Diabetic RetinopathyOCTA-RVDNCT04505618
Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease
A study testing Swept-Source (SS) OCT Angiography, Spectral-Domain (SD) OCT Angiography and Fundus Imaging in people with Diabetic Retinopathy and Retinal Vein Occlusion, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy, Retinal Vein Occlusion, Hypertension,Essential
- What is being tested?
- Swept-Source (SS) OCT Angiography, Spectral-Domain (SD) OCT Angiography and Fundus Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wilmer Eye Institute
Baltimore, Maryland, 21287
Ana Collazo Martinez, 410-502-5052, acollaz5@jhmi.edu
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About this study
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.
Read the 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.
- Conditions
- Diabetic Retinopathy, Retinal Vein Occlusion, Hypertension,Essential, Retinal Vascular Disorder
- Being tested
- Swept-Source (SS) OCT Angiography, Spectral-Domain (SD) OCT Angiography, Fundus Imaging, Axial Length Measurement Device
- Medical subject headings
- Diabetic Retinopathy, Retinal Vein Occlusion, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swept-Source (SS) OCT AngiographyDevice
Also called SS-OCTA
Non-invasive, minimal risk, ocular imaging study
Spectral-Domain (SD) OCT AngiographyDevice
Also called SD_OCTA
Non-invasive, minimal risk, ocular imaging study
Fundus ImagingDevice
Non-invasive, minimal risk, ocular imaging study
Axial Length Measurement DeviceDevice
Also called Intraocular Lens (IOL) Master
Non-invasive, minimal risk, ocular imaging study
| Study group | Role | What they receive |
|---|---|---|
| Controls | Other | 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. Receives: Device: Swept-Source (SS) OCT Angiography; Device: Spectral-Domain (SD) OCT Angiography; Device: Fundus Imaging; Device: Axial Length Measurement Device |
| Diabetics with and without Diabetic Retinopathy Only | Other | Subjects in this group only have diabetes with or without diabetic retinopathy. Some subjects in this arm will undergo retinal vascular reactivity assessments. Receives: Device: Swept-Source (SS) OCT Angiography; Device: Spectral-Domain (SD) OCT Angiography; Device: Fundus Imaging; Device: Axial Length Measurement Device |
| Hypertension Only | Other | 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. Receives: Device: Swept-Source (SS) OCT Angiography; Device: Spectral-Domain (SD) OCT Angiography; Device: Fundus Imaging; Device: Axial Length Measurement Device |
| Diabetics w/ or w/o Diabetic Retinopathy & Hypertension | Other | 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. Receives: Device: Swept-Source (SS) OCT Angiography; Device: Spectral-Domain (SD) OCT Angiography; Device: Fundus Imaging; Device: Axial Length Measurement Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Imaging
Correlation of diagnostic imaging findings (vessel skeleton density) from OCT based images with disease stage
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Oct 2019
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Amir Kashani, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505618
- Sponsor's protocol ID
- IRB00276904
- Other IDs
- R01EY030564
- Acronym
- OCTA-RVD
- Status last verified
- Jun 2026
- First submitted
- 5 Aug 2020
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease
- ClinicalTrials.gov ID
- NCT04505618
- Acronym / sponsor ID
- OCTA-RVD / IRB00276904
- Conditions
- Diabetic Retinopathy, Retinal Vein Occlusion, Hypertension,Essential, Retinal Vascular Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Controls | Other | Device: Swept-Source (SS) OCT Angiography, Device: Spectral-Domain (SD) OCT Angiography, Device: Fundus Imaging, Device: Axial Length Measurement DeviceSubjects 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 | Other | Device: Swept-Source (SS) OCT Angiography, Device: Spectral-Domain (SD) OCT Angiography, Device: Fundus Imaging, Device: Axial Length Measurement DeviceSubjects in this group only have diabetes with or without diabetic retinopathy. Some subjects in this arm will undergo retinal vascular reactivity assessments. |
| Hypertension Only | Other | Device: Swept-Source (SS) OCT Angiography, Device: Spectral-Domain (SD) OCT Angiography, Device: Fundus Imaging, Device: Axial Length Measurement DeviceSubjects 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 | Other | Device: Swept-Source (SS) OCT Angiography, Device: Spectral-Domain (SD) OCT Angiography, Device: Fundus Imaging, Device: Axial Length Measurement DeviceSubjects 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- Both subjects with diseases and controls:
- Children (age<18)
- Pregnant females
- Developmentally delayed subjects
- Subjects unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swept-Source (SS) OCT AngiographyAlso: SS-OCTANon-invasive, minimal risk, ocular imaging study | Device | Controls, Diabetics w/ or w/o Diabetic Retinopathy & Hypertension, Diabetics with and without Diabetic Retinopathy Only, Hypertension Only |
| Spectral-Domain (SD) OCT AngiographyAlso: SD_OCTANon-invasive, minimal risk, ocular imaging study | Device | Controls, Diabetics w/ or w/o Diabetic Retinopathy & Hypertension, Diabetics with and without Diabetic Retinopathy Only, Hypertension Only |
| Fundus ImagingNon-invasive, minimal risk, ocular imaging study | Device | Controls, Diabetics w/ or w/o Diabetic Retinopathy & Hypertension, Diabetics with and without Diabetic Retinopathy Only, Hypertension Only |
| Axial Length Measurement DeviceAlso: Intraocular Lens (IOL) MasterNon-invasive, minimal risk, ocular imaging study | Device | Controls, Diabetics w/ or w/o Diabetic Retinopathy & Hypertension, Diabetics with and without Diabetic Retinopathy Only, Hypertension Only |
Primary outcome
Correlation of Imaging
Time frame: 5 years
Correlation of diagnostic imaging findings (vessel skeleton density) from OCT based images with disease stage
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amir Kashani, MD, MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swept-Source (SS) OCT Angiography, Spectral-Domain (SD) OCT Angiography and Fundus Imaging in people with Diabetic Retinopathy and Retinal Vein Occlusion, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amir H Kashani, MD, PhD (410-502-2789, akashan1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of Imaging (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.