NCT05358080招募中4 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 396
- 试验地点
- 1
- 主要终点
- Proportion of subjects maintained or improved in DRSS level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Inclusion criteria for the study eye
- •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)
排除标准
- •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
- •Exclusion criteria for the study eye
- •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
研究组 & 干预措施
Entelon Tab. 50mg
Experimental
干预措施: Entelon Tab. 50mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects maintained or improved in DRSS level
时间窗: 24 months(Visit 10)
Change at 24 months of treatment with the drug from baseline(day 0) in DRSS(Diabetic Retinopathy Severity Scale) level
次要结局
- 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))
- Change in CMT and TMV(6 month(Visit 4), 12 month(Visit 6), 18 month(Visit 8), 24 month(Visit 10))
- Proportion of subjects with CSME(through study completion, an average of 2 years)
- Proportion of subjects maintained or improved in DRSS level(12 months(Visit 6))
研究者
研究点 (1)
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