Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OcuStem Supplementation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OcuStem Supplementation | Dietary Supplement | 2800 mg daily dosage of OcuStem, 2 capsules BID. |
|
| 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 |
| 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 |
Not provided
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:
The study eye must meet the following:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shalesh Kaushal, MD | Retina Specialty Institute | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |