NCT02330042Active, not recruiting
OCT Biomarkers for Diabetic Retinopathy
Functional Optical Coherence Tomography-Derived Biomarkers for Diabetic Retinopathy
Source: ClinicalTrials.gov · Last updated 9 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 165 (actual)
- First submitted
- 30 Dec 2014
- Start date
- 26 Jan 2015
- Primary completion date
- 24 Feb 2020
- Lead sponsor
- Oregon Health and Science University
- Diseases
- Diabetic eye disease
- NCT number
- NCT02330042
What you commit to
- Study type: Observational
- Participants enrolled: 165
- From 26 Jan 2015 to the primary completion date, 24 Feb 2020
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of major eye surgery within 4 months prior to enrollment in this study
- History of major eye surgery within 4 months prior to enrollment in this study
Other illness
- Significant kidney disease, kidney failure or kidney transplant
- Unstable medical status, including blood pressure greater than 180/110 or unstable heart disease
- Presence of an eye disease (other than diabetic retinopathy) that can affect retinal blood flow, retinal permeability or retinal anatomy
- Significant kidney disease, kidney failure or kidney transplant
- Unstable medical status, including blood pressure greater than 180/110 or unstable heart disease
- Presence of any eye disease that can affect retinal blood flow, retinal permeability or retinal anatomy
Other
- Vision worse than 20/200
- Inability to maintain fixation for OCT imaging
- Pregnant or nursing an infant
- Significant cataract, corneal scar, vitreous bleed or other media opacity
- Vision worse than 20/200
- Inability to maintain fixation for OCT imaging
- Pregnant or nursing an infant
- Significant cataract, corneal scar, vitreous bleed or other media opacity
Who the study is looking for
- Male or female participants 18-79 years old
- With Type 1 diabetes for over 5 years or Type 2 diabetes of any duration
- Male or female participants 18-79 years old
Age in the registry: 18 years to 79 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.