Retinal Vessel Leakage in Cerebral Small Vessel Disease (NCT06416371) | Clinical Trial Compass
RecruitingNot Applicable
Retinal Vessel Leakage in Cerebral Small Vessel Disease
United Kingdom40 participantsStarted 2025-01-13
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Any condition known to cause retinal leakage (i.e., worse than background diabetic retinopathy, retinal vein occlusion, active uveitis, wet age-related macular degeneration, malignant hypertension)
* Previous treatment for retinal leakage (retinal laser, intravitreal anti-VEGF)
* Recent eye surgery
* Shallow anterior chambers as assessed by torch test
* Pregnancy, renal failure
* Severe dementia
* Known allergy to fluorescein
* History of allergy such as food or drug induced urticaria or history of bronchial asthma
* Any other severe or acute medical or psychiatric conditions
* Inability to give informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.