NCT01208948已完成3 期
Alpha Lipoic Acid in the Treatment of Diabetic Retinopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- occurrence of clinically significant macular edema (CSME) within a follow-up period of 2 years
研究概览
简要总结
To evaluate the effect of alpha lipoic acid (ALA) on the occurrence of diabetic macular edema.
详细描述
Randomised, double-blind, placebo controlled multicentre study. Patients were randomised to the treatment group with 600 mg ALA per day or the placebo group. At each examination we took stereo fundus photographs, HbA1c levels, and performed an ophthalmological examination. Primary endpoint of the study was the occurrence of clinically significant macular edema (CSME) within a follow-up period of 2 years.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes type II, mild non proliferative diabetic retinopathy,
- •Microalbuminuria > 30 mg/L
排除标准
- •Ophthalmic exclusion criteria
- •severe non-proliferative or proliferative diabetic retinopathy
- •Macular edema
- •Eye diseases interfering with the examinations of the fundus such as preretinal haemorrhage, cataract, vitreous haemorrhage
- •Amblyopia
- •Best corrected visual acuity (VA) over 0.5
- •Patients with cataract surgery within a period of three months
- •Other relevant retinal diseases
- •Non-authorized interventional therapy of diabetic retinopathy (e.g. laser, kryo-coagulation, vitrectomy)
- •General exclusion criteria
- •Chronic administration of alpha lipoic acid or of more than five successive days during the last twelve months
- •Known intolerance/hypersensitivity to alpha lipoic acid
- •Type I diabetes mellitus
- •Poor metabolic control with HbA1c >10.5 %/dl
- •Late sequelae of diabetes with organic manifestation (e.g. dialysis in cases of renal insufficiency, history of kidney transplantation, creatinine > 1.6 mg/dl)
- •Poorly controlled arterial hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 95 mmHg)
- •Severe disturbances in lipid metabolism (triglycerides > 500 mg/dl or total cholesterol > 320 mg/dl)
- •Unpermitted concomitant medication defined as any medicine with a potential interaction with alpha lipoic acid or with the effect of alpha lipoic acid were excluded as concomitant medication. These included aldose reductase inhibitors, substances promoting blood flow, anticoagulants apart from acetylsalicylic acid 500 mg/day and short-term treatment of diseases with the normal dose of acetylsalicylic acid, chronically and systemically administered corticosteroids, hormonal contraceptives
- •Malignancies or life threatening diseases
- •Drug or alcohol abuse
- •Blood donation or blood loss greater than 500 ml) within the last 3 months
- •Pregnancy or breast feeding
- •Participation in a clinical trial within the last 30 days
研究组 & 干预措施
Alpha lipoic acid 600 mg
Active Comparator
干预措施: 1,2 dithiolane 3 valeric acid (Drug)
placebo pill
Placebo Comparator
干预措施: 1,2 dithiolane 3 valeric acid (Drug)
结局指标
主要结局
occurrence of clinically significant macular edema (CSME) within a follow-up period of 2 years
时间窗: two years
次要结局
- The time to CSME development(two years)
研究者
研究点 (1)
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