NCT01880372

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

2.6 years

First QC Date

June 13, 2013

Last Update Submit

February 12, 2019

Conditions

Moderate Non-proliferative Diabetic Retinopathy

Keywords

DiabetesDiabetic RetinopathyRetinopathyFree radicalRetinal diseasesAntioxidantsProtective agentsThioctic acid

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Changes in the plasma level of glutathione as measured by ELISA technique

    Serum analysis done at baseline, 6 and 12 month

Other Outcomes (2)

  • 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

Study Arms (2)

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.

Dietary Supplement: Alpha Lipoic Acid

Alpha Lipoic Acid Control Group

NO INTERVENTION

The control group will follow routine care alone.

Interventions

Alpha Lipoic AcidDIETARY_SUPPLEMENT

Same as Arm description

Also known as: ALA
Alpha Lipoic Acid Assignment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ferris State University

Big Rapids, Michigan, 49307, United States

Location

Retina Specialists of Michigan

Grand Rapids, Michigan, 49525, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetic RetinopathyRetinal Diseases

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipids

Study Officials

  • Arinze Nkemdirim Okere, PharmD, MS

    Florida A & M University, College of Pharmacy and Pharmaceutical sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2013

First Posted

June 19, 2013

Study Start

September 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

US(2)