At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Fundus fluorescein angiography, with ultrawide field retinal imaging (diagnostic test)
- How long the study runs
- Study runs about 49 months (dates as stated)
- About the drug or intervention
- Fundus fluorescein angiography, with ultrawide field retinal imaging — diagnostic test: Intravenous injection of sodium fluorescein for angiography of retinal blood vessels
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 40
- Started
- 2025-01-13
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for cerebral small vessel diseases
- • Clinical study - 40 participants
- • The goal of this observational study is to learn about leakage from retinal vessels in cerebral small vessel disease
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with cerebral small vessel diseases
Where?
- • Edinburgh - NHS Lothian
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The goal of this observational study is to learn about leakage from retinal vessels in cerebral small vessel disease. The main questions it aims to answer are: * Does retinal vessel leakage occur in cerebral small vessel disease? * If it does, is the severity of retinal vessel leakage similar to the severity of cerebral small vessel disease generally? Participants will be tested using fluorescein angiography. This involves an intravenous injection of fluorescent dye, and is a very sensitive way to find leakage from retinal blood vessels. Participants will have already had brain scans and other examinations and tests to measure the severity of their cerebral small vessel disease. Our new retinal images will complement the information from these previous tests.
More detail
Cerebral small vessel disease (SVD) is a common cause of stroke and dementia. The molecular causes are unclear, limiting new therapies. Breakdown of the blood-brain barrier (BBB) is characteristic and may damage brain tissue. However, specialist MRI scans to measure BBB breakdown are expensive and time-consuming. In contrast, measuring leakage from retinal blood vessels is relatively simple. The blood-retina barrier is very similar to the BBB, and SVD is likely to damage retinal and brain blood vessels in the same way. If so, then retinal angiography could be used to study SVD pathogenesis and measure the effect of new treatments with much greater resolution and lower cost than MRI. We have three aims: 1. Test the feasibility of fluorescein angiography in people with SVD 2. Discover if retinal vessel leakage occurs people with SVD 3. Discover whether the severity of retinal vessel leakage is associated with clinical features of SVD We will recruit participants from a well-established cohort of people with SVD - the Mild Stroke Study 3 (MSS3).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Membership in the Mild Stroke Study 3 cohort
- ✓Contrast enhanced MRI within 12 months
- ✓Clear optical media in both eyes, as assessed by study investigator
- ✓Best corrected visual acuity (near vision) ≥N36
Who cannot take part
- ✗Any condition known to cause retinal leakage (i.e., worse than background diabetic retinopathy, retinal vein...
- ✗Previous treatment for retinal leakage (retinal laser, intravitreal anti-VEGF)
- ✗Recent eye surgery
- ✗Shallow anterior chambers as assessed by torch test
- ✗Pregnancy, kidney failure
See the full criteria
Where Is This Study? (1 UK site)
NHS Lothian
Edinburgh, United Kingdom