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

Ludwig Maximilian University of Munich

Status and phase

Completed

Phase 3

Conditions

Macular Edema

Diabetes Mellitus

Treatments

Drug: 1,2 dithiolane 3 valeric acid

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01208948

DMP 77.1.99

Details and patient eligibility

About

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

Full 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.

Enrollment

520 patients

Sex

All

Ages

45 to 68 years old

Volunteers

No Healthy Volunteers

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