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

Primary Purpose

Diabetes Mellitus, Macular Edema

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
1,2 dithiolane 3 valeric acid
Sponsored by
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus focused on measuring macular edema, diabetes mellitus, prevention alpha lipoic acid

Eligibility Criteria

45 Years - 68 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Alpha lipoic acid 600 mg

placebo pill

Arm Description

Outcomes

Primary Outcome Measures

occurrence of clinically significant macular edema (CSME) within a follow-up period of 2 years

Secondary Outcome Measures

The time to CSME development

Full Information

First Posted
September 23, 2010
Last Updated
September 23, 2010
Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01208948
Brief Title
Clinical Trial on Alpha Lipoic Acid in Diabetic Macular Edema
Acronym
RETIPON
Official Title
Alpha Lipoic Acid in the Treatment of Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Macular Edema
Keywords
macular edema, diabetes mellitus, prevention alpha lipoic acid

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
520 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alpha lipoic acid 600 mg
Arm Type
Active Comparator
Arm Title
placebo pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
1,2 dithiolane 3 valeric acid
Intervention Description
600 mg alpha lipoic acid per day
Primary Outcome Measure Information:
Title
occurrence of clinically significant macular edema (CSME) within a follow-up period of 2 years
Time Frame
two years
Secondary Outcome Measure Information:
Title
The time to CSME development
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
68 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael W Ulbig, MD
Organizational Affiliation
Ludwig-Maximilians - University of Munich
Official's Role
Study Director
Facility Information:
Facility Name
Department of Ophthalmology
City
Munich
ZIP/Postal Code
80336
Country
Germany

12. IPD Sharing Statement

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Clinical Trial on Alpha Lipoic Acid in Diabetic Macular Edema

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