KCT0009161招募中未知
24-week, multicenter, randomized, double blinding, placebo-controlled human application trial for evaluating the efficacy and safety of GBE for age-related macular degeneration (AMD)
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 40(Year) 至 85(Year)（—）
- 性别
- All
入选标准
- •1) A person over 40 years of age or under 85 years of age
- •2) Subjects for dry macular degeneration corresponding to Early AMD (Category 2-3) in AREDS (You can register if you meet the monocular, but if you are both eyes, you can proceed to the worse one.)
- •3) A person with at least one score of 1-4 in the subjective questionnaire for eye fatigue
- •4) A person who agrees to participate in this human body application test before the commencement of the human body application test and signs an Informed Consent Form
排除标准
- •1) If it is deemed difficult for the tester to participate in this trial as a clinically significant disease due to systemic diseases such as sepsis, meningitis, pyelonephritis, malignant tumors, renal failure, chronic obstructive pulmonary disease, heart failure, etc
- •2) A person whose central macular thickness exceeds 300 µm according to light-interference tomography of the macular region
- •3) Persons with diabetes complications of severe non-proliferative diabetic retinopathy (Moderate NPDR) or higher
- •4) A person with a history of infectious eye disease within 3 months based on visit 1
- •5) A person with a history of macular disease in either eye, a lesion with a high risk of developing wet macular degeneration, such as PED (0.5 mm or more), Retinal Hemorrahage, or a person with a confirmed geographic atrophy on the map
- •6) A person with cataracts whose cornea is so cloudy that retinal imaging is impossible
- •7) an alcoholic
- •8) Smokers (including those not more than six months after smoking)
- •9) A person who has taken hormone replacement therapy drugs within one month (30 days) based on visit 1
- •10) A person who regularly takes supplements or health functional foods related to eye health within one month (30 days) based on visit 1
- •11) A person whose creatine is more than twice the normal upper limit of the implementing agency
- •12) Those who are nearsighted at least 6 diopter as of visit 1
- •13) A person whose intraocular pressure exceeds 21 mmHg based on visit 1
- •14) A person whose AST (GOT) or ALT (GPT) is more than three times the normal upper limit of the implementing agency
- •15) Patients with uncontrolled hypertension (measured after stabilizing for 10 minutes for systolic blood pressure of 140 mmHg or more or diastolic blood pressure of 100 mmHg or more, human application test subjects)
- •16) Patients with uncontrolled hyperlipidemia (over 240 mg/dL of Total Cholesterol)
- •17) Diabetes patients whose blood sugar is not controlled (if a new drug is started due to diabetes at least 180 mg/dL of empty blood sugar or within 3 months of visit 1)
- •18) A person who is pregnant or has a plan to become pregnant during this human body application test
- •19) A person who has participated in other interventional clinical trials (including human application trials) within three months of visit 1, or plans to participate in other interventional clinical trials (including human application trials) after the start of this human application trial
- •20) A person who is sensitive or allergic to food ingredients for this human body application test
- •21) A person who judges that the tester is unsuitable for other reasons
研究者
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