Biomarker of Diabetic Retinopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 6
- 主要终点
- miRNA expression
研究概览
简要总结
Diabetic retinopathy (DR) is a complication of diabetes in which blood vessels supplying blood to the back of the eye (retina) are dysfunctional. This can lead to an improper supply of oxygen and nutrients to the retinal tissue, or it may trigger the formation of new blood vessels in response to the oxygen/nutrient deficiency. Ultimately affecting the normal vision. There is no known marker that will provide information on the health status of retinal blood vessels. Using highly specialized cells in the blood, this study will try to discover a marker of DR.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Ability to cooperate with imaging procedures.
- •Health status: established type 2 diabetes
- •No history of panretinal photocoagulation (PRP)
- •No history of treatment with intravitreal agents for past 12 months
排除标准
- •Previous or current malignancy
- •Acute or chronic infection (HIV, hepatitis B or C, tuberculosis)
- •Cerebral vascular accident or cerebral vascular procedure
- •Current pregnancy
- •History of organ transplantation
- •Presence of a graft (to avoid any effect of the graft)
- •History of previous vitrectomy
- •Subjects with a history of age-related macular degeneration age-related macular degeneration (AMD), glaucoma, uveitis, and branched or central vein occlusion.
研究组 & 干预措施
Severe non proliferative diabetic retinopathy
干预措施: Blood draw (Other)
Proliferative diabetic retinopathy
干预措施: Blood draw (Other)
Diabetes but no retinopathy
干预措施: Blood draw (Other)
Mild non proliferative diabetic retinopathy
干预措施: Blood draw (Other)
Healthy Control
干预措施: Blood draw (Other)
Moderate non proliferative diabetic retinopathy
干预措施: Blood draw (Other)
结局指标
主要结局
miRNA expression
时间窗: Baseline
mRNA and miRNA sequencing of circulating angiogenic cells isolated from study participants
时间窗: Baseline and change in RNA signature in follow up visit (between 3-5 years)
Surface marker expression of inflammatory markers using flow cytometry
时间窗: Baseline
Epigenetic changes in circulating angiogenic cells with different severities of diabetic retinopathy
时间窗: Baseline
次要结局
- Change in retinal thickness in optical coherence tomography angiography (OCT-A)(Baseline and follow up visit (between 3-5 years))
- Change in vessel density in optical coherence tomography angiography (OCT-A)(Baseline and follow up visit (between 3-5 years))
- Presence or absence of neovascularization and total area of non-perfusion in fluorescein angiography (FA)(Baseline and follow up visit (between 3-5 years))
- Early Treatment Diabetic Retinopathy Study (ETDRS) clinical scoring in wide-field fundus photography(Baseline and follow up visit (between 3-5 years))
研究者
Ashay Bhatwadekar, PhD, RPh
Associate Professor Ophthalmology
Indiana University