Biomarker of Diabetic Retinopathy

Recruiting

• Conditions: Diabetic Retinopathy
• Interventions: Other: Blood draw

• Registration Number: NCT05079399
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-11
• Study First Submitted QC: 2021-10-12
• Study First Posted: 2021-10-15
• Study Start: 2022-01-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 192

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe non proliferative diabetic retinopathy	Blood draw	-
Moderate non proliferative diabetic retinopathy	Blood draw	-
Proliferative diabetic retinopathy	Blood draw	-
Healthy Control	Blood draw	-
Mild non proliferative diabetic retinopathy	Blood draw	-
Diabetes but no retinopathy	Blood draw	-

Primary Outcome Measures

Name	Time	Method
miRNA expression	Baseline
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
Epigenetic changes in circulating angiogenic cells with different severities of diabetic retinopathy	Baseline

Secondary Outcome Measures

Name	Time	Method
Change in retinal thickness in optical coherence tomography angiography (OCT-A)	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)
Presence or absence of neovascularization and total area of non-perfusion in fluorescein angiography (FA)	Baseline and follow up visit (between 3-5 years)
Early Treatment Diabetic Retinopathy Study (ETDRS) clinical scoring in wide-field fundus photography	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

Trial Locations

Locations (3)

Spring Mill Clinic; 🇺🇸 Carmel,, Indiana, United States

Eskenazi Eye Clinic; 🇺🇸 Indianapolis, Indiana, United States

Glick Eye Institute; 🇺🇸 Indianapolis, Indiana, United States