Biomarker of Diabetic Retinopathy (NCT05079399) | Clinical Trial Compass
RecruitingNot Applicable
Biomarker of Diabetic Retinopathy
United States192 participantsStarted 2022-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
2
Surface marker expression of inflammatory markers using flow cytometry
Timeframe: Baseline
3
miRNA expression
Timeframe: Baseline
4
Epigenetic changes in circulating angiogenic cells with different severities of diabetic retinopathy