Biomarker of Diabetic Retinopathy

July 22, 2026 updated by: Ashay Bhatwadekar, PhD, RPh, Indiana University
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Amir R Hajrasouliha, MD
  • Phone Number: 3179441154
  • Email: amhajras@iu.edu

Study Locations

  • United States
    • Indiana
      • Carmel, Indiana, United States, 46920
        • Recruiting
        • Spring Mill Clinic
        • Contact:
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Eskenazi Eye Clinic
        • Contact:
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Glick Eye Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

We will recruit type 2 diabetes individuals with different severities of diabetic retinopathy and non-diabetes controls.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy Control
Other: Blood draw
Blood samples will be collected via venipuncture
Diabetes but no retinopathy
Other: Blood draw
Blood samples will be collected via venipuncture
Mild non proliferative diabetic retinopathy
Other: Blood draw
Blood samples will be collected via venipuncture
Moderate non proliferative diabetic retinopathy
Other: Blood draw
Blood samples will be collected via venipuncture
Severe non proliferative diabetic retinopathy
Other: Blood draw
Blood samples will be collected via venipuncture
Proliferative diabetic retinopathy
Other: Blood draw
Blood samples will be collected via venipuncture

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
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
Baseline
miRNA expression
Time Frame: Baseline
Baseline
Epigenetic changes in circulating angiogenic cells with different severities of diabetic retinopathy
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Early Treatment Diabetic Retinopathy Study (ETDRS) clinical scoring in wide-field fundus photography
Time Frame: Baseline and follow up visit (between 3-5 years)
The scoring will be between 10 (no retinopathy) and 85 (advanced proliferative diabetic retinopathy). Higher score means worst outcome
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)
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)
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)
Baseline and follow up visit (between 3-5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11656

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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