Retinal Vessel Leakage in Cerebral Small Vessel Disease

NCT06416371 | Recruiting

• 1 other identifier: AC24000
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Small Vessel Diseases; Lacunar Stroke; Vascular Dementia

Outcome Measures

Primary Outcomes (2)

• Retinal vessel leakage by automated segmentation

  The presence and severity of retinal vessel leakage will be measured for each eye in terms of change in pixel brightness over the duration of the angiogram.

  within one angiogram

• Retinal vessel leakage by manual grading

  The presence and severity of retinal vessel leakage will be measured using an manual ordinal grading scale

  within one angiogram

Secondary Outcomes (8)

• Baseline blood-brain barrier breakdown

  Within one MRI scan

• White matter hyperintensity (WMH) volume adjusted for brain volume

  Within one MRI scan

• Change in white matter hyperintensity (WMH) volume adjusted for brain volume

  Difference in MRI scans up to 5 years prior

• Fazekas score

  Within one MRI scan

• Change in Fazekas score

  Difference in MRI scans up to 5 years prior

Interventions

Fundus fluorescein angiography, with ultrawide field retinal imaging DIAGNOSTIC_TEST

Intravenous injection of sodium fluorescein for angiography of retinal blood vessels

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults \>18 years old with mild ischaemic stroke with a modified Rankin scale (mRS) greater or equal to 2 at recruitment presenting to Edinburgh/Lothian stroke services. For details see Clancy, et al (2021) Rationale and design of a longitudinal study of cerebral small vessel diseases, clinical and imaging outcomes in patients presenting with mild ischaemic stroke: Mild Stroke Study 3. European Stroke Journal 6:81-88. https://doi.org/10.1177/2396987320929617

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

NHS Lothian

Edinburgh, United Kingdom

RECRUITING

Related Publications (2)

• Clancy U, Garcia DJ, Stringer MS, Thrippleton MJ, Valdes-Hernandez MC, Wiseman S, Hamilton OK, Chappell FM, Brown R, Blair GW, Hewins W, Sleight E, Ballerini L, Bastin ME, Maniega SM, MacGillivray T, Hetherington K, Hamid C, Arteaga C, Morgan AG, Manning C, Backhouse E, Hamilton I, Job D, Marshall I, Doubal FN, Wardlaw JM. Rationale and design of a longitudinal study of cerebral small vessel diseases, clinical and imaging outcomes in patients presenting with mild ischaemic stroke: Mild Stroke Study 3. Eur Stroke J. 2021 Mar;6(1):81-88. doi: 10.1177/2396987320929617. Epub 2020 Jun 5.

  PMID: 33817338 BACKGROUND

• MacCormick IJ, Maude RJ, Beare NA, Borooah S, Glover S, Parry D, Leach S, Molyneux ME, Dhillon B, Lewallen S, Harding SP. Grading fluorescein angiograms in malarial retinopathy. Malar J. 2015 Sep 24;14:367. doi: 10.1186/s12936-015-0897-7.

  PMID: 26403288 BACKGROUND

MeSH Terms

Conditions

Cerebral Small Vessel Diseases; Stroke, Lacunar; Dementia, Vascular

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Thrombotic Stroke; Ischemic Stroke; Stroke; Brain Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: May 16, 2024
• Study Start: January 13, 2025
• Primary Completion (Estimated): February 15, 2029
• Study Completion (Estimated): February 15, 2029
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

GB (1)