The Use of Alpha Lipoic Acid for the Treatment and Prevention of Diabetic Retinopathy (ALA-TPD)
Primary Purpose
Moderate Non-proliferative Diabetic Retinopathy
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alpha Lipoic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Moderate Non-proliferative Diabetic Retinopathy focused on measuring Diabetes, Diabetic Retinopathy, Retinopathy, Free radical, Retinal diseases, Antioxidants, Protective agents, Thioctic acid
Eligibility Criteria
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
Sites / Locations
- Ferris State University
- Retina Specialists of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Alpha Lipoic Acid Assignment Group
Alpha Lipoic Acid Control Group
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Changes in the plasma level of glutathione as measured by ELISA technique
Full Information
NCT ID
NCT01880372
First Posted
June 13, 2013
Last Updated
February 12, 2019
Sponsor
Ferris State University
Collaborators
Retina Specialists of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT01880372
Brief Title
The Use of Alpha Lipoic Acid for the Treatment and Prevention of Diabetic Retinopathy
Acronym
ALA-TPD
Official Title
Pilot Study: The Use of Alpha Lipoic Acid for the Treatment and Prevention of Diabetic Retinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Low number of patients enrolled
Study Start Date
September 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferris State University
Collaborators
Retina Specialists of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Non-proliferative Diabetic Retinopathy
Keywords
Diabetes, Diabetic Retinopathy, Retinopathy, Free radical, Retinal diseases, Antioxidants, Protective agents, Thioctic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alpha Lipoic Acid Assignment Group
Arm Type
Experimental
Arm Description
Alpha lipoic acid assignment group will follow routine care and receive 600 mg oral administration of lipoic acid daily.
Arm Title
Alpha Lipoic Acid Control Group
Arm Type
No Intervention
Arm Description
The control group will follow routine care alone.
Intervention Type
Dietary Supplement
Intervention Name(s)
Alpha Lipoic Acid
Other Intervention Name(s)
ALA
Intervention Description
Same as Arm description
Primary Outcome Measure Information:
Title
Decreased progression of diabetic retinopathy.
Description
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
Time Frame
Visual examination and serum analysis will be done at baseline, 6 and 12 month
Secondary Outcome Measure Information:
Title
Changes in the plasma level of glutathione as measured by ELISA technique
Time Frame
Serum analysis done at baseline, 6 and 12 month
Other Pre-specified Outcome Measures:
Title
Changes in retinal thickness as measured by optical coherence tomography (OCT)
Time Frame
Procedure done at baseline, 6 and 12 month
Title
Changes in visual acuity as measured by electronic visual testing algorithm
Time Frame
Visual examination done at baseline, 6 and 12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arinze Nkemdirim Okere, PharmD, MS
Organizational Affiliation
Florida A & M University, College of Pharmacy and Pharmaceutical sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ferris State University
City
Big Rapids
State/Province
Michigan
ZIP/Postal Code
49307
Country
United States
Facility Name
Retina Specialists of Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.umm.edu/altmed/articles/alpha-lipoic-000285.htm
Description
Mechanism and clinical uses of alpha lipoic acid
Learn more about this trial
The Use of Alpha Lipoic Acid for the Treatment and Prevention of Diabetic Retinopathy
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