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

This study has been completed.
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01208948
First received: September 23, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted

September 23, 2010
September 23, 2010
July 2000
April 2005   (final data collection date for primary outcome measure)
occurrence of clinically significant macular edema (CSME) within a follow-up period of 2 years [ Time Frame: two years ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
The time to CSME development [ Time Frame: two years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Clinical Trial on Alpha Lipoic Acid in Diabetic Macular Edema
Alpha Lipoic Acid in the Treatment of Diabetic Retinopathy

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Diabetes Mellitus
  • Macular Edema
Drug: 1,2 dithiolane 3 valeric acid
600 mg alpha lipoic acid per day
  • Active Comparator: Alpha lipoic acid 600 mg
    Intervention: Drug: 1,2 dithiolane 3 valeric acid
  • Placebo Comparator: placebo pill
    Intervention: Drug: 1,2 dithiolane 3 valeric acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
520
December 2005
April 2005   (final data collection date for primary outcome measure)

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
Both
45 Years to 68 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01208948
DMP 77.1.99
Yes
Prof. Dr. Anselm Kampik, Ludwig-Maximilians-University, Munich
Ludwig-Maximilians - University of Munich
Bausch & Lomb Incorporated
Study Director: Michael W Ulbig, MD Ludwig-Maximilians - University of Munich
Ludwig-Maximilians - University of Munich
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP