NCT07269704已完成1 期
Effect of Nutritional Supplement Alpha-ketoglutarate for Age-related Ocular Disease: An Open Label, Single Arm Study to Evaluate the Effect of Alpha-ketoglutarate Administered Orally in Patients With Age-related Ocular Diseases (Metabolic Eye Therapy)
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Mean change in aqueous humor aKG concentration
研究概览
简要总结
The aims of the study are as follows:
- Determine how the eye absorbs supplements taken orally.
- Look for specific signs in the proteins and substances in the eyes of people with eye diseases who are also taking nutritional supplements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to give written informed consent
- •Able to attend all study visits and complete the study procedures
- •Women of child-bearing potential must have a negative pregnancy test within 2 weeks before cataract surgery. A pregnancy test is not required for postmenopausal women (defined as being at least 12 consecutive months without menses) or those surgically sterilized (those having a bilateral tubal ligation/bilateral salpingectomy, bilateral tubal occlusive procedure, hysterectomy, or bilateral oophorectomy).
排除标准
- •Diabetes and/or thyroid, liver, kidney, bowel, and metabolic diseases or disorders
- •History of supplement allergy or planned major surgery
- •Received any other clinical trial drug within 4 months
- •Calculated creatinine clearance of less than 30 ml/min
研究组 & 干预措施
Calcium alpha-ketoglutarate (Ca-aKG)
Experimental
At the first and second cataract surgery of the participant, a small amount of tissue (eye fluid ~0.1 ml or 1-2 drops) is removed for analysis. Beginning one week (7 days) prior to their second cataract extraction surgery, the patient takes an oral nutritional supplement (calcium alpha-ketoglutarate) 2 times a day.
干预措施: Calcium alpha-ketoglutarate (Drug)
结局指标
主要结局
Mean change in aqueous humor aKG concentration
时间窗: Baseline and post-supplementation, approximately 28 days
To evaluate the mean difference in fold-change in aKG levels from baseline to post-supplementation in eye fluid
次要结局
- Mean fold-change in metabolic and retinal pathways(Baseline and post-supplementation, approximately 28 days)
研究者
Vinit Mahajan
Professor of Ophthalmology
Stanford University
研究点 (1)
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