Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease
OCTA-RVD
2 other identifiers
interventional
1,050
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
August 5, 2020
CompletedFirst Posted
Study publicly available on registry
August 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
March 9, 2026
March 1, 2026
6.7 years
August 5, 2020
March 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Correlation of Imaging
Correlation of diagnostic imaging findings (vessel skeleton density) from OCT based images with disease stage
5 years
Study Arms (4)
Controls
OTHERSubjects 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
OTHERSubjects in this group only have diabetes with or without diabetic retinopathy. Some subjects in this arm will undergo retinal vascular reactivity assessments.
Hypertension Only
OTHERSubjects 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
OTHERSubjects 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.
Interventions
Non-invasive, minimal risk, ocular imaging study
Non-invasive, minimal risk, ocular imaging study
Non-invasive, minimal risk, ocular imaging study
Non-invasive, minimal risk, ocular imaging study
Eligibility Criteria
You may not qualify if:
- 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:
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Eye Institute (NEI)collaborator
- Johns Hopkins Universitylead
Study Sites (1)
Wilmer Eye Institute
Baltimore, Maryland, 21287, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amir Kashani, MD, MPH
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2020
First Posted
August 10, 2020
Study Start
October 1, 2019
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
March 9, 2026
Record last verified: 2026-03