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NCT Number: NCT05079399

Biomarker of Diabetic Retinopathy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Spring Mill Clinic, Carmel, Indiana, United States

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Draw

Other

Blood samples will be collected via venipuncture

Primary outcomes

  1. 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)

  2. Surface marker expression of inflammatory markers using flow cytometry

    Time frame: Baseline

  3. miRNA expression

    Time frame: Baseline

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

    Time frame: Baseline

Secondary outcomes

  1. 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

  2. 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)

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

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

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Amir R Hajrasouliha, MD

CONTACT

[email protected]

3179441154

Ashay D Bhatwadekar, PhD, RPh

CONTACT

[email protected]

3172785075

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Oct 15, 2021
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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