OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Change in Electronic-ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity testing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Current regular use of insulin for the treatment of diabetes
- •Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
- •Documented diabetes by ADA and/or WHO criteria.
- •The study eye must meet the following:
- •Presence of microaneurysms or at least mild non-proliferative diabetic retinopathy (level 20 or higher) on clinical exam.
- •No presence of center-involved diabetic macular edema (DME) as evidenced by OCT central subfield thickness <250 microns(or spectral domain OCT equivalent).
- •Visual acuity light perception or better.
排除标准
- •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
结局指标
主要结局
Change in Electronic-ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity testing
时间窗: 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
次要结局
- Change in Optical Coherence Tomography OCT (Optical Coherence Tomography)(0 months, 3 months, 6 months)
- Change in Microperimetry testing of macular function(0 months, 3 months, 6 months)
- Change in Blood levels of circulating endothelial progenitor cells (EPC)(0 months, 3 months, 6 months)
- Change in Fluorescein Angiography(0 months, 3 months, 6 months)
- Change in Hemoglobin A1C blood levels(0 months, 3 months, 6 months)