Recruiting

Observational StudyBiomarker of Diabetic Retinopathy

Sponsor:

Indiana University

Code:

NCT05079399

Conditions

Diabetic Retinopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blood draw

Study Details

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.

Conditions

Diabetic Retinopathy

Study ID

NCT05079399

Start date

Jan 1, 2022

Status verified date

Jun, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

192 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Control

Diabetes but no retinopathy

Mild non proliferative diabetic retinopathy

Moderate non proliferative diabetic retinopathy

Severe non proliferative diabetic retinopathy

Proliferative diabetic retinopathy

Interventions

Blood draw

Blood samples will be collected via venipuncture

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) ]
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 ]

Central Contacts and Locations

Central contacts

Ashay D Bhatwadekar, PhD, RPh

3172785075 abhatwad@iupui.edu

Amir R Hajrasouliha, MD

3179441154 amhajras@iu.edu

Locations

Spring Mill Clinic

Recruiting

Carmel, Indiana, United States, 46920

Contacts

Amir R Hajrasouliha, MD

amhajras@iu.edu

Eskenazi Eye Clinic

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Amir R Hajrasouliha, MD

amhajras@iu.edu

Glick Eye Institute

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Amir R Hajrasouliha, MD

3179441154 amhajras@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Jul 23, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-07-23.