Clinical trial NCT05358080: Study to Evaluate Efficacy and Safety of Entelon 50mg in Patients With Non-Proliferative Diabetic Retinopathy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non Proliferative Diabetic Retinopathy
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-03
Enrollment: 396
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Exclusion criteria for the study eye

1. Those who have a visual defect that can affect the evaluation determined by an investigator
2. Those who have a opacity that can affect the evaluation determined by an investigator
3. Those who have eye diseases that can affect the evaluation determined by an investigator
4. Those with 25mmHg or more intraocular pressure on a study eye
5. 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
6. Those who have a history of a vitrectomy
7. Those who have a major ophthalmic surgery history within 3 months prior to the time of first administration for investigational products
8. Those who have a history of yttrium aluminum garnet capsulotomy within 2 months prior to the time of first administration for investigational products
9. Those with a phakia

Primary outcomes:
measure: Proportion of subjects maintained or improved in DRSS level
timeFrame: 24 months(Visit 10)
Secondary outcomes:
measure: Proportion of subjects maintained or improved in DRSS level
timeFrame: 12 months(Visit 6)
measure: Proportion of subjects maintained or improved or worsened in DRSS
timeFrame: 12 months(Visit 6), 24 months(Visit 10)
measure: Amount of change BCVA letter
timeFrame: 24 months(Visit 10)
measure: Proportion of subjects improved or worsened in BCVA
timeFrame: 24 months(Visit 10)
measure: Change in quantitative of hard exudate
timeFrame: 6 months(Visit 4), 12 months(Visit 6), 18 months(Visit 8), 24 months(Visit 10)
measure: Change in CMT and TMV
timeFrame: 6 month(Visit 4), 12 month(Visit 6), 18 month(Visit 8), 24 month(Visit 10)
measure: Proportion of subjects with CSME
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
Study officials:
affiliation: Hallym University Kangnam Sacred Heart Hospital
name: Ha Kyoung Kim
role: PRINCIPAL_INVESTIGATOR
References: