- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02353923
OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy
August 14, 2015 updated by: Aidan Products LLC
The purpose of this study is to determine whether supplementation with OcuStem, a nutritional supplement, will reduce the progression of mild to moderate diabetic retinopathy.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This research study is designed to evaluate the effects of a nutritional supplement, OcuStem, on mild to moderate nonproliferative diabetic retinopathy.
In this condition blood vessels in the back of the eye, an area termed the retina, are deteriorating.
OcuStem contains ingredients that have previously been demonstrated in clinical trials to stimulate a type of cell, called "endothelial progenitor cells" to increase in circulation.
Animal studies have shown that increasing endothelial progenitor cell numbers inhibits progression of diabetic retinopathy.
The hypothesis of the study is that a 6 month course of OcuStem will reduce progression of mild to moderate diabetic retinopathy.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥ 18 years
- One or both study eyes per subject may be enrolled.
- Diagnosis of diabetes mellitus (type 1 or type 2)
Any one of the following will be considered to be sufficient evidence that diabetes is present:
- Current regular use of insulin for the treatment of diabetes
- Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
- Documented diabetes by ADA and/or WHO criteria.
The study eye must meet the following:
- Presence of microaneurysms or at least mild non-proliferative diabetic retinopathy (level 20 or higher) on clinical exam.
- No presence of center-involved diabetic macular edema (DME) as evidenced by OCT central subfield thickness <250 microns(or spectral domain OCT equivalent).
- Visual acuity light perception or better.
Exclusion Criteria:
- A current ocular condition that, in the opinion of the investigator, visual acuity might be affected now and/or may need to be treated (e.g., DME, foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition (cataract ), epiretinal membrane or vitro-macular traction) or during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.).
- A history of a major ocular surgery (including vitrectomy, scleral buckle, any intraocular surgery, etc.) within prior 4 months or major ocular surgery including cataract removal anticipated within the next 4 months following enrollment.
- Pregnant Women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OcuStem Supplementation
Twice daily supplementation with OcuStem.
Subjects will take 2 capsules in the morning and 2 capsules at night for a total of 2800 mg/day of active ingredients.
|
2800 mg daily dosage of OcuStem, 2 capsules BID.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Electronic-ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity testing
Time Frame: 0 months, 3 months, 6 months
|
Electronic-ETDRS visual acuity testing at 3 meters using the Electronic Visual Acuity Tester (including protocol refraction) in each eye
|
0 months, 3 months, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Optical Coherence Tomography OCT (Optical Coherence Tomography)
Time Frame: 0 months, 3 months, 6 months
|
Optical Coherence Tomography OCT on the study eye or eyes.
This is to determine if there is any development of diabetic macular edema
|
0 months, 3 months, 6 months
|
Change in Fluorescein Angiography
Time Frame: 0 months, 3 months, 6 months
|
Fluorescein Angiography on the study eye or eyes.
This is to determine if there is any subtle evidence of diabetic changes including microaneurisms or mild macular edema.
|
0 months, 3 months, 6 months
|
Change in Microperimetry testing of macular function
Time Frame: 0 months, 3 months, 6 months
|
Microperimetry testing of macular function.
This non-invasive test measures retinal sensitivity to various intensities of light in a defined region of the macula
|
0 months, 3 months, 6 months
|
Change in Hemoglobin A1C blood levels
Time Frame: 0 months, 3 months, 6 months
|
This is a well-established standard marker for diabetic control
|
0 months, 3 months, 6 months
|
Change in Blood levels of circulating endothelial progenitor cells (EPC)
Time Frame: 0 months, 3 months, 6 months
|
Blood levels of circulating endothelial progenitor cells (EPC) as determined by CD34 levels
|
0 months, 3 months, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shalesh Kaushal, MD, Retina Specialty Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Anticipated)
May 1, 2016
Study Completion (Anticipated)
September 1, 2016
Study Registration Dates
First Submitted
October 17, 2014
First Submitted That Met QC Criteria
January 29, 2015
First Posted (Estimate)
February 3, 2015
Study Record Updates
Last Update Posted (Estimate)
August 18, 2015
Last Update Submitted That Met QC Criteria
August 14, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OcuStem-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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