Overview

This trial is active, not recruiting.

Condition diabetic retinopathy
Sponsor Oregon Health and Science University
Start date September 2014
End date January 2017
Trial size 215 participants
Trial identifier NCT02330042, IRB#00010949

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Patients with: Type 1 or Type 2 diabetes mellitus severe non-proliferative diabetic retinopathy (NPDR) or proliferative diabetic retinopathy (PDR).
Patients with: Type 1 or Type 2 diabetes mellitus with or without mild to moderate NPDR
Patients without diabetes or evidence of any form of eye disease

Primary Outcomes

Measure
Number of participants with decreased total retinal blood flow by OCT angiography
time frame: 1 year
Number of participants with capillary dropout and/or new abnormal retinal blood vessel growth by OCT angiography
time frame: 1 year
Number of participants with measureable macular edema by OCT imaging
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 79 years old.

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

Additional Information

Official title Functional Optical Coherence Tomography-Derived Biomarkers for Diabetic Retinopathy
Principal investigator Yali Jia, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Oregon Health and Science University.