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.
Study Type
OBSERVATIONAL
Enrollment
414
Observational
Novartis Investigative Site
San Francisco, California, United States
Novartis Investigative Site
Torrance, California, United States
Novartis Investigative Site
Iowa City, Iowa, United States
Novartis Investigative Site
Baltimore, Maryland, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, United States
Novartis Investigative Site
Camperdown, New South Wales, Australia
Novartis Investigative Site
Parkville, Victoria, Australia
Novartis Investigative Site
Calgary, Alberta, Canada
Novartis Investigative Site
Greenfield Park, Quebec, Canada
Novartis Investigative Site
Prague, Czechia
...and 18 more locations
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.
Time frame: 36 months
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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 36 months
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