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 Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
87
All subjects received an oral dose of 0.5 mg fingolimod (FTY720) per capsule (hard gelatin capsules) once daily according to local label for the treatment of their MS.
Novartis Investigative Site
Bochum, Germany
Novartis Investigative Site
Bonn, Germany
Novartis Investigative Site
Dresden, Germany
Novartis Investigative Site
Düsseldorf, Germany
Change From Baseline to Month 36 in Average Retinal Nerve Fiber Layer Thickness (RNFLT)
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).
Time frame: Baseline, month 36
Change From Baseline to Month 12 and 24 in Average Retinal Nerve Fiber Layer Thickness (RNFLT)
Change from baseline in average RNFL thickness to months 12 and 24 (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).
Time frame: Baseline, month 12, month 24
Change From Baseline to Month 12, 24 and 36 in Average Quadrant Retinal Nerve Fiber Layer Thickness (RNFLT)
Change from baseline in average quadrant RNFL thickness to months 12, 24 and 36 (or last values in case of missing data) in the Full Analysis Set (FAS). Average quadrant RNFL thickness was the average of valid measurements of the right and left eye and assessed by optical coherence tomography (OCT). Quadrant RNFL thickness were: Nasal-inferior; nasal-superior; temporal-inferior; temporal-superior.
Time frame: Baseline, month 12, month 24, month 36
Change From Baseline to Month 12, 24 and 36 in Total Macular Volume (TMV)
Change from baseline in TMV to months 12, 24 and 36 (or last values in case of missing data) in the Full Analysis Set (FAS).
Time frame: 12, 24 and 36 months
Change From Baseline to Month 12, 24 and 36 in Ganglion Cell Inner Plexiform (GCIP)
Change from baseline in GCIP to months 12, 24 and 36 (or last values in case of missing data) in the Full Analysis Set (FAS). The change in Ganglion cell layer thickness (GCLT) had been defined as secondary endpoint in the protocol, but OCT measured the GCIP instead. This was done because both layers were not clearly separable by OCT. GCIP was calculated as mean of the inner sectors (nasal, superior, temporal, and inferior) and declared as usual parameter instead. This change was introduced prior to data base lock, but the derivation of GCIP was corrected after data base lock.
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Novartis Investigative Site
Hanover, Germany
Novartis Investigative Site
Heidelberg, Germany
Novartis Investigative Site
Leipzig, Germany
Novartis Investigative Site
Rostock, Germany
Novartis Investigative Site
Ulm, Germany
Novartis Investigative Site
Zurich, Switzerland
Time frame: Baseline, month 12, month 24, month 36
Number of Participants With Adverse Events
Number of participants with adverse events and specifically macular edema.
Time frame: 36 months