Biomarker of Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

Official title:

Biomarker of Diabetic Retinopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05079399
• Other study ID #: 11656
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: Indiana University
• Contact: Ashay D Bhatwadekar, PhD, RPh
• Phone: 3172785075
• Email: abhatwad[@]iupui.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Other:
• Blood draw
Blood samples will be collected via venipuncture

Locations

Country	Name	City	State
United States	Spring Mill Clinic	Carmel	Indiana
United States	Eskenazi Eye Clinic	Indianapolis	Indiana
United States	Glick Eye Institute	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Surface marker expression of inflammatory markers using flow cytometry		Baseline
Primary	miRNA expression		Baseline
Primary	Epigenetic changes in circulating angiogenic cells with different severities of diabetic retinopathy		Baseline
Secondary	Early Treatment Diabetic Retinopathy Study (ETDRS) clinical scoring in wide-field fundus photography	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)
Secondary	Presence or absence of neovascularization and total area of non-perfusion in fluorescein angiography (FA)		Baseline and follow up visit (between 3-5 years)
Secondary	Change in vessel density in optical coherence tomography angiography (OCT-A)		Baseline and follow up visit (between 3-5 years)
Secondary	Change in retinal thickness in optical coherence tomography angiography (OCT-A)		Baseline and follow up visit (between 3-5 years)