NCT04505618

Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,050 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

This study will perform a prospective, longitudinal analysis of clinical and imaging findings from normal controls and subjects with retinal vascular disease to better define the diagnostic imaging criteria that signify change in disease stage. This includes disease progression in early stages of disease or disease regression with appropriate standard-of-care treatment.

Detailed description

The objective of this study is to perform a prospective, longitudinal analysis of clinical and imaging findings from normal controls and subjects with retinal vascular disease to better define the diagnostic imaging criteria that signify change in disease stage. This includes disease progression in early stages of disease or disease regression with appropriate standard-of-care treatment. Subjects will be identified from healthy subjects (seen for screening eye exams) and diseased subjects undergoing standard-of-care treatment or screening at eye clinic locations. The study population will include subjects with retinal vascular disease including but not limited to diabetic retinopathy, hypertension, retinal vein/arterial occlusion, and macular degeneration. Subjects who are enrolled will undergo non-invasive, minimal risk, FDA approved diagnostic imaging procedures to identify vascular changes. The study methods will include retrospective review and collection of clinically approved imaging data that is obtained through standard-of-care methods for subjects who meet inclusion and exclusion criteria. Subjects who are identified in this manner will be asked to participate in a prospective study by each clinical study site. The study end-points include the correlation of diagnostic imaging findings from Optical Coherence Tomography (OCT) based images with fundus photographs, clinical disease stage and visual acuity.

Conditions

• Diabetic Retinopathy
• Retinal Vein Occlusion
• Hypertension,Essential
• Retinal Vascular Disorder

Interventions

Type	Name	Description
DEVICE	Swept-Source (SS) OCT Angiography	Non-invasive, minimal risk, ocular imaging study
DEVICE	Spectral-Domain (SD) OCT Angiography	Non-invasive, minimal risk, ocular imaging study
DEVICE	Fundus Imaging	Non-invasive, minimal risk, ocular imaging study
DEVICE	Axial Length Measurement Device	Non-invasive, minimal risk, ocular imaging study

Timeline

• Start date: 2019-10-01
• Primary completion: 2026-06-01
• Completion: 2026-09-01
• First posted: 2020-08-10
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study