WF and PR OCTA in Diabetic Retinopathy

NCT03922932 | Active Not Recruiting

• 1 other identifier: OHSU IRB#00016932
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Retinopathy

Keywords

Diabetes; OCT; Angiography; Diabetic retinopathy

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (5)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.)
• 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
• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas Hwang, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thomas Hwang, MD, Associate Professor of Ophthalmology

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 22, 2019
• Study Start: August 30, 2017
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

US (1)