Biomarker of Diabetic Retinopathy

Indiana University192 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

192

Conditions

Diabetic Retinopathy

Interventions

Blood drawOTHER

Blood samples will be collected via venipuncture

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Spring Mill Clinic

Carmel, Indiana, United States

RECRUITING

Eskenazi Eye Clinic

Indianapolis, Indiana, United States

RECRUITING

Glick Eye Institute

Indianapolis, Indiana, United States

RECRUITING

Outcomes

Primary Outcomes

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

miRNA expression

Time frame: Baseline

Epigenetic changes in circulating angiogenic cells with different severities of diabetic retinopathy

Time frame: Baseline

Secondary Outcomes

Early Treatment Diabetic Retinopathy Study (ETDRS) clinical scoring in wide-field fundus photography

The scoring will be between 10 (no retinopathy) and 85 (advanced proliferative diabetic retinopathy). Higher score means worst outcome

Time frame: Baseline and follow up visit (between 3-5 years)

Presence or absence of neovascularization and total area of non-perfusion in fluorescein angiography (FA)

Time frame: Baseline and follow up visit (between 3-5 years)

Change in vessel density in optical coherence tomography angiography (OCT-A)

Time frame: Baseline and follow up visit (between 3-5 years)

Change in retinal thickness in optical coherence tomography angiography (OCT-A)

Time frame: Baseline and follow up visit (between 3-5 years)

Central Contacts

Ashay D Bhatwadekar, PhD, RPh

CONTACT

3172785075 abhatwad@iupui.edu

Amir R Hajrasouliha, MD

CONTACT

3179441154 amhajras@iu.edu

Data from ClinicalTrials.gov

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