WF and PR OCTA in Diabetic Retinopathy

NCT ID: NCT03922932

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 290 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-30
• Study Completion Date: 2027-12-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A: PDR

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

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Group C: DM without Retinopathy

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

No interventions assigned to this group

Group D: Healthy Controls

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

No interventions assigned to this group

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

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

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.)

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

David Huang

Thomas Hwang, MD, Associate Professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Hwang, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

OHSU IRB#00016932

Identifier Type: -

Identifier Source: org_study_id