Health TrialsbyHealthPanel

Biomarker of Diabetic Retinopathy

ConditionDiabetic Retinopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIndiana University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Previous or current malignancy

Acute or chronic infection (HIV, hepatitis B or C, tuberculosis)

Cerebral vascular accident or cerebral vascular procedure

Current pregnancy

Trial population

We will recruit type 2 diabetes individuals with different severities of diabetic retinopathy and non-diabetes controls.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood draw

    Other intervention

    Blood samples will be collected via venipuncture

Treatment groups

192 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Healthy Control1 intervention
Group B: Diabetes but no retinopathy1 intervention
Group C: Mild non proliferative diabetic retinopathy1 intervention
Group D: Moderate non proliferative diabetic retinopathy1 intervention
Group E: Severe non proliferative diabetic retinopathy1 intervention
Group F: Proliferative diabetic retinopathy1 intervention

Trial outcomes

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

The scoring will be between 10 (no retinopathy) and 85 (advanced proliferative diabetic retinopathy). Higher score means worst outcome

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Source ClinicalTrials.gov
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