Optical Coherence Tomography (OCT) Trial in Multiple Sclerosis (OCTIMS)
Status
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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
Trial design
414 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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