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

Not Applicable

• Conditions: Diabetic Retinopathy
• Interventions: Dietary Supplement: OcuStem Supplementation

• Registration Number: NCT02353923
• Lead Sponsor: Aidan Products LLC

Brief Summary

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

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 Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-10-17
• Study First Submitted QC: 2015-01-29
• Study First Posted: 2015-02-03
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-14
• Last Update Posted: 2015-08-18
• Primary Completion: 2016-05
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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:

  1. Current regular use of insulin for the treatment of diabetes
  2. Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
  3. Documented diabetes by ADA and/or WHO criteria.

• The study eye must meet the following:

  1. Presence of microaneurysms or at least mild non-proliferative diabetic retinopathy (level 20 or higher) on clinical exam.
  2. No presence of center-involved diabetic macular edema (DME) as evidenced by OCT central subfield thickness <250 microns(or spectral domain OCT equivalent).
  3. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OcuStem Supplementation	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.

Primary Outcome Measures

Name	Time	Method
Change in Electronic-ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity testing	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

Secondary Outcome Measures

Name	Time	Method
Change in Optical Coherence Tomography OCT (Optical Coherence Tomography)	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
Change in Microperimetry testing of macular function	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
Change in Blood levels of circulating endothelial progenitor cells (EPC)	0 months, 3 months, 6 months	Blood levels of circulating endothelial progenitor cells (EPC) as determined by CD34 levels
Change in Fluorescein Angiography	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.
Change in Hemoglobin A1C blood levels	0 months, 3 months, 6 months	This is a well-established standard marker for diabetic control