Clinical Trial on Alpha Lipoic Acid in Diabetic Macular Edema

Alpha Lipoic Acid in the Treatment of Diabetic Retinopathy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01208948

Acronym

RETIPON

Enrollment

520

Registered

2010-09-24

Start date

2000-07-31

Completion date

2005-12-31

Last updated

2010-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Macular Edema

Keywords

macular edema, diabetes mellitus, prevention alpha lipoic acid

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.

Interventions

DRUG1,2 dithiolane 3 valeric acid

600 mg alpha lipoic acid per day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to 68 Years

Inclusion criteria

* Diabetes type II, mild non proliferative diabetic retinopathy, * Microalbuminuria \> 30 mg/L

Exclusion criteria

Ophthalmic

Design outcomes

Primary

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

Secondary

Measure	Time frame
The time to CSME development	two years

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026