Clinical trial NCT03922932: WF and PR OCTA in Diabetic Retinopathy
Official title: Wide-Field and Projection-Resolved Optical Coherence Tomography Angiography in Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetic Retinopathy
Keywords: Diabetes
OCT
Angiography
Diabetic retinopathy
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults age 18 or older with either healthy eyes or diabetic retinopathy

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.


Eligibility criteria: 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

Primary outcomes:
measure: PR-OCTA Measure of Non-Perfusion Areas
timeFrame: 3 years
measure: Non-PR-OCTA Measure of Retinal Non-Perfusion Areas
timeFrame: 1 year
measure: Non-PR-OCTA Retinal Neovascularization Areas
timeFrame: 1 year
measure: Structural OCT Cyst Volume
timeFrame: 1 year
measure: Structural OCT Retinal Thickening Area
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Thomas Hwang, MD
role: PRINCIPAL_INVESTIGATOR
References: