Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease

Diabetic Retinopathy Clinical Trial

— OCTA-RVD  

Official title:

Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04505618
• Other study ID #: IRB00276904
• Secondary ID: R01EY030564
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: September 1, 2025

Study information

• Verified date: August 2023
• Source: Johns Hopkins University
• Contact: Amir H Kashani, MD, PhD
• Phone: 410-502-2789
• Email: akashan1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 OCT based images with fundus photographs, clinical disease stage and visual acuity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1050
• Est. completion date: September 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Swept-Source OCT Angiography
Non-invasive, minimal risk, ocular imaging study
• Spectral-Domain OCT Angiography
Non-invasive, minimal risk, ocular imaging study
• Fundus Imaging
Non-invasive, minimal risk, ocular imaging study
• Axial Length Measurement Device
Non-invasive, minimal risk, ocular imaging study

Locations

Country	Name	City	State
United States	Wilmer Eye Institute	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of Imaging	Correlation of diagnostic imaging findings (vessel skeleton density) from OCT based images with disease stage	5 years