Diabetic RetinopathyNCT02330042
OCT Biomarkers for Diabetic Retinopathy
An observational study of Diabetic Retinopathy, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2015to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with Type 1 diabetes of greater than 5 years duration OR Type 2 diabetes of any duration. Healthy controls are also being enrolled in this study.
Who may be able to join
- Male or female participants 18-79 years old
- With Type 1 diabetes for over 5 years or Type 2 diabetes of any duration
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: 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.
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetes, OCT, Angiography, Diabetic retinopathy
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients with: * Type 1 or Type 2 diabetes mellitus * severe non-proliferative diabetic retinopathy (NPDR) or proliferative diabetic retinopathy (PDR). | |
| Group B | Patients with: * Type 1 or Type 2 diabetes mellitus * with or without mild to moderate NPDR | |
| Group C (controls) | Patients without diabetes or evidence of any form of eye disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with decreased total retinal blood flow by OCT angiography
Total retinal blood flow will be measured in uL/min.
Measured: 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.
Measured: 1 year
Number of participants with measureable macular edema by OCT imaging
Retinal thickening area will be measured in mm2.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study start26 Jan 2015
- Primary completion24 Feb 2020
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Huang, Oregon Health and Science University
- Investigators
- Thomas Hwang, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330042
- Sponsor's protocol ID
- IRB#00010949
- Status last verified
- Sep 2025
- First submitted
- 30 Dec 2014
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Optical Coherence Tomography-Derived Biomarkers for Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT02330042
- Acronym / sponsor ID
- IRB#00010949
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetes, OCT, Angiography, Diabetic retinopathy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 26 Jan 2015 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Patients with: * Type 1 or Type 2 diabetes mellitus * severe non-proliferative diabetic retinopathy (NPDR) or proliferative diabetic retinopathy (PDR). |
| Group B | – | –Patients with: * Type 1 or Type 2 diabetes mellitus * with or without mild to moderate NPDR |
| Group C (controls) | – | –Patients without diabetes or evidence of any form of eye disease |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with Type 1 diabetes of greater than 5 years duration OR Type 2 diabetes of any duration. Healthy controls are also being enrolled in this study.
Key inclusion criteria (2 listed)
- Male or female participants 18-79 years old
- With Type 1 diabetes for over 5 years or Type 2 diabetes of any duration
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Hwang, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with decreased total retinal blood flow by OCT angiography (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.