OCT 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Number of participants with decreased total retinal blood flow by OCT angiography

Time frame: 1 year

Total retinal blood flow will be measured in uL/min.
Number of participants with capillary dropout and/or new abnormal retinal blood vessel growth by OCT angiography

Time frame: 1 year

Neovascular membrane area will be measured in mm2.
Number of participants with measureable macular edema by OCT imaging

Time frame: 1 year

Retinal thickening area will be measured in mm2.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Functional Optical Coherence Tomography-Derived Biomarkers for Diabetic Retinopathy

Important dates

Study start: 2015
Primary completion: 2020
Study completion: 2026
First posted: Jan 1, 2015
Registry last updated: Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting