WF and PR OCTA in Diabetic Retinopathy

Wide-Field and Projection-Resolved Optical Coherence Tomography Angiography 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Retinopathy

• Study Type: Observational
• Enrollment (Estimated): 290

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Group A: PDR; This group will consist of 30 subjects with active proliferative diabetic retinopathy (PDR) and 30 subjects with treated PDR.
Group B: NPDR; This group will consist of 60 subjects with severe non-proliferative diabetic retinopathy (NPDR), 60 subjects with moderate NPDR, and 60 subjects with mild NPDR.
Group ME: Macular Edema; This group is a sub-set of 25 subjects from either Group A or B who have macular edema requiring treatment.
Group C: DM without Retinopathy; This group will consist of 60 subjects with diabetes mellitus (DM) who do not have retinopathy.
Group D: Healthy Controls; This group will consist of 50 subjects with healthy eyes who do not have diabetes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PR-OCTA Measure of Non-Perfusion Areas	Non-perfusion areas of the 3 retinal plexuses and choriocapillaris will be measured in mm2.	3 years
Non-PR-OCTA Measure of Retinal Non-Perfusion Areas	Non-perfusion areas of the 3 retinal plexuses will be measured in mm2.	1 year
Non-PR-OCTA Retinal Neovascularization Areas	Retinal neovascularization areas will be measured in mm2.	1 year
Structural OCT Cyst Volume	Cyst volume will be measured in mm3.	1 year
Structural OCT Retinal Thickening Area	The area of retinal thickening will be measured in mm2.	1 year

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Thomas Hwang, MD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2017
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 18, 2019
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (Actual): April 22, 2019

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes; OCT; Diabetic retinopathy; Angiography
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Eye Diseases; Diabetic Angiopathies; Diabetes Complications; Retinal Diseases; Nutritional and Metabolic Diseases; Diabetic Retinopathy; Diabetes Mellitus
• Other Study ID Numbers: OHSU IRB#00016932

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No