Non-Proliferative Diabetic RetinopathyPhase 4NCT07230184
To Evaluate the Efficacy and Safety of Combination Therapy With B55R1 and B55R2 Compared to B55R1 Monotherapy in Patients With NPDR
A Phase 4 study testing B55R1 and B55R2 in people with Non-Proliferative Diabetic Retinopathy, run by AJU Pharm Co., Ltd. at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Non-Proliferative Diabetic Retinopathy
- What is being tested?
- B55R1 and B55R2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Apr 2022to 16 Aug 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Non-Proliferative Diabetic Retinopathy
- Being tested
- B55R1 and B55R2, B55R1 and placebo for B55R2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B55R1 and B55R2Drug
After Randomization(Week 0), Participants will be administered with the drug, 2 times in a day, until end of trial(Week 24).
B55R1 and placebo for B55R2Drug
After Randomization(Week 0), Participants will be administered with the drug, 2 times in a day, until end of trial(Week 24).
| Study group | Role | What they receive |
|---|---|---|
| Test group(B55R1 and B55R2) | Experimental | orally twice daily Receives: Drug: B55R1 and B55R2 |
| Control Group(B55R1 and placebo for B55R2) | Placebo comparator | orally twice daily Receives: Drug: B55R1 and placebo for B55R2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 24
Secondary outcomes (2)
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
Measured: 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
Measured: Week 4 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start28 Apr 2022
- Primary completion14 Aug 2023
- Study completion16 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- AJU Pharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230184
- Sponsor's protocol ID
- 21DR40701
- Status last verified
- Nov 2025
- First submitted
- 22 Sep 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07230184
- Acronym / sponsor ID
- 21DR40701
- Conditions
- Non-Proliferative Diabetic Retinopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- AJU Pharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group(B55R1 and B55R2) | Experimental | Drug: B55R1 and B55R2orally twice daily |
| Control Group(B55R1 and placebo for B55R2) | Placebo comparator | Drug: B55R1 and placebo for B55R2orally twice daily |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (14 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B55R1 and B55R2After Randomization(Week 0), Participants will be administered with the drug, 2 times in a day, until end of trial(Week 24). | Drug | Test group(B55R1 and B55R2) |
| B55R1 and placebo for B55R2After Randomization(Week 0), Participants will be administered with the drug, 2 times in a day, until end of trial(Week 24). | Drug | Control Group(B55R1 and placebo for B55R2) |
Primary outcome
The proportion of subjects achieving a ≥1-step improvement in hard exudate grade at Week 24
Time frame: Week 24
The proportion of subjects achieving a ≥1-step improvement in hard exudate grade at Week 24
2 secondary outcomes
Changes in CMT as measured by OCT at Week 4, 12 and 24
Time frame: Week 4, 12 and 24
The proportion of subjects achieving a ≥1-step improvement in hard exudate grade at Week 4 and 12
Time frame: Week 4 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
Related trials for Non-Proliferative Diabetic Retinopathy
Recruiting
To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity. Assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists
Proliferative Diabetic Retinopathy (PDR)
RecruitingPhase 2/3
Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
Diabetic Retinopathy
RecruitingPhase 2
A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy
Diabetic Retinopathy
Active, not recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Orally Administered VX-01
Diabetic Retinopathy, NPDR - Non Proliferative Diabetic Retinopathy
RecruitingPhase 1
A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.
Diabetic Macular Edema, Diabetic Retinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing B55R1 and B55R2 in people with Non-Proliferative Diabetic Retinopathy, run by AJU Pharm Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects achieving a ≥1-step improvement in hard exudate grade at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.