Biomarker of Diabetic Retinopathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetic Retinopathy
- Sponsor
- Indiana University
- Enrollment
- 192
- Locations
- 3
- Primary Endpoint
- miRNA expression
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Ashay Bhatwadekar, PhD, RPh
Associate Professor Ophthalmology
Indiana University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
miRNA expression
Time Frame: Baseline
mRNA and miRNA sequencing of circulating angiogenic cells isolated from study participants
Time Frame: Baseline and change in RNA signature in follow up visit (between 3-5 years)
Surface marker expression of inflammatory markers using flow cytometry
Time Frame: Baseline
Epigenetic changes in circulating angiogenic cells with different severities of diabetic retinopathy
Time Frame: Baseline
Secondary Outcomes
- 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))