Multiple SclerosisNCT06369766
REtinal Markers In Neuroinflammatory Diseases ("REMIND")
An observational study of Multiple Sclerosis and Neuroinflammatory Diseases, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Neuroinflammatory Diseases
- What is being tested?
- Optical coherence tomography (OCT), Static retinal vessel analyzer and Dynamic retinal vessel analyzer
- How many people
- 500 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Jan 2024to Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Multiple Sclerosis and the other neuroinflammatory diseases are recruited in the Multiple Sclerosis and Neuroimmunology center of the Department of Neurology at the University Hospital Basel in Basel. These patients with Multiple Sclerosis are participants of the ongoing observational Swiss Multiple Sclerosis Cohort Study. Healthy Controls are recruited from an older healthy control-cohort, which were matched to the Multiple Sclerosis patients and underwent Optical Coherence Tomography in 2016/2017. Further Healthy Controls are recruited bycontacting volunteers that participated in previous studies and agreed to be contacted again for new studies and by public announcements.
Who may be able to join
- All groups:
- Age >18 years old
- Patients with Multiple Sclerosis:
- Diagnosis of Multiple Sclerosis, according to the last revisions of the McDonald Criteria (2017)
- Patients with other neuroinflammatory diseases:
- Diagnosis of Neuromyelitis optica spectrum disorder or Myelin oligodendrocyte glycoprotein antibody disease or other neuroinflammatory disorders other than Multiple Sclerosis
Who cannot join
- All groups:
- Inability to undergo Optical Coherence Tomography (OCT) and/or retinal vessel imaging (e.g. severe nystagmus that prevents eye fixation on both eyes)
- Presence of any ocular pathology that may interfere with the validity of the OCT/retinal vessel analysis (cataracts, glaucoma, history of refractive defects >6 D etc.).
- Pregnancy and Lactation
- Healthy Controls
- History of other neurological conditions: participants with a history of other significant neurological conditions that might interfere with the assessment or interpretation of the signs and symptoms will be excluded (e.g. confirmed Stroke, Acute disseminated encephalomyelitis, Chronic inflammatory Demyelinating Disease, Polyneuropathy, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel, Department of Neurology
Basel, 4031
Athina Papadopoulou, PD Dr. med., +41 61 32 85704, Athina.Papadopoulou@usb.ch
Athina Papadopoulou, PD Dr. med.
About this study
Official title: Retinal Markers in Neuroinflammatory Diseases: a Prospective Observational Study
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.
Read the 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.
- Functional/perfusional changes of the retinal vessels: For a subgroup of patients, this will be evaluated using OCT-angiography, and/or dynamic retinal vessel analysis, and/or 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 and/or 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.
- Conditions
- Multiple Sclerosis, Neuroinflammatory Diseases
- Being tested
- Optical coherence tomography (OCT), Static retinal vessel analyzer, Dynamic retinal vessel analyzer, Laser speckle flowgraphy system, Questionnaire
- Keywords
- Retinal Markers, OCT, Disease Progression, Progression Independent of Relapse Activity (PIRA)
- Medical subject headings
- Multiple Sclerosis, Neuroinflammatory Diseases, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography (OCT)Diagnostic test
OCT is used to measure:
- peripapillary retinal nerve fiber layer (mean thickness in μm)
- ganglion cell-inner plexiform layer (volume in mm^3 and mean thickness in μm)
- other retinal layers (inner nuclear layer, outer plexiform layer, outer nerve layer; volumes in mm^3 and mean thickness in μm).
The "scanner laser ophthalmoscopy"-function of the OCT device is used to continuously record the exact location of each participant's fixation point in relation to their fovea and thereby allows the assessment of the fixation instability.
In a subgroup of participants, the "angiography"-module of the OCT device is used to image the retinal blood flow and thereby allows to measure the vascular area density of the superficial retinal capillary plexus and deep retinal capillary plexus.
Static retinal vessel analyzerDiagnostic test
Static retinal vessel analyzer is used to determine:
- central retinal arteriolar diameter equivalents (in μm)
- central retinal venular diameter equivalents (in μm)
- arteriolar-to-venular diameter ratio
Dynamic retinal vessel analyzerDiagnostic test
In a subgroup of participants, the dynamic retinal vessel analyzer is used to determine the arteriolar ficker light-induced dilatation, venular ficker light-induced dilatation, and Arteriolar constriction, measured in % dilatation in comparison to baseline.
