Optical Coherence Tomography (OCT) Trial in Multiple Sclerosis

Status:	Completed
Conditions:	Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:	Neurology, Other
Healthy:	No
Age Range:	18 - 65
Updated:	11/18/2017
Start Date:	May 29, 2012
End Date:	July 24, 2017

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

We found this trial at

sites

Novartis

Baltimore, Maryland 21287

from

Baltimore, MD