Clinical Trial on Alpha Lipoic Acid in Diabetic Macular Edema (RETIPON)

September 23, 2010 updated by: Ludwig-Maximilians - University of Munich

Alpha Lipoic Acid in the Treatment of Diabetic Retinopathy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

520

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 80336
        • Department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Alpha lipoic acid 600 mg
Drug: 1,2 dithiolane 3 valeric acid
600 mg alpha lipoic acid per day
Placebo Comparator: placebo pill
Drug: 1,2 dithiolane 3 valeric acid
600 mg alpha lipoic acid per day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
The time to CSME development
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

Bausch & Lomb Incorporated

Investigators

  • Study Director: Michael W Ulbig, MD, Ludwig-Maximilians - University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2000

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

September 23, 2010

First Submitted That Met QC Criteria

September 23, 2010

First Posted (Estimate)

September 24, 2010

Study Record Updates

Last Update Posted (Estimate)

September 24, 2010

Last Update Submitted That Met QC Criteria

September 23, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMP 77.1.99

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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