NCT01208948

Clinical Trial on Alpha Lipoic Acid in Diabetic Macular Edema

Alpha Lipoic Acid in the Treatment of Diabetic Retinopathy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 520 (actual)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: All
• Age: 45 Years – 68 Years
• Healthy volunteers: —

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.

Conditions

• Diabetes Mellitus
• Macular Edema

Interventions

Type	Name	Description
DRUG	1,2 dithiolane 3 valeric acid	600 mg alpha lipoic acid per day

Timeline

• Start date: 2000-07-01
• Primary completion: 2005-04-01
• Completion: 2005-12-01
• First posted: 2010-09-24
• Last updated: 2010-09-24

Locations

1 site across 1 country: Germany