Retinal VasculitisNCT01998464
Optical Coherence Tomography (OCT) in Retinal Vasculitis
An observational study of Retinal Vasculitis, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Retinal vasculitis is a sight-threatening inflammation that involves the blood vessels of the retina, the tissue that lines the inside of the eye. This inflammation may occur on its own or as a result of an infectious, cancerous, or inflammatory disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vasculitis
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 23 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will measure blood vessel pattern/flow changes in up to 35 patients with retinal vasculitis.
Who may be able to join
- Diagnosis of retinal vasculitis
Who cannot join
- Inability to give informed consent.
- Inability to complete the qualifying study tests within a 30 day period from date of enrollment
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- A prior history of reaction to fluorescein or other dyes.
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g. unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
- Blood pressure > 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible.
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- Systemic anti-vascular endothelial growth factor (VEGF) or pro-VEGF treatment within 4 months prior to treatment.
- Women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months due to unknown safety of fluorescein angiography.
- Prior panretinal photocoagulation (PRP) or focal laser that would alter the macular perfusion and retinovascular features.
- Inability to maintain stable fixation for OCT imaging.
- Other ocular condition is present such that, in the opinion of the investigator, may alter the retinal perfusion.
- An ocular condition is present that, in the opinion of the investigator, might affect or alter visual acuity during the course of the study (i.e. cataract)
- Substantial cataract that, in the opinion of the investigator, is likely to decrease visual acuity by 3 lines or more (i.e. cataract would be reducing acuity to 20/40 or worse if the eye was otherwise normal).
- Media opacity or otherwise that would prevent either fixation or ability to obtain adequate images as determined by the examiner.
- History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc) within prior 4 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Utility of OCT Angiography in Assessing Vascular Perfusion in Retinal Vasculitis
Retinal vasculitis is a sight-threatening inflammation that involves the blood vessels of the retina, the tissue that lines the inside of the eye. This inflammation may occur on its own or as a result of an infectious, cancerous, or inflammatory disorder.
Optical coherence tomography (OCT) is an imaging technology that can perform non-contact cross-sectional imaging of retinal and choroidal tissue structure in real time. It is similar to ultrasound imaging, except that OCT measures the intensity of reflected light rather than sound waves.
The purpose of this study is to see if non-invasive OCT technology can diagnose retinal vasculitis as well as the more invasive fluorescein angiography, which requires an injection of dye into the vein of an arm of a patient. The study will also compare the mapping of blood vessels (angiography) and loss of blood flow (ischemia) by fluorescein angiography and OCT.
- Conditions
- Retinal Vasculitis
- Keywords
- Retinal Vasculitis, Optical coherence tomography, OCT, Imaging
- Medical subject headings
- Retinal Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retinal Vasculitis Group | Up to 35 patients diagnosed with retinal vasculitis will be considered and evaluated for enrollment in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow patterns in retinal vasculitis
To determine if identifying early changes in blood vessel patterns will aid in early diagnosis and treatment of retinal vasculitis. Total retinal blood flow will be measured in uL/min.
Measured: 24 months
Secondary outcomes (1)
Ischemia in retinal vasculitis
To determine if identifying lost or reduced blood flow will aid in early diagnosis and treatment of retinal vasculitis. Non-perfusion area will be measured in mm2.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2013 (estimated)
- Study startJan 2014
- Primary completion23 Aug 2018
- Study completion23 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal VasculitisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Huang, Oregon Health and Science University
- Investigators
- Phoebe Lin, MD, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998464
- Sponsor's protocol ID
- OHSU IRB#00010137
- Status last verified
- Feb 2024
- First submitted
- 18 Nov 2013
- Last updated
- 12 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Utility of OCT Angiography in Assessing Vascular Perfusion in Retinal Vasculitis
- ClinicalTrials.gov ID
- NCT01998464
- Acronym / sponsor ID
- OHSU IRB#00010137
- Conditions
- Retinal Vasculitis
- Keywords
- Retinal Vasculitis, Optical coherence tomography, OCT, Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 23 Aug 2018 (actual)
- Study completion
- 23 Aug 2018 (actual)
- First posted
- 29 Nov 2013 (estimated)
- 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.
Retinal vasculitis is a sight-threatening inflammation that involves the blood vessels of the retina, the tissue that lines the inside of the eye. This inflammation may occur on its own or as a result of an infectious, cancerous, or inflammatory disorder.
Optical coherence tomography (OCT) is an imaging technology that can perform non-contact cross-sectional imaging of retinal and choroidal tissue structure in real time. It is similar to ultrasound imaging, except that OCT measures the intensity of reflected light rather than sound waves.
The purpose of this study is to see if non-invasive OCT technology can diagnose retinal vasculitis as well as the more invasive fluorescein angiography, which requires an injection of dye into the vein of an arm of a patient. The study will also compare the mapping of blood vessels (angiography) and loss of blood flow (ischemia) by fluorescein angiography and OCT.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retinal Vasculitis Group | – | –Up to 35 patients diagnosed with retinal vasculitis will be considered and evaluated for enrollment in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will measure blood vessel pattern/flow changes in up to 35 patients with retinal vasculitis.
Key inclusion criteria (1 listed)
- Diagnosis of retinal vasculitis
Key exclusion criteria (15 listed)
- Inability to give informed consent.
- Inability to complete the qualifying study tests within a 30 day period from date of enrollment
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- A prior history of reaction to fluorescein or other dyes.
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g. unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood flow patterns in retinal vasculitis
Time frame: 24 months
To determine if identifying early changes in blood vessel patterns will aid in early diagnosis and treatment of retinal vasculitis. Total retinal blood flow will be measured in uL/min.
1 secondary outcome
Ischemia in retinal vasculitis
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
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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. This study is not recruiting at the moment.
Phoebe Lin, MD, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Vasculitis, run by Oregon Health and Science 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 1 inclusion and 15 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: finished, as of the sponsor's last update on 12 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood flow patterns in retinal vasculitis (time frame: 24 months). 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 12 Feb 2024.