OCT Biomarkers for Diabetic Retinopathy

NCT ID: NCT02330042

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 165 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-26
• Study Completion Date: 2026-12-31

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.

Conditions

Diabetic Retinopathy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A

Patients with:

• Type 1 or Type 2 diabetes mellitus
• severe non-proliferative diabetic retinopathy (NPDR) or proliferative diabetic retinopathy (PDR).

No interventions assigned to this group

Group B

Patients with:

• Type 1 or Type 2 diabetes mellitus
• with or without mild to moderate NPDR

No interventions assigned to this group

Group C (controls)

Patients without diabetes or evidence of any form of eye disease

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

• Male or female participants 18-79 years old

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

David Huang

Thomas Hwang, MD, Professor of Ophthalmology, Retina & Vitreous Diseases Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Hwang, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

IRB#00010949

Identifier Type: -

Identifier Source: org_study_id