NCT02907281

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 414 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
OTHER	Observational	Observational

Timeline

• Start date: 2012-05-29
• Primary completion: 2017-07-24
• Completion: 2017-07-24
• First posted: 2016-09-20
• Last updated: 2017-11-17

Locations

28 sites across 12 countries: United States, Australia, Canada, Czechia, Denmark, Germany, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom