Biomarker of Diabetic Retinopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood draw.
- Who it may be relevant to
- Registry conditions: Diabetic Retinopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Blood draw
Blood samples will be collected via venipuncture
Primary outcome measures
- 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)]
- Surface marker expression of inflammatory markers using flow cytometry [Time frame: Baseline]
- miRNA expression [Time frame: Baseline]
- Epigenetic changes in circulating angiogenic cells with different severities of diabetic retinopathy [Time frame: Baseline]
Secondary outcome measures (4)
- Early Treatment Diabetic Retinopathy Study (ETDRS) clinical scoring in wide-field fundus photography [Time frame: Baseline and follow up visit (between 3-5 years)]
- 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)]
- Change in vessel density in optical coherence tomography angiography (OCT-A) [Time frame: Baseline and follow up visit (between 3-5 years)]
- Change in retinal thickness in optical coherence tomography angiography (OCT-A) [Time frame: Baseline and follow up visit (between 3-5 years)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- Spring Mill Clinic — Carmel
- Eskenazi Eye Clinic — Indianapolis
- Glick Eye Institute — Indianapolis
Identifiers
NCT: NCT05079399 · 11656