Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03922932

WF and PR OCTA 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. Non-PR-OCTA Retinal Neovascularization Areas

    Time frame: 1 year

    Retinal neovascularization areas will be measured in mm2.

  4. Structural OCT Cyst Volume

    Time frame: 1 year

    Cyst volume will be measured in mm3.

  5. Structural OCT Retinal Thickening Area

    Time frame: 1 year

    The area of retinal thickening will be measured in mm2.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Wide-Field and Projection-Resolved Optical Coherence Tomography Angiography in Diabetic Retinopathy

Important dates

Study start
2017
Primary completion
2026
Study completion
2027
First posted
Apr 22, 2019
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.