NCT06416371

Retinal Vessel Leakage in Cerebral Small Vessel Disease

Retinal Vessel Leakage in Cerebral Small Vessel Disease: a Sub-study of the Mild Stroke Study 3

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: University of Edinburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Cerebral Small Vessel Diseases
• Lacunar Stroke
• Vascular Dementia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Fundus fluorescein angiography, with ultrawide field retinal imaging	Intravenous injection of sodium fluorescein for angiography of retinal blood vessels

Timeline

• Start date: 2025-01-13
• Primary completion: 2029-02-15
• Completion: 2029-02-15
• First posted: 2024-05-16
• Last updated: 2026-03-04

Locations

1 site across 1 country: United Kingdom