This is a study aiming to assess the efficacy and safety of Keluo Xin capsule in patients with moderately severe to severe nonproliferative diabetic retinopathy (NPDR). Two-thirds of participates will receive Keluo Xin capsules while other one third will receive placebo.
This study composes two parts. The first is a 24-week period during which subjects receive designed treatment regimen; after that, subjects will be informed again for the next 24-week regimen (extention phase) and can choose whether or not to participate in the treatment (with the same regimen in the first period) voluntarily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
198
four capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.
four placebo capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.
Mean change from DR severity as measured by the early treatment diabetic retinopathy score chart at 24 weeks
Based on the classification criteria of Early Treatment of Diabetic Retinopathy Study to grade DR severity.
Time frame: Baseline and 24 weeks
Mean change from DR severity as measured by the early treatment diabetic retinopathy score chart at 48 weeks
Based on the classification criteria of Early Treatment of Diabetic Retinopathy Study to grade DR severity.
Time frame: Baseline and 48 weeks
Pathological changes from baseline at 24 weeks as measured by optical coherence tomography (OCT) .
Time frame: Baseline and 24 weeks
Pathological changes from baseline at 48 weeks as measured by optical coherence tomography (OCT) .
Time frame: Baseline and 48 weeks
Pathological changes from baseline at 24 weeks as measured by fluorescence angiography (FFA).
Time frame: Baseline and 24 weeks
Pathological changes from baseline at 48 weeks as measured by fluorescence angiography (FFA).
Time frame: Baseline and 48 weeks
Mean change from baseline in Chinese medicine syndrome score chart at 24 weeks
The score chart is based on the typical symptoms and signs both in the eye and whole body on patients with DR and is used to assess DR severity.
Time frame: Baseline and 24 weeks
Mean change from baseline in Chinese medicine syndrome score chart at 48 weeks
The score chart is based on the typical symptoms and signs both in the eye and whole body on patients with DR and is used to assess DR severity.
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Time frame: Baseline and 48 weeks
Mean change from baseline in best corrected visual acuity at 24 weeks
Visual acuity is assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
Time frame: Baseline and 24 weeks
Mean change from baseline in best corrected visual acuity at 48 weeks
Visual acuity is assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
Time frame: Baseline and 48 weeks
Frequency and severity of ocular and non-ocular adverse events over time
Time frame: Screening to 24 weeks and 48 weeks