Biomarker of Diabetic Retinopathy

NCT ID: NCT05079399

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Diabetic Retinopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Control

Blood draw

Intervention Type OTHER

Blood samples will be collected via venipuncture

Diabetes but no retinopathy

Blood draw

Intervention Type OTHER

Blood samples will be collected via venipuncture

Mild non proliferative diabetic retinopathy

Blood draw

Intervention Type OTHER

Blood samples will be collected via venipuncture

Moderate non proliferative diabetic retinopathy

Blood draw

Intervention Type OTHER

Blood samples will be collected via venipuncture

Severe non proliferative diabetic retinopathy

Blood draw

Intervention Type OTHER

Blood samples will be collected via venipuncture

Proliferative diabetic retinopathy

Blood draw

Intervention Type OTHER

Blood samples will be collected via venipuncture

Interventions

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Blood draw

Blood samples will be collected via venipuncture

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Ashay Bhatwadekar, PhD, RPh

Associate Professor Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Spring Mill Clinic

Carmel, Indiana, United States

Site Status RECRUITING

Eskenazi Eye Clinic

Indianapolis, Indiana, United States

Site Status RECRUITING

Glick Eye Institute

Indianapolis, Indiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ashay D Bhatwadekar, PhD, RPh

Role: CONTACT

3172785075

Amir R Hajrasouliha, MD

Role: CONTACT

3179441154

Facility Contacts

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Amir R Hajrasouliha, MD

Role: primary

Amir R Hajrasouliha, MD

Role: primary

Amir R Hajrasouliha, MD

Role: primary

3179441154

Other Identifiers

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11656

Identifier Type: -

Identifier Source: org_study_id

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