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Non Proliferative Diabetic RetinopathyPhase 4NCT05358080

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

A Phase 4 study testing Entelon Tab. 50mg in people with Non Proliferative Diabetic Retinopathy, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Non Proliferative Diabetic Retinopathy
What is being tested?
Entelon Tab. 50mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
396 participants
Where
1 siteSouth Korea
Study dates
27 May 2022to 16 Dec 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 19 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)

Who cannot join

  • 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
Show all 24Show fewer
  • 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
  • Those who have a visual defect that can affect the evaluation determined by an investigator
  • Those who have a opacity that can affect the evaluation determined by an investigator
  • Those who have eye diseases that can affect the evaluation determined by an investigator
  • Those with 25mmHg or more intraocular pressure on a study eye
  • Those who are on medication of intravitreal injection of steroid or anti VEGF treatment or get laser photocoagulation within 6 months prior to the first administration
  • Those who have a history of a vitrectomy
  • Those who have a major ophthalmic surgery history within 3 months prior to the time of first administration for investigational products
  • Those who have a history of yttrium aluminum garnet capsulotomy within 2 months prior to the time of first administration for investigational products
  • Those with a phakia

Trial locations and contacts

1 site in 1 country.

Ha Kyoung Kim contact

82-2-6960-1240

ophkim@hallym.or.kr

South Korea1 site, 1 recruiting

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul

    Ha Kyoung Kim

    Recruiting

Other trials in South Korea

About this study

Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Superiority, Phase IV Trial to Evaluate the Efficacy and Safety of Entelon 50mg Compared to Placebo in Patients With Non-Proliferative Diabetic Retinopathy

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.

Read the 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.

Being tested
Entelon Tab. 50mg, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Entelon Tab. 50mgDrug

    Also called Vitis Vinifera Seed Dreid Extract 50mg

    twice daily for 24months

  • PlaceboDrug

    twice daily for 24months

Study groups in NCT05358080
Study groupRoleWhat they receive
Entelon Tab. 50mgExperimentalNot described
Receives: Drug: Entelon Tab. 50mg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24 months(Visit 10)

Secondary outcomes (7)

  1. 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

    Measured: 12 months(Visit 6)

  2. 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

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

  3. Amount of change BCVA letter

    Amount of change in BCVA(best corrected visual acuity) letters at 24 months relative to baseline

    Measured: 24 months(Visit 10)

  4. 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

    Measured: 24 months(Visit 10)

  5. Change in quantitative of hard exudate

    Amount and rate of change in quantitative of hard exudate through fundus photo

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

  6. Change in CMT and TMV

    Amount of change in CMT(Central macular thickness) and TMV(Total macular volume)

    Measured: 6 month(Visit 4), 12 month(Visit 6), 18 month(Visit 8), 24 month(Visit 10)

  7. Proportion of subjects with CSME

    Proportion of subjects with CSME(Clinically significant macular edema)

    Measured: through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2022
  2. Study start27 May 2022
  3. Primary completion16 Dec 2024 (estimated)
  4. Study completion16 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
396 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05358080
Sponsor's protocol ID
HL-ENTL-402
Status last verified
Jul 2022
First submitted
25 Apr 2022
Last updated
21 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Entelon Tab. 50mg in people with Non Proliferative Diabetic Retinopathy, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ha Kyoung Kim (82-2-6960-1240, ophkim@hallym.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects maintained or improved in DRSS level (time frame: 24 months(Visit 10)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05358080.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.

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