Study to Evaluate Efficacy and Safety of Entelon 50mg in Patients With Non-Proliferative Diabetic Retinopathy

Last updated: July 19, 2022
Sponsor: Hanlim Pharm. Co., Ltd.
Overall Status: Active - Recruiting

Phase

4

Condition

Retina

Diabetic Retinopathy

Treatment

N/A

Clinical Study ID

NCT05358080
HL-ENTL-402
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 withdietary and oral blood sugar lowering durgs for 3 months based on the time ofscreening
  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
  6. Those with 0.5(20/40 Snellen lines) or more visual acuity
  7. Those with 300 micrometers or less central macular thickness
  8. Those who are diagnosed as mild to moderate NPDR(DRSS levels 35-47)

Exclusion

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 thescreening(>140/90mmHg)
  5. Those who, have had stroke or myocardial infarction or arrhythmia that should betreated 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 ofscreening
  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-galactosemalabsorption
  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 thetime of randomization
  15. Patients who are considered to be ineligible for study participation by theinvestigator Exclusion criteria for the study eye
  16. Those who have a visual defect that can affect the evaluation determined by aninvestigator
  17. Those who have a opacity that can affect the evaluation determined by an investigator
  18. Those who have eye diseases that can affect the evaluation determined by aninvestigator
  19. Those with 25mmHg or more intraocular pressure on a study eye
  20. Those who are on medication of intravitreal injection of steroid or anti VEGFtreatment or get laser photocoagulation within 6 months prior to the firstadministration
  21. Those who have a history of a vitrectomy
  22. Those who have a major ophthalmic surgery history within 3 months prior to the time offirst administration for investigational products
  23. Those who have a history of yttrium aluminum garnet capsulotomy within 2 months priorto the time of first administration for investigational products
  24. Those with a phakia

Study Design

Total Participants: 396
Study Start date:
May 27, 2022
Estimated Completion Date:
December 16, 2024

Study 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.

Connect with a study center

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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