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

This study has been completed.
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01208948
First received: September 23, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Alpha Lipoic Acid in the Treatment of Diabetic Retinopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • occurrence of clinically significant macular edema (CSME) within a follow-up period of 2 years [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The time to CSME development [ Time Frame: two years ] [ Designated as safety issue: No ]

Enrollment: 520
Study Start Date: July 2000
Study Completion Date: December 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years to 68 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01208948

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

No publications provided

Responsible Party: Prof. Dr. Anselm Kampik, Ludwig-Maximilians-University, Munich
ClinicalTrials.gov Identifier: NCT01208948     History of Changes
Other Study ID Numbers: DMP 77.1.99
Study First Received: September 23, 2010
Last Updated: September 23, 2010
Health Authority: Germany: The trial was conducted in accordance with the Europeandirective 91/50EEC and the International Conference on Harmonization (ICH) consolidated guidelines for Good Clinical Practice (GCP) dated July 17th 1996 which originated from the ethical prin

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Retinopathy
Edema
Macular Edema
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
 Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Thioctic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013