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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
2800 mg daily dosage of OcuStem, 2 capsules BID.
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
Time frame: 0 months, 3 months, 6 months
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
Time frame: 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.
Time frame: 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
Time frame: 0 months, 3 months, 6 months
Change in Hemoglobin A1C blood levels
This is a well-established standard marker for diabetic control
Time frame: 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
Time frame: 0 months, 3 months, 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.