Biomarker of Diabetic Retinopathy

March 4, 2024 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

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 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:
          • Amir R Hajrasouliha, MD
          • Phone Number: 317-944-1154
          • Email: amhajras@iu.edu

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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
Intervention / Treatment
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

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

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

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)

January 1, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

September 11, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (Actual)

October 15, 2021

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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

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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