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Vol. 226, No. 3, 2011
Issue release date: September 2011
Section title: EURETINA – Original Paper
Ophthalmologica 2011;226:127–137
(DOI:10.1159/000329470)

Alpha-Lipoic Acid for the Prevention of Diabetic Macular Edema

Haritoglou C. · Gerss J. · Hammes H.P. · Kampik A. · Ulbig M.W. · for the RETIPON Study Group
aDepartment of Ophthalmology, Ludwig Maximilian University, Munich, bInstitute of Biostatistics and Clinical Research, University of Münster, Münster, and c5th Medical Department, University Hospital Mannheim, Mannheim, Germany

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Article / Publication Details

First-Page Preview
Abstract of EURETINA – Original Paper

Received: 4/29/2011 2:01:50 PM
Accepted: 5/4/2011
Published online: 7/29/2011

Number of Print Pages: 11
Number of Figures: 2
Number of Tables: 5

ISSN: 0030-3755 (Print)
eISSN: 1423-0267 (Online)

For additional information: http://www.karger.com/OPH

Abstract

Introduction: To evaluate the effect of α-lipoic acid (ALA) on the occurrence of diabetic macular edema. Methods: Randomized, double-blind, placebo-controlled, multicenter, multinational study. Patients were randomized to the treatment group with 600 mg ALA per day or the placebo group. Every 6 months stereo fundus photographs, HbA1c levels, and an ophthalmological examination were documented. The primary endpoint was the occurrence of clinically significant macular edema (CSME) within a follow-up period of 2 years. Results: We randomized 235 patients with type II diabetes mellitus into the treatment group (mean age 58.0 years) and 232 into the placebo group (mean age 57.9 years). Mean HbA1c level was 8.1, with no significant differences between the treatment (mean 8.2, SD ± 1.35) and placebo groups (mean 8.1, SD ± 1.29). HbA1c values remained constant over time. In the treatment and placebo groups, 84 and 86 patients (35.7 and 37.1%) had insulin-dependent diabetes mellitus (IDDM) with a median duration of diabetes of 9.3 versus 9.0 years in the placebo group. Visual acuity remained unchanged during the entire trial. Concerning the primary endpoint, the study provided a negative result, i.e. 26/235 patients in the treatment group and 30/232 patients in the placebo group developed CSME. Confirmatory intention-to-treat analysis of the primary endpoint revealed no statistically significant difference between groups (log-rank test, p = 0.7108, HR = 0.9057 with CI = 0.5355–1.5317). Median follow-up was identical (2.00 years). Conclusions: A daily dosage of 600 mg ALA does not prevent the occurrence of CSME in IDDM patients.


  

Author Contacts

Christos Haritoglou, MD
Department of Ophthalmology, Ludwig Maximilian University
Mathildenstrasse 8
DE–80336 Munich (Germany)
Tel. +49 895 160 3084, E-Mail christos.haritoglou@med.uni-muenchen.de

  

Article Information

C.H. and J.G. contributed equally to this work.

Received: April 29, 2011
Accepted after revision: May 4, 2011
Published online: July 29, 2011
Number of Print Pages : 11
Number of Figures : 2, Number of Tables : 5, Number of References : 39

  

Publication Details

Ophthalmologica (The Journal of the European Society of Retina Specialists)

Vol. 226, No. 3, Year 2011 (Cover Date: September 2011)

Journal Editor: Cunha-Vaz J. (Coimbra)
ISSN: 0030-3755 (Print), eISSN: 1423-0267 (Online)

For additional information: http://www.karger.com/OPH


Article / Publication Details

First-Page Preview
Abstract of EURETINA – Original Paper

Received: 4/29/2011 2:01:50 PM
Accepted: 5/4/2011
Published online: 7/29/2011

Number of Print Pages: 11
Number of Figures: 2
Number of Tables: 5

ISSN: 0030-3755 (Print)
eISSN: 1423-0267 (Online)

For additional information: http://www.karger.com/OPH


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