Laser speckle flowgraphy systemDiagnostic test
In a subgroup of participants, the laser speckle flowgraphy system is used to measure the relative ocular blood flow as expressed in arbitary units of Mean Blur Rate.
QuestionnaireOther
All study participants will be asked to fill in a questionnaire with various questions regarding existing eye diseases, other diseases (including vascular diseases/risk factors), and daily physical activity that could influence the results of the retinal examinations. Physical activity will be assessed using an adapted form of the standardized Global Physical Activity Questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Healthy control subjects without neurological diseases Receives: Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Static retinal vessel analyzer; Diagnostic Test: Dynamic retinal vessel analyzer; Diagnostic Test: Laser speckle flowgraphy system; Other: Questionnaire | |
| Patients with Multiple Sclerosis | Not described Receives: Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Static retinal vessel analyzer; Diagnostic Test: Dynamic retinal vessel analyzer; Diagnostic Test: Laser speckle flowgraphy system; Other: Questionnaire | |
| Patients with other neuroinflammatory diseases of the CNS | Not described Receives: Diagnostic Test: Optical coherence tomography (OCT); Diagnostic Test: Static retinal vessel analyzer; Diagnostic Test: Dynamic retinal vessel analyzer; Diagnostic Test: Laser speckle flowgraphy system; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of Progression Independent of Relapse Activity (PIRA)
The group of "Multiple Sclerosis patients" undergo a detailed neurological interview and examination for the calculation of the Expanded Disability Status Scale (EDSS) at each clinical visit every 6 or 12 months. The EDSS worsening is used to define PIRA retrospectively (increase of ≥1.5 points if baseline EDSS was 0 points, increase of ≥1.0 points if baseline EDSS was 1-5.5 points or increase of ≥0.5 point if baseline EDSS was >5.5 points), with no relapse between the reference- event- and confirmation score visits. Relapse is defined as objectively observed signs typical of an acute CNS inflammatory demyelinating event, with duration of at least 24hours in the absence of fever or infection, separated from the last relapse by ≥30 days. The occurence of PIRA (yes/no) is assessed at the end of the follow-up period of the different retinal markers (5 years or for a subgroup up to 10 years after baseline).
Measured: 5 Years (or for a subgroup up to 10 years) after baseline
Neuroaxonal loss in the retina (as marker of neurodegeneration in the CNS)
To determine the neuroaxonal loss in the retina, the thickness of the peripapillary retinal nerve fiber layer and the volume of the ganglion cell-inner plexiform layer are assessed by optical coherence tomography (OCT).
Measured: Baseline and once every year over up to 5 years
Neuroinflammation in the retina
To determine the neuroinflammation in the retina, the thickening of the outer plexiform layer, outer nerve layer and ,in particular, of the inner nuclear layer are assessed by OCT.
Measured: Baseline and once every year over up to 5 years
Fixation instability (as marker of global neuronal dysfunction in the CNS)
To determine the fixation instability, visual fixation measurements are recorded via the "Scanner Laser Ophthalmoscopy"-function of the OCT device (as described by Mallery et al., 2018; PMID: 29340646).
Measured: Baseline and once every year over up to 5 years
Structural changes of the retinal vessels (as marker of systemic microvascular health)
To determine structural changes of the retinal vessels, the retinal arterior and venular diameters are measured by static retinal vessel analysis.
Measured: Baseline and once every year over up to 5 years
(For a subgroup of participants) Functional/perfusional changes of the retinal vessels
To determine the functional/perfusional changes of the retinal vessels, a subgroup of participants (patients= 100, Healthy Controls= 50) undergoes additional examinations:
- OCT-Angiography: measurement of retinal perfusion
- Dynamic Retinal vessel analysis: measurement examining the motility and function of the retinal vessels
- Laser Speckle Flowgraphy: measurement of ocular perfusion
Measured: Baseline and once every year over up to 5 years
Secondary outcomes (3)
Relative value of retinal markers for the prediction of PIRA compared to or combined with other biomarkers of neuroaxonal damage
Data regarding other biomarkers (serum neurofilament light chain and brain volume on magnet resonance imaging) that are already available within the clinical routine and/or the SMSC study are used to assess the relative value of the retinal markers described above under primary outcome measures 2-6 in predicting PIRA, both independently or in combination with these other biomarkers.
Measured: Baseline and once every year over up to 5 years
Comparison of the examined retinal markers of Multiple Sclerosis patients with Healthy Controls and with patients with other neuroinflammatory diseases of the CNS
Examined retinal markers are compared between the different groups to understand the relationship among the different measures independently of disease.
