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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entelon Tab. 50mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entelon Tab. 50mg | Drug | twice daily for 24months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion 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 | 24 months(Visit 10) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months(Visit 6) |
| Proportion of subjects maintained or improved or worsened in DRSS |
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Inclusion Criteria:
Inclusion criteria for the study eye
Exclusion Criteria:
Exclusion criteria for the study eye
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ha Kyoung Kim | Contact | 82-2-6960-1240 | ophkim@hallym.or.kr |
| Name | Affiliation | Role |
|---|---|---|
| Ha Kyoung Kim | Hallym University Kangnam Sacred Heart Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Kangnam Sacred Heart Hospital | Recruiting | Seoul | South Korea |
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| Placebo | Drug | twice daily for 24months |
|
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 |
| 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 | 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 | 24 months(Visit 10) |
| Change in quantitative of hard exudate | Amount and rate of change in quantitative of hard exudate through fundus photo | 6 months(Visit 4), 12 months(Visit 6), 18 months(Visit 8), 24 months(Visit 10) |
| Change in CMT and TMV | Amount of change in CMT(Central macular thickness) and TMV(Total macular volume) | 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) | through study completion, an average of 2 years |