OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy

Conditions
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Diabetic Retinopathy

Intervention / Treatment
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* Dietary Supplement: OcuStem Supplementation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OcuStem Supplementation<br>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. | Dietary Supplement: OcuStem Supplementation<br>* 2800 mg daily dosage of OcuStem, 2 capsules BID.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Electronic-ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity testing | 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) | 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 | 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 | 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 | 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) | Blood levels of circulating endothelial progenitor cells (EPC) as determined by CD34 levels | 0 months, 3 months, 6 months |