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New eye scan could replace dye tests for Diabetes-Related vision loss

NCT ID NCT03922932

Knowledge-focused Sponsor: Oregon Health and Science University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a new type of eye scan called OCT angiography (OCTA) to see if it can better measure damage from diabetic retinopathy, a leading cause of vision loss. Researchers will compare OCTA images to standard dye-based tests in 290 people with diabetes. The goal is to find a safer, faster, and more objective way to diagnose and monitor the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a safer, faster, and more objective way to diagnose and monitor diabetic retinopathy, replacing dye-based tests.
What could go wrong
This is an observational study, not a treatment trial. The new imaging method may not prove better than current techniques, and results may not change clinical practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 290 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2017

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults age 18 or older with either healthy eyes or diabetic retinopathy

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetes mellitus diabetic retinopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic retinopathy

Contacts and locations

Locations

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.