Clinical Trial on Alpha Lipoic Acid in Diabetic Macular Edema

Phase 3

Completed

• Conditions: Diabetes Mellitus; Macular Edema
• Interventions: Drug: 1,2 dithiolane 3 valeric acid

• Registration Number: NCT01208948
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2000-07
• Primary Completion: 2005-04
• Study Completion: 2005-12
• Status Verified: 2010-09
• Study First Submitted: 2010-09-23
• Study First Submitted QC: 2010-09-23
• Last Update Submitted: 2010-09-23
• Study First Posted: 2010-09-24
• Last Update Posted: 2010-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alpha lipoic acid 600 mg	1,2 dithiolane 3 valeric acid	-
placebo pill	1,2 dithiolane 3 valeric acid	-

Primary Outcome Measures

Name	Time	Method
occurrence of clinically significant macular edema (CSME) within a follow-up period of 2 years	two years

Secondary Outcome Measures

Name	Time	Method
The time to CSME development	two years

Trial Locations

Locations (1)

Department of Ophthalmology; 🇩🇪 Munich, Germany