OCT Biomarkers for Diabetic Retinopathy

Sponsor

Oregon Health and Science University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02330042

Collaborator

(none)

165

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy

Study Design

Study Type:

Observational

Actual Enrollment :

165 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Functional Optical Coherence Tomography-Derived Biomarkers for Diabetic Retinopathy

Study Start Date :

Sep 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Number of participants with decreased total retinal blood flow by OCT angiography [1 year]
Total retinal blood flow will be measured in uL/min.
Number of participants with capillary dropout and/or new abnormal retinal blood vessel growth by OCT angiography [1 year]
Neovascular membrane area will be measured in mm2.
Number of participants with measureable macular edema by OCT imaging [1 year]
Retinal thickening area will be measured in mm2.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria for participants with diabetes:

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

Exclusion Criteria for participants with diabetes:

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

Inclusion Criteria for participants without diabetes (controls):

Male or female participants 18-79 years old

Exclusion Criteria for participants without diabetes (controls):

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
Significant cataract, corneal scar, vitreous bleed or other media opacity
History of major eye surgery within 4 months prior to enrollment in this study