Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369766
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-12
Brief Title:
REtinal Markers In Neuroinflammatory Diseases REMIND
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Retinal Markers in Neuroinflammatory Diseases a Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study including patients with Multiple Sclerosis patients with other neuroinflammatory diseases and healthy controls is to determine the predictive value of retinal markers in predicting disease progression Participants complete a questionnaire and undergo various non-invasive retinal routine clinical examinations
Detailed Description:
Multiple Sclerosis MS is an autoimmune disease of the central nervous system CNS and represents one of the most common neurological disorders affecting young adults worldwide and often leads to significant disability over time While MS typically presents with recurrent neurological symptoms known as relapses most patients also experience progressive neurological deterioration independent of relapses referred to as progression independent of relapse activity PIRA PIRA is a major contributor to long-term disability and represents a significant challenge in the management of MS Early identification of patients at high risk to develop PIRA is crucial for therapeutic decisions and testing treatment efficacy highlighting the urgent need for accurate predictive markers of progression in MS
The primary objective of this longitudinal observational prospective single center study is to investigate the predictive value of various retinal markers in predicting PIRA in MS patients
The study assesses several easily obtained non-invasive retinal measures
Neuroaxonal loss in the retina This serves as a marker of neurodegeneration in the CNS It will be assessed by measuring the volume of the ganglion cell-inner plexiform layer and the thickness of the peripapillary retinal nerve fiber layer using optical coherence tomography OCT
Neuroinflammation in the retina This will be assessed by evaluating thickening of other retinal layers in OCT particularly the inner nuclear layer
Fixation instability of the patients This serves as a marker of global neuronal dysfunction in the CNS It will be measured using Scanner Laser Ophthalmoscopy-OCT
Structural changes of the retinal vessels Particularly the arteriolar and venular diameters will be assessed This serves as a marker of systemic microvascular health and will be measured using static retinal vessel analysis
Functionalperfusional changes of the retinal vessels For a subgroup of patients this will be evaluated using OCT-angiography andor dynamic retinal vessel analysis andor laser speckle flowgraphy These measures provide insights into the functional and perfusional changes of the retinal vessels
As secondary objectives this study comprises
Comparison with other biomarkers of neuroaxonal damage to determine whether the retinal markers are independent andor stronger predictors of PIRA
Comparison with the retinal markers of Healthy Controls and patients with other neuroinflammatory diseases of the CNS to understand the differences in mechanisms of damage
Investigating the associations among the various retinal measures to understand the relationship between neuroaxonal loss functional deficits and vascular changes in MS
Data will be collected at baseline and annually over up to 5 years or for some MS patients up to 10 years to evaluate changes in retinal markers and their correlation with disease progression This comprehensive assessment will provide valuable insights into the utility of retinal markers in predicting PIRA and their relationship with disease severity and progression in MS
The primary objective of this longitudinal observational prospective single center study is to investigate the predictive value of various retinal markers in predicting PIRA in MS patients
The study assesses several easily obtained non-invasive retinal measures
Neuroaxonal loss in the retina This serves as a marker of neurodegeneration in the CNS It will be assessed by measuring the volume of the ganglion cell-inner plexiform layer and the thickness of the peripapillary retinal nerve fiber layer using optical coherence tomography OCT
Neuroinflammation in the retina This will be assessed by evaluating thickening of other retinal layers in OCT particularly the inner nuclear layer
Fixation instability of the patients This serves as a marker of global neuronal dysfunction in the CNS It will be measured using Scanner Laser Ophthalmoscopy-OCT
Structural changes of the retinal vessels Particularly the arteriolar and venular diameters will be assessed This serves as a marker of systemic microvascular health and will be measured using static retinal vessel analysis
Functionalperfusional changes of the retinal vessels For a subgroup of patients this will be evaluated using OCT-angiography andor dynamic retinal vessel analysis andor laser speckle flowgraphy These measures provide insights into the functional and perfusional changes of the retinal vessels
As secondary objectives this study comprises
Comparison with other biomarkers of neuroaxonal damage to determine whether the retinal markers are independent andor stronger predictors of PIRA
Comparison with the retinal markers of Healthy Controls and patients with other neuroinflammatory diseases of the CNS to understand the differences in mechanisms of damage
Investigating the associations among the various retinal measures to understand the relationship between neuroaxonal loss functional deficits and vascular changes in MS
Data will be collected at baseline and annually over up to 5 years or for some MS patients up to 10 years to evaluate changes in retinal markers and their correlation with disease progression This comprehensive assessment will provide valuable insights into the utility of retinal markers in predicting PIRA and their relationship with disease severity and progression in MS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None