Measured: Baseline and once every year over up to 5 years
The relationship between neuroaxonal loss, functional deficits and vascular changes in Multiple Sclerosis
Investigation of the associations among the examined retinal measures to understand the relationship between neuroaxonal loss, functional deficits and vascular changes in Multiple Sclerosis.
Measured: Baseline and once every year over up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start31 Jan 2024
- Primary completionDec 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel
- Responsible party
- Sponsor
- Investigators
- Athina Papadopoulou, PD Dr. med., Principal investigator, University Hospital Basel, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369766
- Sponsor's protocol ID
- 2023-02144; ko23Papadopoulou4
- Other IDs
- 2023
- Status last verified
- May 2025
- First submitted
- 12 Apr 2024
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Markers in Neuroinflammatory Diseases: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06369766
- Acronym / sponsor ID
- 2023-02144; ko23Papadopoulou4
- Conditions
- Multiple Sclerosis, Neuroinflammatory Diseases
- Keywords
- Retinal Markers, OCT, Disease Progression, Progression Independent of Relapse Activity (PIRA)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Basel
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Functional/perfusional changes of the retinal vessels: For a subgroup of patients, this will be evaluated using OCT-angiography, and/or dynamic retinal vessel analysis, and/or 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 and/or 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Diagnostic Test: Optical coherence tomography (OCT), Diagnostic Test: Static retinal vessel analyzer, Diagnostic Test: Dynamic retinal vessel analyzer, Diagnostic Test: Laser speckle flowgraphy system, Other: QuestionnaireHealthy control subjects without neurological diseases |
| Patients with Multiple Sclerosis | – | Diagnostic Test: Optical coherence tomography (OCT), Diagnostic Test: Static retinal vessel analyzer, Diagnostic Test: Dynamic retinal vessel analyzer, Diagnostic Test: Laser speckle flowgraphy system, Other: Questionnaire |
| Patients with other neuroinflammatory diseases of the CNS | – | Diagnostic Test: Optical coherence tomography (OCT), Diagnostic Test: Static retinal vessel analyzer, Diagnostic Test: Dynamic retinal vessel analyzer, Diagnostic Test: Laser speckle flowgraphy system, Other: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Multiple Sclerosis and the other neuroinflammatory diseases are recruited in the Multiple Sclerosis and Neuroimmunology center of the Department of Neurology at the University Hospital Basel in Basel. These patients with Multiple Sclerosis are participants of the ongoing observational Swiss Multiple Sclerosis Cohort Study. Healthy Controls are recruited from an older healthy control-cohort, which were matched to the Multiple Sclerosis patients and underwent Optical Coherence Tomography in 2016/2017. Further Healthy Controls are recruited bycontacting volunteers that participated in previous studies and agreed to be contacted again for new studies and by public announcements.
Key inclusion criteria (6 listed)
- All groups:
- Patients with Multiple Sclerosis:
- Patients with other neuroinflammatory diseases:
Key exclusion criteria (6 listed)
- All groups:
- Healthy Controls
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical coherence tomography (OCT)OCT is used to measure: * peripapillary retinal nerve fiber layer (mean thickness in μm) * ganglion cell-inner plexiform layer (volume in mm^3 and mean thickness in μm) * other retinal layers (inner nuclear layer, outer plexiform layer, outer nerve layer; volumes in mm^3 and mean thickness in μm). The "scanner laser ophthalmoscopy"-function of the OCT device is used to continuously record the exact location of each participant's fixation point in relation to their fovea and thereby allows the assessment of the fixation instability. In a subgroup of participants, the "angiography"-module of the OCT device is used to image the retinal blood flow and thereby allows to measure the vascular area density of the superficial retinal capillary plexus and deep retinal capillary plexus. | Diagnostic test | Healthy Controls, Patients with Multiple Sclerosis, Patients with other neuroinflammatory diseases of the CNS |
| Static retinal vessel analyzerStatic retinal vessel analyzer is used to determine: * central retinal arteriolar diameter equivalents (in μm) * central retinal venular diameter equivalents (in μm) * arteriolar-to-venular diameter ratio | Diagnostic test | Healthy Controls, Patients with Multiple Sclerosis, Patients with other neuroinflammatory diseases of the CNS |
| Dynamic retinal vessel analyzerIn a subgroup of participants, the dynamic retinal vessel analyzer is used to determine the arteriolar ficker light-induced dilatation, venular ficker light-induced dilatation, and Arteriolar constriction, measured in % dilatation in comparison to baseline. | Diagnostic test | Healthy Controls, Patients with Multiple Sclerosis, Patients with other neuroinflammatory diseases of the CNS |
