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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Control |
| ||
| Diabetes but no retinopathy |
| ||
| Mild non proliferative diabetic retinopathy |
| ||
| Moderate non proliferative diabetic retinopathy |
| ||
| Severe non proliferative diabetic retinopathy |
| ||
| Proliferative diabetic retinopathy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draw | Other | Blood samples will be collected via venipuncture |
|
| Measure | Description | Time Frame |
|---|---|---|
| mRNA and miRNA sequencing of circulating angiogenic cells isolated from study participants | Baseline and change in RNA signature in follow up visit (between 3-5 years) | |
| Surface marker expression of inflammatory markers using flow cytometry | Baseline | |
| miRNA expression | Baseline | |
| Epigenetic changes in circulating angiogenic cells with different severities of diabetic retinopathy | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and follow up visit (between 3-5 years) |
| Presence or absence of neovascularization and total area of non-perfusion in fluorescein angiography (FA) |
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Inclusion Criteria:
Exclusion Criteria:
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We will recruit type 2 diabetes individuals with different severities of diabetic retinopathy and non-diabetes controls.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashay D Bhatwadekar, PhD, RPh | Contact | 3172785075 | abhatwad@iupui.edu | |
| Amir R Hajrasouliha, MD | Contact | 3179441154 | amhajras@iu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spring Mill Clinic | Recruiting | Carmel | Indiana | 46920 | United States |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Ribonucleic acid (RNA)
| Baseline and follow up visit (between 3-5 years) |
| Change in vessel density in optical coherence tomography angiography (OCT-A) | Baseline and follow up visit (between 3-5 years) |
| Change in retinal thickness in optical coherence tomography angiography (OCT-A) | Baseline and follow up visit (between 3-5 years) |
| Eskenazi Eye Clinic | Recruiting | Indianapolis | Indiana | 46202 | United States |
|
| Glick Eye Institute | Recruiting | Indianapolis | Indiana | 46202 | United States |
|
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |