WF and PR OCTA in Diabetic Retinopathy

• ClinicalTrials.gov Identifier: NCT03922932
• Recruitment Status: Recruiting
• First Posted: April 22, 2019
• Last Update Posted: September 16, 2020
• Sponsor: Oregon Health and Science University
• Information provided by (Responsible Party): David Huang, Oregon Health and Science University

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
Diabetic Retinopathy

Study Design

• Study Type: Observational
• Estimated 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: August 30, 2017
• Estimated Primary Completion Date: December 2023
• Estimated Study Completion Date: December 2023

Groups and Cohorts

Group/Cohort
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 :

1. 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.
2. 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.
3. Non-PR-OCTA Retinal Neovascularization Areas [ Time Frame: 1 year ]
   Retinal neovascularization areas will be measured in mm2.
4. Structural OCT Cyst Volume [ Time Frame: 1 year ]
   Cyst volume will be measured in mm3.
5. Structural OCT Retinal Thickening Area [ Time Frame: 1 year ]
   The area of retinal thickening will be measured in mm2.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Adults age 18 or older with either healthy eyes or diabetic retinopathy

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

Contacts and Locations

Contacts

Contact: Denzil Romfh, OD; 503-494-4351; romfhd@ohsu.edu

Contact: George Pacheco, COA; 503-494-7398; pachecge@ohsu.edu

Locations

United States, Oregon

Oregon Health & Science University; Recruiting

Portland, Oregon, United States, 97239

Contact: Denzil Romfh, OD 503-494-4351 romfhd@ohsu.edu

Contact: George Pacheco, COA 503-494-7398 pachecge@ohsu.edu

Sub-Investigator: David Wilson, MD

Sub-Investigator: Andreas Lauer, MD

Sub-Investigator: Steve Bailey, MD

Sub-Investigator: Phoebe Lin, MD, PhD

Sub-Investigator: John P Campbell, MD, PhD

Sub-Investigator: Christina Flaxel, MD

Sub-Investigator: Kavita Bhavsar, MD

Sub-Investigator: Matthew Duggan, MD

Sub-Investigator: Rene Choi, MD, PhD

Sub-Investigator: Stanford Taylor, MD

Sponsors and Collaborators

Oregon Health and Science University

Investigators

• Principal Investigator: Thomas Hwang, MD; Oregon Health and Science University

More Information

• Responsible Party: David Huang, Thomas Hwang, MD, Associate Professor of Ophthalmology, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT03922932
• Other Study ID Numbers: OHSU IRB#00016932
• First Posted: April 22, 2019
• Last Update Posted: September 16, 2020
• Last Verified: September 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by David Huang, Oregon Health and Science University:

Diabetes; OCT; Angiography; Diabetic retinopathy

Additional relevant MeSH terms:

Retinal Diseases; Diabetic Retinopathy; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases