WF and PR OCTA in Diabetic Retinopathy

Oregon Health & Science University (OHSU)

Status: Active, not recruiting

Conditions: Diabetic Retinopathy

Study type: Observational

Funder types: Other

Identifiers

NCT03922932

OHSU IRB#00016932

Details and patient eligibility

About

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.

Enrollment: 290 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

290 participants in 5 patient groups

Group A: PDR

Description:

This group will consist of 30 subjects with active proliferative diabetic retinopathy (PDR) and 30 subjects with treated PDR.

Group B: NPDR

Description:

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

Description:

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

Description:

This group will consist of 60 subjects with diabetes mellitus (DM) who do not have retinopathy.

Group D: Healthy Controls

Description:

This group will consist of 50 subjects with healthy eyes who do not have diabetes.