A 3-year Multi-center Study to Describe the Long Term Changes of Optical Coherence Tomography (OCT) Parameters in Patients Under Treatment With Gilenya®
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- Change From Baseline to Month 36 in Average Retinal Nerve Fiber Layer Thickness (RNFLT)
Study Overview
Brief Summary
This was a 3-year, prospective, multi-center, open-label study to describe the long term changes of optical coherence tomography (OCT) parameters in RRMS patients under treatment with Fingolimod. It was designed to longitudinally study the degeneration of retinal axons by measuring change in RNFL thickness by latest OCT-technology.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Fingolimod - Longitudinal Assessment
No study drug was provided. Fingolimod was to be prescribed according to local label. The decision to prescribe fingolimod had to be made independent of this study.
Intervention: Fingolimod (Drug)
Outcomes
Primary Outcomes
Change From Baseline to Month 36 in Average Retinal Nerve Fiber Layer Thickness (RNFLT)
Time Frame: Baseline, month 36
The primary endpoint was the change, i.e. the absolute difference, in average RNFL thickness from baseline to month 36 (or last values in case of missing data) in the Full Analysis Set (FAS). Average RNFL thickness was the average of valid measurements of the right and left eye and assessed by optical coherence tomography (OCT).
Secondary Outcomes
- Change From Baseline to Month 12, 24 and 36 in Total Macular Volume (TMV)(12, 24 and 36 months)
- Number of Participants With Adverse Events(36 months)
- Change From Baseline to Month 12 and 24 in Average Retinal Nerve Fiber Layer Thickness (RNFLT)(Baseline, month 12, month 24)
- Change From Baseline to Month 12, 24 and 36 in Average Quadrant Retinal Nerve Fiber Layer Thickness (RNFLT)(Baseline, month 12, month 24, month 36)
- Change From Baseline to Month 12, 24 and 36 in Ganglion Cell Inner Plexiform (GCIP)(Baseline, month 12, month 24, month 36)