Clinical Trial on Alpha Lipoic Acid in Diabetic Macular Edema

Overview

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

Full Title of Study: “Alpha Lipoic Acid in the Treatment of Diabetic Retinopathy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2005

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

  • Drug: 1,2 dithiolane 3 valeric acid
    • 600 mg alpha lipoic acid per day

Arms, Groups and Cohorts

  • Active Comparator: Alpha lipoic acid 600 mg
  • Placebo Comparator: placebo pill

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • The time to CSME development
    • Time Frame: two years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: 68 Years

Investigator Details

  • Lead Sponsor
    • Ludwig-Maximilians – University of Munich
  • Collaborator
    • Bausch & Lomb Incorporated
  • Provider of Information About this Clinical Study
    • Prof. Dr. Anselm Kampik, Ludwig-Maximilians-University, Munich
  • Overall Official(s)
    • Michael W Ulbig, MD, Study Director, Ludwig-Maximilians – University of Munich

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