Clinical trial NCT05079399: Biomarker of Diabetic Retinopathy
Official title: Biomarker of Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Retinopathy
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We will recruit type 2 diabetes individuals with different severities of diabetic retinopathy and non-diabetes controls.

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.


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.

Primary outcomes:
measure: mRNA and miRNA sequencing of circulating angiogenic cells isolated from study participants
timeFrame: Baseline and change in RNA signature in follow up visit (between 3-5 years)
measure: Surface marker expression of inflammatory markers using flow cytometry
timeFrame: Baseline
measure: miRNA expression
timeFrame: Baseline
measure: Epigenetic changes in circulating angiogenic cells with different severities of diabetic retinopathy
timeFrame: Baseline
Secondary outcomes:
measure: Early Treatment Diabetic Retinopathy Study (ETDRS) clinical scoring in wide-field fundus photography
timeFrame: Baseline and follow up visit (between 3-5 years)
measure: Presence or absence of neovascularization and total area of non-perfusion in fluorescein angiography (FA)
timeFrame: Baseline and follow up visit (between 3-5 years)
measure: Change in vessel density in optical coherence tomography angiography (OCT-A)
timeFrame: Baseline and follow up visit (between 3-5 years)
measure: Change in retinal thickness in optical coherence tomography angiography (OCT-A)
timeFrame: Baseline and follow up visit (between 3-5 years)
Other outcomes:
Locations:
city: Carmel,
country: United States
facility: Spring Mill Clinic
state: Indiana
city: Indianapolis
country: United States
facility: Eskenazi Eye Clinic
state: Indiana
city: Indianapolis
country: United States
facility: Glick Eye Institute
state: Indiana
Study officials:
References: