Efficacy of Nutritional Supplements Alzer® and Diamel® to Prevent Severe Diabetes Macular Edema. Clinical Trial Phase II.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Macular retinal thickness
研究概览
简要总结
Macular edema is the main cause of low vision in diabetics. They continue looking for new treatment alternatives. The nutritional supplement Alzer, is a powerful antioxidant that together with Diamel, a supplement that has shown efficacy in metabolic control, could be a therapeutic option. Objective: To evaluate the therapeutic efficacy of the Alzer Diamel combination in mild and moderate macular edema. Material and method: A randomized double-blind phase II clinical trial versus placebo will be conducted in 64 patients, who will be randomly assigned to two groups, one will receive Alzer + Diamel and another will receive placebo from Alzer and Diamel. All patients will undergo clinical, biochemical and ophthalmological evaluation during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetics type 2 insulin treated.
- •Age between 18 and 65 years.
- •Glycosylated hemoglobin (HB A1c) <8% at the beginning of the investigation.
- •Patients who express written voluntariness to enter the study with their signature of the informed consent document.
- •If woman of childbearing age, negative pregnancy test and use of barrier contraceptives.
排除标准
- •Pregnancy and lactation.
- •Age over 65 years.
- •Macular edema with vitreous-retinal traction or other cause (renal, arterial hypertension, post-surgical).
- •Opacity of the refractive media that hinders the ophthalmological examination.
- •History of hypersensitivity to another similar product or one of its components.
- •Patients at potential risk of not compliance the study (those who will travel during the period of the investigation or distance in their residence, outside the city).
- •Subjects who are participating in another clinical trial Patients with cognitive disorders or a mental disorder that hinders their follow-up.
结局指标
主要结局
Macular retinal thickness
时间窗: 1 year
macular retinal measure
次要结局
- Visual acuity(1 year)