OCT Biomarkers for Diabetic Retinopathy



Status:Recruiting
Conditions:Ocular, Diabetes
Therapuetic Areas:Endocrinology, Ophthalmology
Healthy:No
Age Range:18 - 79
Updated:4/17/2018
Start Date:September 2014
End Date:December 2020
Contact:David Poole, COT
Email:pooleb@ohsu.edu
Phone:503-494-8024

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Functional Optical Coherence Tomography-Derived Biomarkers for Diabetic Retinopathy

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.


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
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Thomas Hwang, MD
Phone: 503-494-8024
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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