WF and PR OCTA in Diabetic Retinopathy

Sponsor

Oregon Health and Science University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03922932

Collaborator

(none)

290

Enrollment

Location

87.1

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy

Study Design

Study Type:

Observational

Anticipated Enrollment :

290 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 30, 2017

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Group A: PDR This group will consist of 25 subjects with active proliferative diabetic retinopathy (PDR) and 25 subjects with treated PDR.
Group B: NPDR This group will consist of 50 subjects with severe non-proliferative diabetic retinopathy (NPDR), 50 subjects with moderate NPDR, and 50 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 50 subjects with diabetes mellitus (DM) who do not have retinopathy.
Group D: Healthy Controls This group will consist of 40 subjects with healthy eyes who do not have diabetes.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Participant-Related Inclusion Criteria:

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:

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