OCT Biomarkers for Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

Official title:

Functional Optical Coherence Tomography-Derived Biomarkers for Diabetic Retinopathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02330042
• Other study ID #: IRB#00010949
• Status: Active, not recruiting
• Start date: September 2014
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 165
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with decreased total retinal blood flow by OCT angiography	Total retinal blood flow will be measured in uL/min.	1 year
Primary	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
Primary	Number of participants with measureable macular edema by OCT imaging	Retinal thickening area will be measured in mm2.	1 year