To evaluate the effect of alpha lipoic acid (ALA) on the occurrence of diabetic macular edema.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
520
600 mg alpha lipoic acid per day
Department of Ophthalmology
Munich, Germany, Germany
occurrence of clinically significant macular edema (CSME) within a follow-up period of 2 years
Time frame: two years
The time to CSME development
Time frame: two years
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