Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease (OCTA-RVD)

Johns Hopkins University

Status: Enrolling

Conditions: Hypertension,Essential; Retinal Vascular Disorder; Retinal Vein Occlusion; Diabetic Retinopathy

Treatments: Device: Swept-Source (SS) OCT Angiography; Device: Axial Length Measurement Device; Device: Spectral-Domain (SD) OCT Angiography; Device: Fundus Imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04505618

IRB00276904

R01EY030564 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,050 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Exclusion Criteria:

• Both subjects with diseases and controls:
• Children (age<18)
• Pregnant females
• Developmentally delayed subjects
• Subjects unable to provide informed consent
• Inability to cooperate with tests and study instructions
• Images with motion artifact or signal strength < 7
• History of glaucoma
• History of age-related macular degeneration
• History of any visually significant eye disease
• History of proliferative diabetic retinopathy
• History of any inflammatory disease
• History of heart disease
• History of thyroid disease.
• Additional criteria for controls:
• History of any type of Diabetes Mellitus
• History of any type of Hypertension

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,050 participants in 4 patient groups

Controls

Other group

Description:

Subjects in this group do not have any ocular pathology and are also not hypertensive. Some subjects in this arm will undergo retinal vascular reactivity assessments.

Treatment:

Device: Fundus Imaging

Device: Spectral-Domain (SD) OCT Angiography

Device: Axial Length Measurement Device

Device: Swept-Source (SS) OCT Angiography

Diabetics with and without Diabetic Retinopathy Only

Other group

Description:

Subjects in this group only have diabetes with or without diabetic retinopathy. Some subjects in this arm will undergo retinal vascular reactivity assessments.

Treatment:

Device: Fundus Imaging

Device: Spectral-Domain (SD) OCT Angiography

Device: Axial Length Measurement Device

Device: Swept-Source (SS) OCT Angiography

Hypertension Only

Other group

Description:

Subjects in this group only have hypertension with or without ocular pathology related to hypertension. Some subjects in this arm may undergo retinal vascular reactivity assessments.

Treatment:

Device: Fundus Imaging

Device: Spectral-Domain (SD) OCT Angiography

Device: Axial Length Measurement Device

Device: Swept-Source (SS) OCT Angiography

Diabetics w/ or w/o Diabetic Retinopathy & Hypertension

Other group

Description:

Subjects in this group have diabetes with or without diabetic retinopathy and hypertension with or without ocular pathology related to hypertension. Some subjects in this arm may undergo retinal vascular reactivity assessments.

Treatment:

Device: Fundus Imaging

Device: Spectral-Domain (SD) OCT Angiography

Device: Axial Length Measurement Device

Device: Swept-Source (SS) OCT Angiography