- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01998464
Optical Coherence Tomography (OCT) in Retinal Vasculitis
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- OHSU
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of retinal vasculitis
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Retinal Vasculitis Group
Up to 35 patients diagnosed with retinal vasculitis will be considered and evaluated for enrollment in this study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood flow patterns in retinal vasculitis
Time Frame: 24 months
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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.
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24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ischemia in retinal vasculitis
Time Frame: 24 months
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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.
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24 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Phoebe Lin, MD, PhD, Oregon Health and Science University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OHSU IRB#00010137
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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