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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01208948
Recruitment Status : Completed
First Posted : September 24, 2010
Last Update Posted : September 24, 2010
Bausch & Lomb Incorporated
Information provided by:
Ludwig-Maximilians - University of Munich

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Macular Edema Drug: 1,2 dithiolane 3 valeric acid Phase 3

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  (Clinical Trial)
Actual Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Alpha Lipoic Acid in the Treatment of Diabetic Retinopathy
Study Start Date : July 2000
Actual Primary Completion Date : April 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

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

Primary Outcome Measures :
  1. occurrence of clinically significant macular edema (CSME) within a follow-up period of 2 years [ Time Frame: two years ]

Secondary Outcome Measures :
  1. The time to CSME development [ Time Frame: two years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01208948

Department of Ophthalmology
Munich, Germany, 80336
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Bausch & Lomb Incorporated
Study Director: Michael W Ulbig, MD Ludwig-Maximilians - University of Munich

Responsible Party: Prof. Dr. Anselm Kampik, Ludwig-Maximilians-University, Munich Identifier: NCT01208948     History of Changes
Other Study ID Numbers: DMP 77.1.99
First Posted: September 24, 2010    Key Record Dates
Last Update Posted: September 24, 2010
Last Verified: September 2010

Keywords provided by Ludwig-Maximilians - University of Munich:
macular edema
diabetes mellitus
prevention alpha lipoic acid

Additional relevant MeSH terms:
Diabetes Mellitus
Macular Edema
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Thioctic Acid
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Growth Substances