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The Use of Alpha Lipoic Acid for the Treatment and Prevention of Diabetic Retinopathy (ALA-TPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01880372
Recruitment Status : Terminated (Low number of patients enrolled)
First Posted : June 19, 2013
Last Update Posted : February 15, 2019
Retina Specialists of Michigan
Information provided by (Responsible Party):
Ferris State University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Moderate Non-proliferative Diabetic Retinopathy Dietary Supplement: Alpha Lipoic Acid Not Applicable

Detailed Description:

Increased production of free radicals and depletion of antioxidants are commonly observed in diabetic patients. Based on animal studies, increased production of free radicals tends to persist even after blood glucose is tightly controlled. The rationale of using a potent antioxidant is based on the observation that increased oxidative stress associated with hyperglycemia can contribute to cellular injury leading to apoptosis; consequently, leading to diabetic retinopathy. Evidence from animal model showed that alpha lipoic acid (a potent antioxidant) was effective for decreasing the progression of diabetic retinopathy and in reducing free radicals.

Therefore, we hypothesize that therapy that can exert a powerful antioxidant activity can provide a therapeutic modality needed to target the pathogenesis of diabetic retinopathy.

This study will be a 12-month pilot study demonstrating the role of alpha lipoic acid in patients who have moderate non-proliferative diabetic retinopathy.

Eligible patients will be randomized to two groups, treatment and control groups. Patients in the treatment group will receive 600 mg of alpha lipoic acid daily with routine care while patient in control group will only follow routine care. Optical coherence tomography (OCT)and electronic visual acuity testing algorithm (ETDRS) will be used to measure changes in retinal thickness and visual acuity respectively. Blood changes in macrophage colony stimulating factor (M-CSF), vascular endothelia growth factor (VEGF), Interferon 2 alpha, interleukin 6 and 8 will also be evaluated and compared between the two groups. Descriptive statistics and intention to treat analysis will be used to compare treatment and control groups.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study: The Use of Alpha Lipoic Acid for the Treatment and Prevention of Diabetic Retinopathy
Study Start Date : September 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Alpha Lipoic Acid Assignment Group
Alpha lipoic acid assignment group will follow routine care and receive 600 mg oral administration of lipoic acid daily.
Dietary Supplement: Alpha Lipoic Acid
Same as Arm description
Other Name: ALA

No Intervention: Alpha Lipoic Acid Control Group
The control group will follow routine care alone.

Primary Outcome Measures :
  1. Decreased progression of diabetic retinopathy. [ Time Frame: Visual examination and serum analysis will be done at baseline, 6 and 12 month ]
    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

Secondary Outcome Measures :
  1. Changes in the plasma level of glutathione as measured by ELISA technique [ Time Frame: Serum analysis done at baseline, 6 and 12 month ]

Other Outcome Measures:
  1. Changes in retinal thickness as measured by optical coherence tomography (OCT) [ Time Frame: Procedure done at baseline, 6 and 12 month ]
  2. Changes in visual acuity as measured by electronic visual testing algorithm [ Time Frame: Visual examination done at baseline, 6 and 12 month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Individual with diabetes mellitus type I or type II mild to moderate non-proliferative diabetic retinopathy which will be based on ETDRS grading scale
  • Patient must be 18 years and older

Exclusion Criteria:

  • Patients with severe non-proliferative or proliferative diabetic retinopathy
  • Patients with macular edema
  • Eye diseases that may interfere with visualization of the fundus such as preretinal hemorrhage, cataract, vitreous hemorrhage
  • Patient that has undergone any type of interventional therapy for diabetic retinopathy (Such as laser photocoagulation, vitrectomy)
  • Amblyopia
  • Glaucoma
  • Patient with cataract surgery within a period of 4 months
  • Patients with other retinal diseases
  • Patients on chronic administration of alpha lipoic acid
  • Known intolerance/hypersensitivity to alpha lipoic acid
  • Patient with history of dialysis in cases of renal insufficiency and history of kidney transplantation
  • Malignancies or life threatening diseases as determined by the investigators
  • Current history of drug or alcohol abuse
  • Pregnant and breast feeding women
  • Cognitively impaired patients
  • Participation in a clinical trial within the last 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01880372

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United States, Michigan
Ferris State University
Big Rapids, Michigan, United States, 49307
Retina Specialists of Michigan
Grand Rapids, Michigan, United States, 49525
Sponsors and Collaborators
Ferris State University
Retina Specialists of Michigan
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Principal Investigator: Arinze Nkemdirim Okere, PharmD, MS Florida A & M University, College of Pharmacy and Pharmaceutical sciences

Additional Information:
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Responsible Party: Ferris State University Identifier: NCT01880372     History of Changes
Other Study ID Numbers: FSU130106
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Keywords provided by Ferris State University:
Diabetic Retinopathy
Free radical
Retinal diseases
Protective agents
Thioctic acid
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Thioctic Acid
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Growth Substances