Diabetic RetinopathyNCT03922932
WF and PR OCTA in 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 a leading cause of vision loss in working-age Americans. Capillary damage from hyperglycemia causes vision loss through downstream effects, such as retinal ischemia, edema, and neovascularization (NV). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy
- How many people
- 290 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2017to Dec 2027
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults age 18 or older with either healthy eyes or diabetic retinopathy
Participant-Related Inclusion Criteria:
- All Diabetics (Groups A, B, C)
- Type 1 diabetes of at least 5 years duration or
- Type 2 diabetes of any duration II. Group B
- Able to return for follow-up over 3 years
Participant-Related Exclusion Criteria:
- Group B
- Significant medical condition that would make long-term follow-up difficult II. Controls (Group D)
- Any medical problems associated with retinal vascular abnormalities (i.e., hypertension, systemic vasculitis, carotid insufficiency, etc.)
Eye-Related Inclusion Criteria:
- Group A:
- Presence of active neovascularization, with or without prior treatment
- Presence of involuted fibrovascular proliferans
II. Group B:
- NPDR of any severity as defined by the International Clinical Diabetic Retinopathy Severity Scale
III. Groups C \& D:
- No evidence of diabetic retinopathy
IV. Group ME:
- Presence of center-involving macular edema requiring treatment
Eye-Related Exclusion Criteria: (Applies to study eye only. May be present in non-study eye.)
- Visual acuity worse than 20/200
- Inability to maintain stable fixation for OCT imaging
- History of major eye surgery (vitrectomy, cataract surgery, scleral buckle, other intraocular surgery, etc.) within 90 days of enrollment
- History of another eye disease or condition that may alter retinal perfusion, permeability, or retinal anatomy
- Substantial media opacity (cataract, corneal scar, vitreous hemorrhage) that may interfere with study imaging
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Wide-Field and Projection-Resolved Optical Coherence Tomography Angiography in Diabetic Retinopathy
Diabetic retinopathy (DR) is a leading cause of vision loss in working-age Americans. Capillary damage from hyperglycemia causes vision loss through downstream effects, such as retinal ischemia, edema, and neovascularization (NV). Proper screening and timely treatment with laser photocoagulation and anti-vascular endothelial growth factor (VEGF) injections can minimize morbidity. In the last decade, clinicians have been able to use objective structural data from optical coherence tomography (OCT) to guide the treatment of diabetic macular edema. Other aspects of care, however, still largely depend on subjective interpretation of clinical features and fluorescein angiography (FA) to determine the disease severity and treatment threshold. The recently developed OCT angiography (OCTA) provides dye-less, injection-free, three-dimensional images of the retinal and choroidal circulation with high capillary contrast. Not only is it safer, faster, and less expensive than conventional dye-based angiography, OCTA provides the potential of giving clinicians objective tools for determining severity of disease by detecting and quantifying NV and non-perfusion.
- 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: PDR | This group will consist of 30 subjects with active proliferative diabetic retinopathy (PDR) and 30 subjects with treated PDR. | |
| Group B: NPDR | This group will consist of 60 subjects with severe non-proliferative diabetic retinopathy (NPDR), 60 subjects with moderate NPDR, and 60 subjects with mild NPDR. | |
| Group ME: Macular Edema | This group is a sub-set of 25 subjects from either Group A or B who have macular edema requiring treatment. | |
| Group C: DM without Retinopathy | This group will consist of 60 subjects with diabetes mellitus (DM) who do not have retinopathy. | |
| Group D: Healthy Controls | This group will consist of 50 subjects with healthy eyes who do not have diabetes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PR-OCTA Measure of Non-Perfusion Areas
Non-perfusion areas of the 3 retinal plexuses and choriocapillaris will be measured in mm2.
Measured: 3 years
Non-PR-OCTA Measure of Retinal Non-Perfusion Areas
Non-perfusion areas of the 3 retinal plexuses will be measured in mm2.
Measured: 1 year
Non-PR-OCTA Retinal Neovascularization Areas
Retinal neovascularization areas will be measured in mm2.
Measured: 1 year
Structural OCT Cyst Volume
Cyst volume will be measured in mm3.
Measured: 1 year
Structural OCT Retinal Thickening Area
The area of retinal thickening 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 posted22 Apr 2019
- Study start30 Aug 2017
- Primary completionJun 2026 (estimated)
- Study completionDec 2027 (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
- 290 participants (estimated)
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
- NCT03922932
- Sponsor's protocol ID
- OHSU IRB#00016932
- Status last verified
- Sep 2025
- First submitted
- 18 Apr 2019
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Wide-Field and Projection-Resolved Optical Coherence Tomography Angiography in Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT03922932
- Acronym / sponsor ID
- OHSU IRB#00016932
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetes, OCT, Angiography, Diabetic retinopathy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Apr 2019 (actual)
- 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 a leading cause of vision loss in working-age Americans. Capillary damage from hyperglycemia causes vision loss through downstream effects, such as retinal ischemia, edema, and neovascularization (NV). Proper screening and timely treatment with laser photocoagulation and anti-vascular endothelial growth factor (VEGF) injections can minimize morbidity. In the last decade, clinicians have been able to use objective structural data from optical coherence tomography (OCT) to guide the treatment of diabetic macular edema. Other aspects of care, however, still largely depend on subjective interpretation of clinical features and fluorescein angiography (FA) to determine the disease severity and treatment threshold. The recently developed OCT angiography (OCTA) provides dye-less, injection-free, three-dimensional images of the retinal and choroidal circulation with high capillary contrast. Not only is it safer, faster, and less expensive than conventional dye-based angiography, OCTA provides the potential of giving clinicians objective tools for determining severity of disease by detecting and quantifying NV and non-perfusion.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A: PDR | – | –This group will consist of 30 subjects with active proliferative diabetic retinopathy (PDR) and 30 subjects with treated PDR. |
| Group B: NPDR | – | –This group will consist of 60 subjects with severe non-proliferative diabetic retinopathy (NPDR), 60 subjects with moderate NPDR, and 60 subjects with mild NPDR. |
| Group ME: Macular Edema | – | –This group is a sub-set of 25 subjects from either Group A or B who have macular edema requiring treatment. |
| Group C: DM without Retinopathy | – | –This group will consist of 60 subjects with diabetes mellitus (DM) who do not have retinopathy. |
| Group D: Healthy Controls | – | –This group will consist of 50 subjects with healthy eyes who do not have diabetes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults age 18 or older with either healthy eyes or diabetic retinopathy
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
PR-OCTA Measure of Non-Perfusion Areas
Time frame: 3 years
Non-perfusion areas of the 3 retinal plexuses and choriocapillaris will be measured in mm2.
Non-PR-OCTA Measure of Retinal Non-Perfusion Areas
Time frame: 1 year
Non-perfusion areas of the 3 retinal plexuses will be measured in mm2.
Non-PR-OCTA Retinal Neovascularization Areas
Time frame: 1 year
Retinal neovascularization areas will be measured in mm2.
Structural OCT Cyst Volume
Time frame: 1 year
Cyst volume will be measured in mm3.
Structural OCT Retinal Thickening Area
Time frame: 1 year
The area of retinal thickening 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?
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?
PR-OCTA Measure of Non-Perfusion Areas (time frame: 3 years). The study lists 5 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.