A 3-year Multi-center Study to Describe Changes of OCT Parameters Under Treatment With Gilenya®

Phase 4

Completed

• Conditions: Relapsing Remitting Multiple Sclerosis RRMS
• Interventions: Drug: Fingolimod

• Registration Number: NCT01705236
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-13
• Study Start: 2012-08-20
• Study First Submitted QC: 2012-10-11
• Study First Posted: 2012-10-12
• Primary Completion: 2019-02-18
• Study Completion: 2019-02-18
• Status Verified: 2020-02
• Results First Submitted: 2020-02-14
• Results First Submitted QC: 2020-02-14
• Last Update Submitted: 2020-02-14
• Results First Posted: 2020-03-02
• Last Update Posted: 2020-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fingolimod - Longitudinal Assessment	Fingolimod	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Month 36 in Average Retinal Nerve Fiber Layer Thickness (RNFLT)	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 Outcome Measures

Name	Time	Method
Change From Baseline to Month 12, 24 and 36 in Total Macular Volume (TMV)	12, 24 and 36 months	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).
Number of Participants With Adverse Events	36 months	Number of participants with adverse events and specifically macular edema.
Change From Baseline to Month 12 and 24 in Average Retinal Nerve Fiber Layer Thickness (RNFLT)	Baseline, month 12, month 24	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).
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 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.
Change From Baseline to Month 12, 24 and 36 in Ganglion Cell Inner Plexiform (GCIP)	Baseline, month 12, month 24, month 36	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇭 Zuerich, Switzerland