Clinical Trial on Alpha Lipoic Acid in Diabetic Macular Edema

Study Overview
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Brief Summary
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To evaluate the effect of alpha lipoic acid (ALA) on the occurrence of diabetic macular edema.

Detailed Description
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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.

Official Title
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Alpha Lipoic Acid in the Treatment of Diabetic Retinopathy

Conditions
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Diabetes Mellitus, Macular Edema

Intervention / Treatment
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* Drug: 1,2 dithiolane 3 valeric acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes type II, mild non proliferative diabetic retinopathy, Microalbuminuria > 30 mg/L Exclusion Criteria: 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 Glaucoma 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alpha lipoic acid 600 mg<br> | Drug: 1,2 dithiolane 3 valeric acid<br>* 600 mg alpha lipoic acid per day<br>|
| Placebo Comparator: placebo pill<br> | Drug: 1,2 dithiolane 3 valeric acid<br>* 600 mg alpha lipoic acid per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of clinically significant macular edema (CSME) within a follow-up period of 2 years |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to CSME development |  | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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macular edema, diabetes mellitus, prevention alpha lipoic acid