Optical Coherence Tomography (OCT) Trial in Multiple Sclerosis

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

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.

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