Status:
COMPLETED
Clinical Trial on Alpha Lipoic Acid in Diabetic Macular Edema
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Collaborating Sponsors:
Bausch & Lomb Incorporated
Conditions:
Diabetes Mellitus
Macular Edema
Eligibility:
All Genders
45-68 years
Phase:
PHASE3
Brief Summary
To evaluate the effect of alpha lipoic acid (ALA) on the occurrence of diabetic macular edema.
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 ...
Eligibility Criteria
Inclusion
- Diabetes type II, mild non proliferative diabetic retinopathy,
- Microalbuminuria \> 30 mg/L
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT01208948
Start Date
July 1 2000
End Date
December 1 2005
Last Update
September 24 2010
Active Locations (1)
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1
Department of Ophthalmology
Munich, Germany, Germany, 80336