New drug combo aims to slow diabetic retinopathy
NCT ID NCT07230184
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This completed Phase 4 trial tested whether adding a second drug (B55R2) to standard treatment (B55R1) works better for people with non-proliferative diabetic retinopathy, an early stage of diabetic eye disease. 52 adults with mild to severe disease took either the combination or B55R1 alone twice daily for 24 weeks. The main goal was to see if hard exudates (fatty deposits in the eye) improved by at least one grade.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- B55R1 and B55R2 (drug combination)
- What this could lead to
- If successful, this combination could offer a better way to reduce hard exudates and control diabetic retinopathy progression.
- What could go wrong
- This is a small, completed Phase 4 trial with only 52 participants. Results may not apply to all patients, and the benefit over existing treatment may be modest.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
53 people
The number who actually took part.
- Started
-
Apr 2022
- Finished
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Aug 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
AJU Pharm Co., Ltd.
Seoul, South Korea
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