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

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02353923
• Other study ID #: OcuStem-001
• Status: Active, not recruiting
• Phase: N/A
• First received: October 17, 2014
• Last updated: August 14, 2015
• Start date: September 2014
• Est. completion date: September 2016

Study information

• Verified date: August 2015
• Source: Aidan Products LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Dietary Supplement:
• OcuStem Supplementation
2800 mg daily dosage of OcuStem, 2 capsules BID.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aidan Products LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Change in Hemoglobin A1C blood levels	This is a well-established standard marker for diabetic control	0 months, 3 months, 6 months	No
Secondary	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	No