NCT05358080

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
396

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2022

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
24 days until next milestone

Study Start

First participant enrolled

May 27, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2024

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

2.6 years

First QC Date

April 25, 2022

Last Update Submit

July 19, 2022

Conditions

Non Proliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (7)

  • Proportion of subjects maintained or improved in DRSS level

    12 months(Visit 6)

  • Proportion of subjects maintained or improved or worsened in DRSS

    12 months(Visit 6), 24 months(Visit 10)

  • Amount of change BCVA letter

    24 months(Visit 10)

  • Proportion of subjects improved or worsened in BCVA

    24 months(Visit 10)

  • Change in quantitative of hard exudate

    6 months(Visit 4), 12 months(Visit 6), 18 months(Visit 8), 24 months(Visit 10)

  • +2 more secondary outcomes

Study Arms (2)

Entelon Tab. 50mg

EXPERIMENTAL
Drug: Entelon Tab. 50mg

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Entelon Tab. 50mgDRUG

twice daily for 24months

Also known as: Vitis Vinifera Seed Dreid Extract 50mg
Entelon Tab. 50mg
PlaceboDRUG

twice daily for 24months

Placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years ≤ age
  • Those who are diagnosed as Type 2 diabetes mellitus
  • 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
  • Those who agree to use an effective method of contraception
  • Those who provide written consent voluntarily to participate in this clinical trial
  • Those with 0.5(20/40 Snellen lines) or more visual acuity
  • Those with 300 micrometers or less central macular thickness
  • Those who are diagnosed as mild to moderate NPDR(DRSS levels 35-47)

You may not qualify if:

  • Those who are diagnosed as proliferative diabetic retinopathy
  • Those with macular edema
  • Diabetic subjects who have difficulty in controlling blood sugar
  • Those whose blood pressure is not well controlled at the time of the screening(\>140/90mmHg)
  • Those who, have had stroke or myocardial infarction or arrhythmia that should be treated within 6 months prior to the time of screening
  • Subjects with severe renal disorder or severe liver disorder
  • Those who have a history of malignant tumors within 5 years prior to the time of screening
  • Those who are required to receive Kallidinogenase, Vaccinium myrtillus extract, Sulodexide, or Calcium dobesilate during the clinical trial period
  • Those who have an allergy to investigational product or any of its excipients
  • Those who have an allergy to fluorescein
  • Those who have galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption
  • Those who have difficulty to get OCT test or Fundus photo test
  • Pregnant or lactating woman
  • Those with medication of other investigational product within 3 months prior to the time of randomization
  • Patients who are considered to be ineligible for study participation by the investigator
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hallym University Kangnam Sacred Heart Hospital

Seoul, South Korea

RECRUITING

Study Officials

  • Ha Kyoung Kim

    Hallym University Kangnam Sacred Heart Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ha Kyoung Kim

CONTACT

82-2-6960-1240ophkim@hallym.or.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2022

First Posted

May 3, 2022

Study Start

May 27, 2022

Primary Completion

December 16, 2024

Study Completion

December 16, 2024

Last Updated

July 21, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)