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

NCT07230184 | Completed Phase 4

• 1 other identifier: 21DR40701
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  Week 4 and 12

Study Arms (2)

Test group(B55R1 and B55R2)

EXPERIMENTAL

orally twice daily

Drug: B55R1 and B55R2

Control Group(B55R1 and placebo for B55R2)

PLACEBO COMPARATOR

orally twice daily

Drug: B55R1 and placebo for B55R2

Interventions

B55R1 and B55R2 DRUG

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

Test group(B55R1 and B55R2)

B55R1 and placebo for B55R2 DRUG

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

Control Group(B55R1 and placebo for B55R2)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with proliferative diabetic retinopathy (diabetic retinopathy) or other causes of retinopathy.
• Patients with uncontrolled diabetes or uncontrolled hypertension.
• 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.
• 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
• Patients taking Kallidinogenase, Vaccinium myrtillus extract, or Sulodexide
• 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)
• Patients with severe renal impairment (renal failure requiring dialysis or (e.g., renal transplant)
• 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
• Pregnant or lactating women, or those who do not agree to use adequate contraception during the clinical trial.
• Those who have received another investigational drug within 12 weeks prior to Visit 1
• Those who are judged by the investigator to be unsuitable for clinical trial participation due to other clinically significant medical or psychiatric findings

Sponsors & Collaborators

• AJU Pharm Co., Ltd.: lead

Study Sites (1)

AJU Pharm Co., Ltd.

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: November 17, 2025
• Study Start: April 28, 2022
• Primary Completion: August 14, 2023
• Study Completion: August 16, 2024
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

KR (1)