| Laser speckle flowgraphy systemIn a subgroup of participants, the laser speckle flowgraphy system is used to measure the relative ocular blood flow as expressed in arbitary units of Mean Blur Rate. | Diagnostic test | Healthy Controls, Patients with Multiple Sclerosis, Patients with other neuroinflammatory diseases of the CNS |
| QuestionnaireAll study participants will be asked to fill in a questionnaire with various questions regarding existing eye diseases, other diseases (including vascular diseases/risk factors), and daily physical activity that could influence the results of the retinal examinations. Physical activity will be assessed using an adapted form of the standardized Global Physical Activity Questionnaire. | Other | Healthy Controls, Patients with Multiple Sclerosis, Patients with other neuroinflammatory diseases of the CNS |
Primary outcome
Occurence of Progression Independent of Relapse Activity (PIRA)
Time frame: 5 Years (or for a subgroup up to 10 years) after baseline
The group of "Multiple Sclerosis patients" undergo a detailed neurological interview and examination for the calculation of the Expanded Disability Status Scale (EDSS) at each clinical visit every 6 or 12 months. The EDSS worsening is used to define PIRA retrospectively (increase of ≥1.5 points if baseline EDSS was 0 points, increase of ≥1.0 points if baseline EDSS was 1-5.5 points or increase of ≥0.5 point if baseline EDSS was >5.5 points), with no relapse between the reference- event- and confirmation score visits. Relapse is defined as objectively observed signs typical of an acute CNS inflammatory demyelinating event, with duration of at least 24hours in the absence of fever or infection, separated from the last relapse by ≥30 days. The occurence of PIRA (yes/no) is assessed at the end of the follow-up period of the different retinal markers (5 years or for a subgroup up to 10 years after baseline).
Neuroaxonal loss in the retina (as marker of neurodegeneration in the CNS)
Time frame: Baseline and once every year over up to 5 years
To determine the neuroaxonal loss in the retina, the thickness of the peripapillary retinal nerve fiber layer and the volume of the ganglion cell-inner plexiform layer are assessed by optical coherence tomography (OCT).
Neuroinflammation in the retina
Time frame: Baseline and once every year over up to 5 years
To determine the neuroinflammation in the retina, the thickening of the outer plexiform layer, outer nerve layer and ,in particular, of the inner nuclear layer are assessed by OCT.
Fixation instability (as marker of global neuronal dysfunction in the CNS)
Time frame: Baseline and once every year over up to 5 years
To determine the fixation instability, visual fixation measurements are recorded via the "Scanner Laser Ophthalmoscopy"-function of the OCT device (as described by Mallery et al., 2018; PMID: 29340646).
Structural changes of the retinal vessels (as marker of systemic microvascular health)
Time frame: Baseline and once every year over up to 5 years
To determine structural changes of the retinal vessels, the retinal arterior and venular diameters are measured by static retinal vessel analysis.
(For a subgroup of participants) Functional/perfusional changes of the retinal vessels
Time frame: Baseline and once every year over up to 5 years
To determine the functional/perfusional changes of the retinal vessels, a subgroup of participants (patients= 100, Healthy Controls= 50) undergoes additional examinations: * OCT-Angiography: measurement of retinal perfusion * Dynamic Retinal vessel analysis: measurement examining the motility and function of the retinal vessels * Laser Speckle Flowgraphy: measurement of ocular perfusion
3 secondary outcomes
Relative value of retinal markers for the prediction of PIRA compared to or combined with other biomarkers of neuroaxonal damage
Time frame: Baseline and once every year over up to 5 years
Comparison of the examined retinal markers of Multiple Sclerosis patients with Healthy Controls and with patients with other neuroinflammatory diseases of the CNS
Time frame: Baseline and once every year over up to 5 years
The relationship between neuroaxonal loss, functional deficits and vascular changes in Multiple Sclerosis
Time frame: Baseline and once every year over up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Athina Papadopoulou, PD Dr. med. principal investigator
University Hospital Basel, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Neuroinflammatory Diseases, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Athina Papadopoulou, PD Dr. med. (+41 61 32 85704, Athina.Papadopoulou@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of Progression Independent of Relapse Activity (PIRA) (time frame: 5 Years (or for a subgroup up to 10 years) after baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.