Active — Not RecruitingNot Applicable

WF and PR OCTA in Diabetic Retinopathy

United States290 participantsStarted 2017-08-30

Plain-language 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). 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Participant-Related Inclusion Criteria: I. 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: I. 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: I. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PR-OCTA Measure of Non-Perfusion Areas

Timeframe: 3 years

Non-PR-OCTA Measure of Retinal Non-Perfusion Areas

Timeframe: 1 year

Non-PR-OCTA Retinal Neovascularization Areas

Timeframe: 1 year

Structural OCT Cyst Volume

Timeframe: 1 year

Structural OCT Retinal Thickening Area

Timeframe: 1 year

Trial details

NCT IDNCT03922932

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06

View on ClinicalTrials.gov More Diabetic Retinopathy trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.