Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease

Not Applicable

Recruiting

• Conditions: Diabetic Retinopathy; Hypertension,Essential; Retinal Vein Occlusion; Retinal Vascular Disorder
• Interventions: Device: Swept-Source (SS) OCT Angiography; Device: Spectral-Domain (SD) OCT Angiography; Device: Fundus Imaging; Device: Axial Length Measurement Device

• Registration Number: NCT04505618
• Lead Sponsor: Johns Hopkins University

Brief 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.

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-06-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1050

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Controls	Spectral-Domain (SD) OCT Angiography	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.
Hypertension Only	Spectral-Domain (SD) OCT Angiography	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.
Hypertension Only	Fundus Imaging	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.
Controls	Swept-Source (SS) OCT Angiography	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.
Diabetics with and without Diabetic Retinopathy Only	Swept-Source (SS) OCT Angiography	Subjects in this group only have diabetes with or without diabetic retinopathy. Some subjects in this arm will undergo retinal vascular reactivity assessments.
Hypertension Only	Swept-Source (SS) OCT Angiography	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.
Controls	Fundus Imaging	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.
Controls	Axial Length Measurement Device	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.
Diabetics with and without Diabetic Retinopathy Only	Spectral-Domain (SD) OCT Angiography	Subjects in this group only have diabetes with or without diabetic retinopathy. Some subjects in this arm will undergo retinal vascular reactivity assessments.
Diabetics with and without Diabetic Retinopathy Only	Fundus Imaging	Subjects in this group only have diabetes with or without diabetic retinopathy. Some subjects in this arm will undergo retinal vascular reactivity assessments.
Diabetics w/ or w/o Diabetic Retinopathy & Hypertension	Swept-Source (SS) OCT Angiography	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.
Diabetics w/ or w/o Diabetic Retinopathy & Hypertension	Axial Length Measurement Device	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.
Diabetics with and without Diabetic Retinopathy Only	Axial Length Measurement Device	Subjects in this group only have diabetes with or without diabetic retinopathy. Some subjects in this arm will undergo retinal vascular reactivity assessments.
Hypertension Only	Axial Length Measurement Device	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.
Diabetics w/ or w/o Diabetic Retinopathy & Hypertension	Fundus Imaging	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.
Diabetics w/ or w/o Diabetic Retinopathy & Hypertension	Spectral-Domain (SD) OCT Angiography	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.

Primary Outcome Measures

Name	Time	Method
Correlation of Imaging	5 years	Correlation of diagnostic imaging findings (vessel skeleton density) from OCT based images with disease stage

Trial Locations

Locations (1)

Wilmer Eye Institute; 🇺🇸 Baltimore, Maryland, United States