The Use of Alpha Lipoic Acid for the Treatment and Prevention of Diabetic Retinopathy



Status:Terminated
Conditions:Ocular, Diabetes
Therapuetic Areas:Endocrinology, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:September 2013
End Date:April 2016

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Pilot Study: The Use of Alpha Lipoic Acid for the Treatment and Prevention of Diabetic Retinopathy

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.

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.

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
We found this trial at
2
sites
Big Rapids, Michigan 49307
Phone: 231-591-2245
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Big Rapids, MI
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Grand Rapids, Michigan
Principal Investigator: Thomas Aaberg, MD
Phone: 616-954-2020
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Grand Rapids, MI
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