search
Back to results

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

Primary Purpose

Diabetic Retinopathy, Retinal Vein Occlusion, Hypertension,Essential

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Swept-Source OCT Angiography
Spectral-Domain OCT Angiography
Fundus Imaging
Axial Length Measurement Device
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Diabetic Retinopathy

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Wilmer Eye InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Controls

Diabetics with and without Diabetic Retinopathy Only

Hypertension Only

Diabetics w/ or w/o Diabetic Retinopathy & Hypertension

Arm 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.

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

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.

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.

Outcomes

Primary Outcome Measures

Correlation of Imaging
Correlation of diagnostic imaging findings (vessel skeleton density) from OCT based images with disease stage

Secondary Outcome Measures

Full Information

First Posted
August 5, 2020
Last Updated
August 14, 2023
Sponsor
Johns Hopkins University
Collaborators
National Eye Institute (NEI)
search

1. Study Identification

Unique Protocol Identification Number
NCT04505618
Brief Title
Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease
Acronym
OCTA-RVD
Official Title
Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Eye Institute (NEI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Retinal Vein Occlusion, Hypertension,Essential, Retinal Vascular Disorder

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
1050 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Controls
Arm Type
Other
Arm 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.
Arm Title
Diabetics with and without Diabetic Retinopathy Only
Arm Type
Other
Arm Description
Subjects in this group only have diabetes with or without diabetic retinopathy. Some subjects in this arm will undergo retinal vascular reactivity assessments.
Arm Title
Hypertension Only
Arm Type
Other
Arm 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.
Arm Title
Diabetics w/ or w/o Diabetic Retinopathy & Hypertension
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
Swept-Source OCT Angiography
Other Intervention Name(s)
SS-OCTA
Intervention Description
Non-invasive, minimal risk, ocular imaging study
Intervention Type
Device
Intervention Name(s)
Spectral-Domain OCT Angiography
Other Intervention Name(s)
SD_OCTA
Intervention Description
Non-invasive, minimal risk, ocular imaging study
Intervention Type
Device
Intervention Name(s)
Fundus Imaging
Intervention Description
Non-invasive, minimal risk, ocular imaging study
Intervention Type
Device
Intervention Name(s)
Axial Length Measurement Device
Other Intervention Name(s)
IOL Master
Intervention Description
Non-invasive, minimal risk, ocular imaging study
Primary Outcome Measure Information:
Title
Correlation of Imaging
Description
Correlation of diagnostic imaging findings (vessel skeleton density) from OCT based images with disease stage
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amir H Kashani, MD, PhD
Phone
410-502-2789
Email
akashan1@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ana C Martinez, MPH
Phone
410-502-2789
Email
acollaz5@jhmi.edu
Facility Information:
Facility Name
Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
June Hall
Phone
410-502-2789
Email
jhall81@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Ana C Martinez
Email
acollaz5@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Amir H Kashani, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease

We'll reach out to this number within 24 hrs