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.
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
6
sites
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