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Clinical Trial on Alpha Lipoic Acid in Diabetic Macular Edema

NCT ID: NCT01208948

Last Updated: 2010-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Study Completion Date

2005-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Alpha lipoic acid 600 mg

Group Type ACTIVE_COMPARATOR

1,2 dithiolane 3 valeric acid

Intervention Type DRUG

600 mg alpha lipoic acid per day

placebo pill

Group Type PLACEBO_COMPARATOR

1,2 dithiolane 3 valeric acid

Intervention Type DRUG

600 mg alpha lipoic acid per day

Interventions

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1,2 dithiolane 3 valeric acid

600 mg alpha lipoic acid per day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diabetes type II, mild non proliferative diabetic retinopathy,
* Microalbuminuria \> 30 mg/L

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)
* 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
Minimum Eligible Age

45 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Ludwig-Maximilians-University, Munich

Principal Investigators

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Michael W Ulbig, MD

Role: STUDY_DIRECTOR

Ludwig-Maximilians - University of Munich

Locations

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Department of Ophthalmology

Munich, Germany, Germany

Site Status

Countries

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Germany

Other Identifiers

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DMP 77.1.99

Identifier Type: -

Identifier Source: org_study_id