OCT Biomarkers for Diabetic Retinopathy
- Conditions
- Diabetic Retinopathy
- Registration Number
- NCT02330042
- Lead Sponsor
- Oregon Health and Science University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 165
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with capillary dropout and/or new abnormal retinal blood vessel growth by OCT angiography 1 year Neovascular membrane area will be measured in mm2.
Number of participants with measureable macular edema by OCT imaging 1 year Retinal thickening area will be measured in mm2.
Number of participants with decreased total retinal blood flow by OCT angiography 1 year Total retinal blood flow will be measured in uL/min.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Oregon Health & Science University
🇺🇸Portland, Oregon, United States