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

Aju Pharm

Status and phase: Completed; Phase 4

Conditions: Non-Proliferative Diabetic Retinopathy

Treatments: Drug: B55R1 and B55R2; Drug: B55R1 and placebo for B55R2

Study type: Interventional

Funder types: Industry

Identifiers

NCT07230184

21DR40701

Details and patient eligibility

About

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).

Enrollment: 52 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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.
   • 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

Test group(B55R1 and B55R2)

Experimental group

Description:

orally twice daily

Treatment:

Drug: B55R1 and B55R2

Control Group(B55R1 and placebo for B55R2)

Placebo Comparator group

Description:

orally twice daily

Treatment:

Drug: B55R1 and placebo for B55R2