Biomarker of Diabetic Retinopathy

Part of paid clinical trials in Carmel, Indiana.

Sponsor
Indiana University
Study ID
NCT05079399
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blood draw — OTHER
    Blood samples will be collected via venipuncture

Study Details

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.

Key Dates

Start date
Jan 1, 2022
Status verified
Mar 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
192 participants (estimated)

Arms

  • Arm: Healthy Control
  • Arm: Diabetes but no retinopathy
  • Arm: Mild non proliferative diabetic retinopathy
  • Arm: Moderate non proliferative diabetic retinopathy
  • Arm: Severe non proliferative diabetic retinopathy
  • Arm: Proliferative diabetic retinopathy

Primary Outcome Measure

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) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Spring Mill ClinicCarmelIndiana46920
Amir R Hajrasouliha, MD
Eskenazi Eye ClinicIndianapolisIndiana46202
Amir R Hajrasouliha, MD
Glick Eye InstituteIndianapolisIndiana46202
Amir R Hajrasouliha, MD
3179441154

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