness of 350 µm or less as determined by optical coherence tomography (OCT).
6. Subjects who have received an explanation of the purpose and methods of this clinical trial and voluntarily consented to participate.

Exclusion Criteria:

1. Patients with proliferative diabetic retinopathy (diabetic retinopathy) or other causes of retinopathy.
2. Patients with uncontrolled diabetes or uncontrolled hypertension.

3. Patients with the following ocular diseases or surgical procedures:

   - Visual field defects, media opacity and ocular diseases other than diabetic retinopathywhich the investigator determines may affect the evaluation.

4. Patients who have received intravitreal and periocular steroid injections, intravitreal injection of anti-VEGF antibodies (anti-VEGF treatment), or laser photocoagulation within 12 weeks of the date of administration of the investigational drug
5. Patients taking Kallidinogenase, Vaccinium myrtillus extract, or Sulodexide
6. Patients who have experienced a cardiovascular event (unstable angina, myocardial infarction, transient ischemic attack, stroke, etc.) within 24 weeks prior to Visit 1 (participation is possible if the event occurred 24 weeks prior to Visit 1 and the patient is currently receiving medication in a stable condition)
7. Patients with severe renal impairment (renal failure requiring dialysis or (e.g., renal transplant)

8. Patients with a history of malignancy within the past 5 years from the time of screening. However, the following are eligible for clinical trial participation:

   • More than 5 years have passed since the cancer was diagnosed as cured from the screening.
   • Basal cell carcinoma, squamous cell carcinoma of the skin, thyroid cancer, or other intraepithelial neoplasms
9. Pregnant or lactating women, or those who do not agree to use adequate contraception during the clinical trial.
10. Those who have received another investigational drug within 12 weeks prior to Visit 1
11. Those who are judged by the investigator to be unsuitable for clinical trial participation due to other clinically significant medical or psychiatric findings

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group(B55R1 and B55R2); orally twice daily	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).
Placebo Comparator: Control Group(B55R1 and placebo for B55R2); orally twice daily	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects achieving a ≥1-step improvement in hard exudate grade at Week 24	The proportion of subjects achieving a ≥1-step improvement in hard exudate grade at Week 24	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in CMT as measured by OCT at Week 4, 12 and 24	Changes in CMT as measured by OCT at Week 4, 12 and 24	Week 4, 12 and 24
The proportion of subjects achieving a ≥1-step improvement in hard exudate grade at Week 4 and 12	The proportion of subjects achieving a ≥1-step improvement in hard exudate grade at Week 4 and 12	Week 4 and 12

Collaborators and Investigators

• Sponsor: AJU Pharm Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2022
• Primary Completion (Actual): August 14, 2023
• Study Completion (Actual): August 16, 2024

Study Registration Dates

• First Submitted: September 22, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 21DR40701

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No