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Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease

Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04505618
Acronym
OCTA-RVD
Enrollment
1050
Registered
2020-08-10
Start date
2019-10-01
Completion date
2027-09-01
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICESwept-Source (SS) OCT Angiography

Non-invasive, minimal risk, ocular imaging study

DEVICESpectral-Domain (SD) OCT Angiography

Non-invasive, minimal risk, ocular imaging study

Non-invasive, minimal risk, ocular imaging study

DEVICEAxial Length Measurement Device

Non-invasive, minimal risk, ocular imaging study

Sponsors

Johns Hopkins University
Lead SponsorOTHER
National Eye Institute (NEI)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation of Imaging5 yearsCorrelation of diagnostic imaging findings (vessel skeleton density) from OCT based images with disease stage

Countries

United States

Contacts

CONTACTAmir H Kashani, MD, PhD
akashan1@jhmi.edu410-502-2789
CONTACTAna C Martinez, MPH
acollaz5@jhmi.edu410-502-2789
PRINCIPAL_INVESTIGATORAmir Kashani, MD, MPH

Johns Hopkins University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026