Study Stopped
Low number of patients enrolled
The Use of Alpha Lipoic Acid for the Treatment and Prevention of Diabetic Retinopathy
ALA-TPD
Pilot Study: The Use of Alpha Lipoic Acid for the Treatment and Prevention of Diabetic Retinopathy
Sponsor study identifier
interventional
1
1 country
2
Study Start
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2016
Actual (reported)Study Completion
April 2016
Actual (reported)The purpose of this study is to evaluate the role of alpha lipoic acid in patients who have moderate non-proliferative diabetic retinopathy. The primary aim of this study is to test the hypothesis that the addition of alpha lipoic acid in a diabetic patient's therapeutic regimen can decrease the progression of diabetic retinopathy and preserve visual acuity.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 13, 2013
Actual (reported)June 19, 2013
Actual (reported)September 2013
Date type not reportedThis date has not been verified as actual or estimated.
April 2016
Actual (reported)April 2016
Actual (reported)Decreased progression of diabetic retinopathy.
Decreased progression of diabetic retinopathy as measured and graded by using Standard ETDRS 7 -field color stereoscopic funds photograph, and also by measuring the serum levels of interleukin 6 and 8, VEGF, interferon 2 alpha and M-CSF using ELISA technique
Visual examination and serum analysis will be done at baseline, 6 and 12 month
Changes in the plasma level of glutathione as measured by ELISA technique
Serum analysis done at baseline, 6 and 12 month
Changes in retinal thickness as measured by optical coherence tomography (OCT)
Procedure done at baseline, 6 and 12 month
Changes in visual acuity as measured by electronic visual testing algorithm
Visual examination done at baseline, 6 and 12 month
Alpha lipoic acid assignment group will follow routine care and receive 600 mg oral administration of lipoic acid daily.
The control group will follow routine care alone.
Same as Arm description
Ferris State University
Big Rapids, Michigan, 49307, United States
Retina Specialists of Michigan
Grand Rapids, Michigan, 49525, United States
Arinze Nkemdirim Okere, PharmD, MS
Florida A & M University, College of Pharmacy and Pharmaceutical sciences
1 participants (actual enrollment reported by the registry).
First Submitted
June 13, 2013
First Posted
June 19, 2013
Study Start
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
Lipoic Acid Supplement for Cystine Stone
Contact the study team to confirm eligibility.
Primary Completion
April 2016
Actual (reported)Study Completion
April 2016
Actual (reported)Last Updated
February 15, 2019
Record last verified: 2019-02
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Source: ClinicalTrials.gov.
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