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New drug combo aims to slow diabetic retinopathy

NCT ID NCT07230184

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

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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