NCT03922932Active, not recruiting
WF and PR OCTA in Diabetic Retinopathy
Wide-Field and Projection-Resolved Optical Coherence Tomography Angiography in Diabetic Retinopathy
Source: ClinicalTrials.gov · Last updated 9 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 290 (estimated)
- First submitted
- 18 Apr 2019
- Start date
- 30 Aug 2017
- Primary completion date
- Jun 2026
- Lead sponsor
- Oregon Health and Science University
- Diseases
- Diabetic eye disease
- NCT number
- NCT03922932
What you commit to
- Study type: Observational
- Planned participants: 290
- From 30 Aug 2017 to the primary completion date, Jun 2026
- 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.
Criteria the registry did not label
- 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
- Group B:
- NPDR of any severity as defined by the International Clinical Diabetic Retinopathy Severity Scale
- Groups C \& D:
- No evidence of diabetic retinopathy
- 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
Age in the registry: 18 years to - · 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.