To Evaluate the Efficacy and Safety of Combination Therapy With B55R1 and B55R2 Compared to B55R1… (NCT07230184) | Clinical Trial Compass
CompletedPhase 4
To Evaluate the Efficacy and Safety of Combination Therapy With B55R1 and B55R2 Compared to B55R1 Monotherapy in Patients With NPDR
South Korea52 participantsStarted 2022-04-28
Plain-language 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).
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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
What they're measuring
1
The proportion of subjects achieving a ≥1-step improvement in hard exudate grade at Week 24
. 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: