Non Proliferative Diabetic Retinopathy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGEntelon Tab. 50mg
twice daily for 24months
DRUGPlacebo
twice daily for 24months
Sponsors
Hanlim Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 19 years ≤ age 2. Those who are diagnosed as Type 2 diabetes mellitus 3. Those whose blood sugar level has been well adjusted to less than 9% of HbA1c with dietary and oral blood sugar lowering durgs for 3 months based on the time of screening 4. Those who agree to use an effective method of contraception 5. Those who provide written consent voluntarily to participate in this clinical trial Inclusion criteria for the study eye 1. Those with 0.5(20/40 Snellen lines) or more visual acuity 2. Those with 300 micrometers or less central macular thickness 3. Those who are diagnosed as mild to moderate NPDR(DRSS levels 35-47)
Exclusion criteria
1. Those who are diagnosed as proliferative diabetic retinopathy 2. Those with macular edema 3. Diabetic subjects who have difficulty in controlling blood sugar 4. Those whose blood pressure is not well controlled at the time of the screening(\>140/90mmHg) 5. Those who, have had stroke or myocardial infarction or arrhythmia that should be treated within 6 months prior to the time of screening 6. Subjects with severe renal disorder or severe liver disorder 7. Those who have a history of malignant tumors within 5 years prior to the time of screening 8. Those who are required to receive Kallidinogenase, Vaccinium myrtillus extract, Sulodexide, or Calcium dobesilate during the clinical trial period 9. Those who have an allergy to investigational product or any of its excipients 10. Those who have an allergy to fluorescein 11. Those who have galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption 12. Those who have difficulty to get OCT test or Fundus photo test 13. Pregnant or lactating woman 14. Those with medication of other investigational product within 3 months prior to the time of randomization 15. Patients who are considered to be ineligible for study participation by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects maintained or improved in DRSS level | 24 months(Visit 10) | Change at 24 months of treatment with the drug from baseline(day 0) in DRSS(Diabetic Retinopathy Severity Scale) level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects maintained or improved or worsened in DRSS | 12 months(Visit 6), 24 months(Visit 10) | 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 |
| Amount of change BCVA letter | 24 months(Visit 10) | Amount of change in BCVA(best corrected visual acuity) letters at 24 months relative to baseline |
| Proportion of subjects improved or worsened in BCVA | 24 months(Visit 10) | 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 |
| Proportion of subjects maintained or improved in DRSS level | 12 months(Visit 6) | Change at 12 months of treatment with the drug from baseline(day 0) in DRSS(Diabetic Retinopathy Severity Scale) level |
| Change in CMT and TMV | 6 month(Visit 4), 12 month(Visit 6), 18 month(Visit 8), 24 month(Visit 10) | Amount of change in CMT(Central macular thickness) and TMV(Total macular volume) |
| Proportion of subjects with CSME | through study completion, an average of 2 years | Proportion of subjects with CSME(Clinically significant macular edema) |
| Change in quantitative of hard exudate | 6 months(Visit 4), 12 months(Visit 6), 18 months(Visit 8), 24 months(Visit 10) | Amount and rate of change in quantitative of hard exudate through fundus photo |
Countries
South Korea
Contacts
Primary ContactHa Kyoung Kim
Outcome results
None listed