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Clinical Trials/NCT03922932
NCT03922932
Active, not recruiting
Not Applicable

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

Oregon Health and Science University1 site in 1 country290 target enrollmentAugust 30, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Retinopathy
Sponsor
Oregon Health and Science University
Enrollment
290
Locations
1
Primary Endpoint
Structural OCT Cyst Volume
Status
Active, not recruiting
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 30, 2017
End Date
December 1, 2027
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Huang

Thomas Hwang, MD, Associate Professor of Ophthalmology

Oregon Health and Science University

Eligibility Criteria

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

  • 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

Outcomes

Primary Outcomes

Structural OCT Cyst Volume

Time Frame: 1 year

Cyst volume will be measured in mm3.

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.

Structural OCT Retinal Thickening Area

Time Frame: 1 year

The area of retinal thickening will be measured in mm2.

Non-PR-OCTA Retinal Neovascularization Areas

Time Frame: 1 year

Retinal neovascularization areas will be measured in mm2.

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.

Study Sites (1)

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