Optical Coherence Tomography (OCT) Trial in Multiple Sclerosis
NCT02907281 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 414
Last updated 2017-11-17
Summary
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.
Conditions
- Multiple Sclerosis
- RRMS
Interventions
- OTHER
-
Observational
Observational
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-05-29
- Primary Completion
- 2017-07-24
- Completion
- 2017-07-24
Countries
- United States
- Australia
- Canada
- Czechia
- Denmark
- Germany
- Italy
- Netherlands
- Poland
- Spain
- Switzerland
- United Kingdom
Study Locations
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