NCT02330042

Brief Summary

Diabetic retinopathy (DR) is caused by changes in the blood vessels of the retina associated with long-term Type 1 or Type 2 diabetes mellitus. DR is a leading cause of blindness in the United States. Standard optical coherence tomography (OCT) cannot directly detect vascular changes, which may occur early affecting the passage of blood through the tiny capillaries (reduced capillary flow) or cause the greatest damage through formation of abnormal blood vessel growth (neovascularization). Currently, fluorescein angiography (FA) is the gold standard for detecting these changes, but FA requires an injection of a dye into the vein of the arm of the patient. This dye can cause undesirable side effects. Recently, OCT has been used to make functional measurements (such as total retinal blood flow among others) and to perform angiography. Thus, functional OCT may provide a useful, alternate way to evaluate diabetic retinopathy.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jan 2015Dec 2026

First Submitted

Initial submission to the registry

December 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 1, 2015

Completed
25 days until next milestone

Study Start

First participant enrolled

January 26, 2015

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2020

Completed
6.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

5.1 years

First QC Date

December 30, 2014

Last Update Submit

September 5, 2025

Conditions

Diabetic Retinopathy

Keywords

DiabetesOCTAngiographyDiabetic retinopathy

Outcome Measures

Primary Outcomes (3)

  • Number of participants with decreased total retinal blood flow by OCT angiography

    Total retinal blood flow will be measured in uL/min.

    1 year

  • Number of participants with capillary dropout and/or new abnormal retinal blood vessel growth by OCT angiography

    Neovascular membrane area will be measured in mm2.

    1 year

  • Number of participants with measureable macular edema by OCT imaging

    Retinal thickening area will be measured in mm2.

    1 year

Study Arms (3)

Group A

Patients with: * Type 1 or Type 2 diabetes mellitus * severe non-proliferative diabetic retinopathy (NPDR) or proliferative diabetic retinopathy (PDR).

Group B

Patients with: * Type 1 or Type 2 diabetes mellitus * with or without mild to moderate NPDR

Group C (controls)

Patients without diabetes or evidence of any form of eye disease

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants with Type 1 diabetes of greater than 5 years duration OR Type 2 diabetes of any duration. Healthy controls are also being enrolled in this study.

You may qualify if:

  • Male or female participants 18-79 years old
  • With Type 1 diabetes for over 5 years or Type 2 diabetes of any duration

You may not qualify if:

  • Vision worse than 20/200
  • Inability to maintain fixation for OCT imaging
  • Significant kidney disease, kidney failure or kidney transplant
  • Unstable medical status, including blood pressure greater than 180/110 or unstable heart disease
  • Pregnant or nursing an infant
  • Presence of an eye disease (other than diabetic retinopathy) that can affect retinal blood flow, retinal permeability or retinal anatomy
  • Significant cataract, corneal scar, vitreous bleed or other media opacity
  • History of major eye surgery within 4 months prior to enrollment in this study
  • Male or female participants 18-79 years old
  • Vision worse than 20/200
  • Inability to maintain fixation for OCT imaging
  • Significant kidney disease, kidney failure or kidney transplant
  • Unstable medical status, including blood pressure greater than 180/110 or unstable heart disease
  • Pregnant or nursing an infant
  • Presence of any eye disease that can affect retinal blood flow, retinal permeability or retinal anatomy
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Diabetic RetinopathyDiabetes Mellitus

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Thomas Hwang, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Thomas Hwang, MD, Professor of Ophthalmology, Retina & Vitreous Diseases Division

Study Record Dates

First Submitted

December 30, 2014

First Posted

January 1, 2015

Study Start

January 26, 2015

Primary Completion

February 24, 2020

Study Completion (Estimated)

December 1, 2026

Last Updated

September 9, 2025

Record last verified: 2025-09

Locations

US(1)