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Observational Study for Diabetic Retinopathy Biomarkers

This observational study aims to find a marker in your blood that can tell us about the health of the blood vessels in the back of your eye (retina) if you have diabetic retinopathy (DR). DR is a complication of diabetes where these blood vessels don't work properly, affecting your vision. Researchers will collect blood samples to study specialized cells and their genetic material (mRNA and miRNA) to identify a marker for DR. You may be able to join if you are 18 or older, have type 2 diabetes, and haven't had certain eye treatments in the past year. The study is looking for 192 participants.

Study design
This is an observational study, meaning researchers will collect information without giving any specific treatment. It plans to enroll 192 participants.
What's involved
You would have blood samples collected via venipuncture at the beginning of the study and again in a follow-up visit between 3 to 5 years later.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a follow-up visit between 3 to 5 years after their initial visit.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05079399

Biomarker of Diabetic Retinopathy

Recruiting
Not specifiedAges 18+Observational
Indiana University
~192 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Blood draw

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
mRNA and miRNA sequencing of circulating angiogenic cells isolated from study participants
Measured over Baseline and change in RNA signature in follow up visit (between 3-5 years)
+3 more outcomes measured

Conditions

Diabetic Retinopathy

Explore related trials

Diabetic Retinopathy

Where it's being run

3 sites across 1 states
Indiana3

Who to contact

Ashay D Bhatwadekar, PhD, RPh
[email protected]
3172785075
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • mRNA and miRNA sequencing of circulating angiogenic cells isolated from study participantsBaseline and change in RNA signature in follow up visit (between 3-5 years)
  • Surface marker expression of inflammatory markers using flow cytometryBaseline
  • miRNA expressionBaseline
  • Epigenetic changes in circulating angiogenic cells with different severities of diabetic retinopathyBaseline