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

Korábbi kezelés

• 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 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)
• Those who have received another investigational drug within 12 weeks prior to Visit 1

Más betegség

• 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 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
• Those who are judged by the investigator to be unsuitable for clinical trial participation due to other clinically significant medical or psychiatric findings

Egyéb

• Patients with proliferative diabetic retinopathy (diabetic retinopathy) or other causes of retinopathy.
• Patients taking Kallidinogenase, Vaccinium myrtillus extract, or Sulodexide
• Pregnant or lactating women, or those who do not agree to use adequate contraception during the clinical trial.

• 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.