WF and PR OCTA in Diabetic Retinopathy

September 5, 2025 updated by: David Huang, Oregon Health and Science University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
290

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Group A: PDR
This group will consist of 30 subjects with active proliferative diabetic retinopathy (PDR) and 30 subjects with treated PDR.
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.
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 60 subjects with diabetes mellitus (DM) who do not have retinopathy.
Group D: Healthy Controls
This group will consist of 50 subjects with healthy eyes who do not have diabetes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 years
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.
1 year
Non-PR-OCTA Retinal Neovascularization Areas
Time Frame: 1 year
Retinal neovascularization areas will be measured in mm2.
1 year
Structural OCT Cyst Volume
Time Frame: 1 year
Cyst volume will be measured in mm3.
1 year
Structural OCT Retinal Thickening Area
Time Frame: 1 year
The area of retinal thickening will be measured in mm2.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Health and Science University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Hwang, MD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OHSU IRB#00016932

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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