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 range18 Years

SexALL

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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

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 range18 Years

SexALL

See this in plain English?

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