Biomarker of Diabetic Retinopathy

NCT05079399 | Recruiting

• 1 other identifier: 11656
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (4)

• mRNA and miRNA sequencing of circulating angiogenic cells isolated from study participants

  Baseline and change in RNA signature in follow up visit (between 3-5 years)

• Surface marker expression of inflammatory markers using flow cytometry

  Baseline

• miRNA expression

  Baseline

• Epigenetic changes in circulating angiogenic cells with different severities of diabetic retinopathy

  Baseline

Secondary Outcomes (4)

• Early Treatment Diabetic Retinopathy Study (ETDRS) clinical scoring in wide-field fundus photography

  Baseline and follow up visit (between 3-5 years)

• Presence or absence of neovascularization and total area of non-perfusion in fluorescein angiography (FA)

  Baseline and follow up visit (between 3-5 years)

• Change in vessel density in optical coherence tomography angiography (OCT-A)

  Baseline and follow up visit (between 3-5 years)

• Change in retinal thickness in optical coherence tomography angiography (OCT-A)

  Baseline and follow up visit (between 3-5 years)

Study Arms (6)

Healthy Control

Other: Blood draw

Diabetes but no retinopathy

Other: Blood draw

Mild non proliferative diabetic retinopathy

Other: Blood draw

Moderate non proliferative diabetic retinopathy

Other: Blood draw

Severe non proliferative diabetic retinopathy

Other: Blood draw

Proliferative diabetic retinopathy

Other: Blood draw

Interventions

Blood draw OTHER

Blood samples will be collected via venipuncture

Diabetes but no retinopathy; Healthy Control; Mild non proliferative diabetic retinopathy; Moderate non proliferative diabetic retinopathy; Proliferative diabetic retinopathy; Severe non proliferative diabetic retinopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (3)

Spring Mill Clinic

Carmel, Indiana, 46920, United States

RECRUITING

Eskenazi Eye Clinic

Indianapolis, Indiana, 46202, United States

RECRUITING

Glick Eye Institute

Indianapolis, Indiana, 46202, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Ribonucleic acid (RNA)

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Ashay D Bhatwadekar, PhD, RPh

CONTACT

3172785075; abhatwad@iupui.edu

Amir R Hajrasouliha, MD

CONTACT

3179441154; amhajras@iu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Ophthalmology

Study Record Dates

• First Submitted: September 11, 2021
• First Posted: October 15, 2021
• Study Start: January 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)