Optical Coherence Tomography (OCT) Trial in Multiple Sclerosis

Study Overview
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Brief Summary
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This is a 3-year, pharmacologically non-interventional study to evaluate OCT as an outcome measure in patients with relapsing remitting multiple sclerosis (RRMS). Approximately 350 RRMS patients, either untreated or treated with an approved MS disease-modifying therapy and approximately 70 reference subjects without ophthalmologic or neurologic disease are enrolled. No study medications are provided. Patients on disease-modifying therapy are treated according to the local prescribing information. For each MS patient and each reference subject, the study consists of Screening (up to 1 month), Baseline, and a 36-month longitudinal data collection phase. Eligibility will be confirmed during Screening.

Official Title
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A 3-year, Multi-center Study to Evaluate Optical Coherence Tomography as an Outcome Measure in Patients With Multiple Sclerosis

Conditions
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Multiple Sclerosis, RRMS

Intervention / Treatment
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* Other: Observational


Participation Criteria
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Eligibility Criteria
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Multiple sclerosis patients A diagnosis of MS as defined by the 2005 revision to the McDonald criteria with a relapsing-remitting course MS disease duration of more than one year (from diagnosis of MS) before study entry Healthy volunteers - Matched to MS patients based on age, gender, ethnicity and visual refraction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multiple sclerosis patients<br>Multiple sclerosis patients | Other: Observational<br>* Observational<br>|
| Healthy volunteers<br>Healthy volunteers | Other: Observational<br>* Observational<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Retinal Nerve Fiber Layer Thickness (RNFL) | evaluate change in RNFL thickness in relapsing remitting multiple sclerosis (RRMS) patients followed for up to 36 months compared to a group of reference subjects (without neurologic or ophthalmic disease) to determine whether the technology is sufficiently sensitive to disease and to change over time. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of change in macular volume with change in brain volume | To evaluate the correlation of change in macular volume with change in brain volume as measured by MRI in RRMS patients followed for up to 36 months. | 36 months | 
| Assess reproducibility of RNFL thickness on optical coherence tomography | To evaluate short-team reproducibility of the RNFL thickness measure at study start by test/re-test estimation after a 4-week interval in RRMS patients and reference subjects (without neurologic or ophthalmic disease). | 4 weeks | 
| Change in macular volume over 36 months | To evaluate change in macular volume over 36 months in RRMS patients compared to a group of reference subjects (without neurologic or ophthalmic disease). | 36 months | 
| Correlation of change in RNFL thickness with change in brain volume | To evaluate the correlation of change in RNFL thickness with change in brain volume as measured by magnetic resonance imaging (MRI) in RRMS patients followed for up to 36 months. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis,, MS,, Optical coherence tomography, OCT,, RRMS