A 3-year, Multi-center Study to Evaluate Optical Coherence Tomography as an Outcome Measure in Patients With Multiple Sclerosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 414
- Locations
- 1
- Primary Endpoint
- Change in Retinal Nerve Fiber Layer Thickness (RNFL)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Retinal Nerve Fiber Layer Thickness (RNFL)
Time Frame: 36 months
evaluate change in RNFL thickness in relapsing remitting multiple sclerosis (RRMS) patients followed for up to 36 months compared to a group of reference subjects (without neurologic or ophthalmic disease) to determine whether the technology is sufficiently sensitive to disease and to change over time.
Secondary Outcomes
- Correlation of change in macular volume with change in brain volume(36 months)
- Assess reproducibility of RNFL thickness on optical coherence tomography(4 weeks)
- Correlation of change in RNFL thickness with change in brain volume(36 months)
- Change in macular volume over 36 months(36 months)