This clinical trial is a multi-center, double-blind, randomized, placebo controlled , parallel design, superiority, phase 4 study to evaluate the efficacy and safety of Entelon 50mg in 396 patients with non-proliferative diabetic retinopathy.
This study is to prove that Entelon tab. 50mg is superior in clinical efficacy and safety compared to placebo for 24 months in patients suffering from non-proliferative diabetic retinopathy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
396
twice daily for 24months
twice daily for 24months
Hallym University Kangnam Sacred Heart Hospital
Seoul, South Korea
RECRUITINGProportion of subjects maintained or improved in DRSS level
Change at 24 months of treatment with the drug from baseline(day 0) in DRSS(Diabetic Retinopathy Severity Scale) level
Time frame: 24 months(Visit 10)
Proportion of subjects maintained or improved in DRSS level
Change at 12 months of treatment with the drug from baseline(day 0) in DRSS(Diabetic Retinopathy Severity Scale) level
Time frame: 12 months(Visit 6)
Proportion of subjects maintained or improved or worsened in DRSS
Percentage of subjects with no change in DRSS(diabetic retinopathy severity scale) compared to baseline at 12 or 24 months compared to baseline, improved one or more levels, improved two or more levels, worsened one or more levels, and worsened two or more levels
Time frame: 12 months(Visit 6), 24 months(Visit 10)
Amount of change BCVA letter
Amount of change in BCVA(best corrected visual acuity) letters at 24 months relative to baseline
Time frame: 24 months(Visit 10)
Proportion of subjects improved or worsened in BCVA
Proportion of subjects with improved five or more letters in BCVA(best corrected visual acuity) and worsened five or more letters at 24 months compared to baseline
Time frame: 24 months(Visit 10)
Change in quantitative of hard exudate
Amount and rate of change in quantitative of hard exudate through fundus photo
Time frame: 6 months(Visit 4), 12 months(Visit 6), 18 months(Visit 8), 24 months(Visit 10)
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Change in CMT and TMV
Amount of change in CMT(Central macular thickness) and TMV(Total macular volume)
Time frame: 6 month(Visit 4), 12 month(Visit 6), 18 month(Visit 8), 24 month(Visit 10)
Proportion of subjects with CSME
Proportion of subjects with CSME(Clinically significant macular edema)
Time frame: through study completion, an average of 2 years