Moderate Non-proliferative Diabetic RetinopathyALA-TPDNCT01880372
The Use of Alpha Lipoic Acid for the Treatment and Prevention of Diabetic Retinopathy
A study testing Alpha Lipoic Acid in people with Moderate Non-proliferative Diabetic Retinopathy, run by Ferris State University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate Non-proliferative Diabetic Retinopathy
- What is being tested?
- Alpha Lipoic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2013to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ferris State University
Big Rapids, Michigan, 49307
Retina Specialists of Michigan
Grand Rapids, Michigan, 49525
About this study
Official title: 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.
Read the 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.
- Being tested
- Alpha Lipoic Acid
- Keywords
- Diabetes, Diabetic Retinopathy, Retinopathy, Free radical, Retinal diseases, Antioxidants, Protective agents, Thioctic acid
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha Lipoic AcidDietary supplement
Also called ALA
Same as Arm description
| Study group | Role | What they receive |
|---|---|---|
| Alpha Lipoic Acid Assignment Group | Experimental | Alpha lipoic acid assignment group will follow routine care and receive 600 mg oral administration of lipoic acid daily. Receives: Dietary Supplement: Alpha Lipoic Acid |
| Alpha Lipoic Acid Control Group | No intervention | The control group will follow routine care alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Visual examination and serum analysis will be done at baseline, 6 and 12 month
Secondary outcomes (1)
Changes in the plasma level of glutathione as measured by ELISA technique
Measured: Serum analysis done at baseline, 6 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: Low number of patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Non-proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferris State University
- Sponsor type
- University, hospital or other
- Collaborators
- Retina Specialists of Michigan
- Responsible party
- Sponsor
- Investigators
- Arinze Nkemdirim Okere, PharmD, MS, Principal investigator, Florida A & M University, College of Pharmacy and Pharmaceutical sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880372
- Sponsor's protocol ID
- FSU130106
- Acronym
- ALA-TPD
- Status last verified
- Feb 2019
- First submitted
- 13 Jun 2013
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: The Use of Alpha Lipoic Acid for the Treatment and Prevention of Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01880372
- Acronym / sponsor ID
- ALA-TPD / FSU130106
- Keywords
- Diabetes, Diabetic Retinopathy, Retinopathy, Free radical, Retinal diseases, Antioxidants, Protective agents, Thioctic acid
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low number of patients enrolled
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Ferris State UniversityUniversity, hospital or other
- Collaborators
- Retina Specialists of Michigan
- Study start
- Sep 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 19 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alpha Lipoic Acid Assignment Group | Experimental | Dietary Supplement: Alpha Lipoic AcidAlpha lipoic acid assignment group will follow routine care and receive 600 mg oral administration of lipoic acid daily. |
| Alpha Lipoic Acid Control Group | No intervention | –The control group will follow routine care alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha Lipoic AcidAlso: ALASame as Arm description | Dietary supplement | Alpha Lipoic Acid Assignment Group |
Primary outcome
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
1 secondary outcome
Changes in the plasma level of glutathione as measured by ELISA technique
Time frame: Serum analysis done at baseline, 6 and 12 month
Results and safety
The study was stopped early (reason given: Low number of patients enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Mechanism and clinical uses of alpha lipoic acidLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arinze Nkemdirim Okere, PharmD, MS principal investigator
Florida A & M University, College of Pharmacy and Pharmaceutical sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha Lipoic Acid in people with Moderate Non-proliferative Diabetic Retinopathy, run by Ferris State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low number of patients enrolled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased progression of diabetic retinopathy. (time frame: Visual examination and serum analysis will be done at baseline, 6 and 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.