This trial is active, not recruiting.

Condition diabetic retinopathy
Treatment ocustem supplementation
Sponsor Aidan Products LLC
Start date September 2014
End date May 2016
Trial size 30 participants
Trial identifier NCT02353923, OcuStem-001


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.
ocustem supplementation
2800 mg daily dosage of OcuStem, 2 capsules BID.

Primary Outcomes

Change in Electronic-ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity testing
time frame: 0 months, 3 months, 6 months

Secondary Outcomes

Change in Optical Coherence Tomography OCT (Optical Coherence Tomography)
time frame: 0 months, 3 months, 6 months
Change in Fluorescein Angiography
time frame: 0 months, 3 months, 6 months
Change in Microperimetry testing of macular function
time frame: 0 months, 3 months, 6 months
Change in Hemoglobin A1C blood levels
time frame: 0 months, 3 months, 6 months
Change in Blood levels of circulating endothelial progenitor cells (EPC)
time frame: 0 months, 3 months, 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy
Principal investigator Shalesh Kaushal, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Aidan Products LLC.