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.

NCT07230184•AJU Pharm Co., Ltd.

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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).

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

Locations (1)

AJU Pharm Co., Ltd.

Seoul, South Korea

Key Dates

Start Date

April 28, 2022

Primary Completion Date

August 14, 2023

Completion Date

August 16, 2024

Last Updated

November 17, 2025

Enrollment

ACTUAL participants

Conditions

Non-Proliferative Diabetic Retinopathy

Interventions

B55R1 and B55R2

DRUG

B55R1 and placebo for B55R2

DRUG

Efficacy and Safety of Ginkgo Biloba Extract EGb761® in Patients With Diabetic Retinopathy

NCT07236645

Non-proliferative Diabetic Retinopathy (NPDR)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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