OCT Biomarkers for Diabetic Retinopathy

Study Overview
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Brief Summary
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Diabetic retinopathy (DR) is caused by changes in the blood vessels of the retina associated with long-term Type 1 or Type 2 diabetes mellitus. DR is a leading cause of blindness in the United States. Standard optical coherence tomography (OCT) cannot directly detect vascular changes, which may occur early affecting the passage of blood through the tiny capillaries (reduced capillary flow) or cause the greatest damage through formation of abnormal blood vessel growth (neovascularization). Currently, fluorescein angiography (FA) is the gold standard for detecting these changes, but FA requires an injection of a dye into the vein of the arm of the patient. This dye can cause undesirable side effects. Recently, OCT has been used to make functional measurements (such as total retinal blood flow among others) and to perform angiography. Thus, functional OCT may provide a useful, alternate way to evaluate diabetic retinopathy.

Official Title
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Functional Optical Coherence Tomography-Derived Biomarkers for Diabetic Retinopathy

Conditions
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Diabetic Retinopathy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for participants with diabetes: Male or female participants 18-79 years old With Type 1 diabetes for over 5 years or Type 2 diabetes of any duration Exclusion Criteria for participants with diabetes: Vision worse than 20/200 Inability to maintain fixation for OCT imaging Significant kidney disease, kidney failure or kidney transplant Unstable medical status, including blood pressure greater than 180/110 or unstable heart disease Pregnant or nursing an infant Presence of an eye disease (other than diabetic retinopathy) that can affect retinal blood flow, retinal permeability or retinal anatomy Significant cataract, corneal scar, vitreous bleed or other media opacity History of major eye surgery within 4 months prior to enrollment in this study Inclusion Criteria for participants without diabetes (controls): Male or female participants 18-79 years old Exclusion Criteria for participants without diabetes (controls): Vision worse than 20/200 Inability to maintain fixation for OCT imaging Significant kidney disease, kidney failure or kidney transplant Unstable medical status, including blood pressure greater than 180/110 or unstable heart disease Pregnant or nursing an infant Presence of any eye disease that can affect retinal blood flow, retinal permeability or retinal anatomy Significant cataract, corneal scar, vitreous bleed or other media opacity History of major eye surgery within 4 months prior to enrollment in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Patients with: Type 1 or Type 2 diabetes mellitus severe non-proliferative diabetic retinopathy (NPDR) or proliferative diabetic retinopathy (PDR). | |
| Group B<br>Patients with: Type 1 or Type 2 diabetes mellitus with or without mild to moderate NPDR | |
| Group C (controls)<br>Patients without diabetes or evidence of any form of eye disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with decreased total retinal blood flow by OCT angiography | Total retinal blood flow will be measured in uL/min. | 1 year | 
| Number of participants with capillary dropout and/or new abnormal retinal blood vessel growth by OCT angiography | Neovascular membrane area will be measured in mm2. | 1 year | 
| Number of participants with measureable macular edema by OCT imaging | Retinal thickening area will be measured in mm2. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, OCT, Angiography, Diabetic retinopathy