Optical Coherence Tomography (OCT) Trial in Multiple Sclerosis

Completed

• Conditions: RRMS; Multiple Sclerosis
• Interventions: Other: Observational

• Registration Number: NCT02907281
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-29
• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-15
• Study First Posted: 2016-09-20
• Primary Completion: 2017-07-24
• Study Completion: 2017-07-24
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-15
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 414

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Observational	Healthy volunteers
Multiple sclerosis patients	Observational	Multiple sclerosis patients

Primary Outcome Measures

Name	Time	Method
Change in Retinal Nerve Fiber Layer Thickness (RNFL)	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 Outcome Measures

Name	Time	Method
Correlation of change in macular volume with change in brain volume	36 months	To evaluate the correlation of change in macular volume with change in brain volume as measured by MRI in RRMS patients followed for up to 36 months.
Assess reproducibility of RNFL thickness on optical coherence tomography	4 weeks	To evaluate short-team reproducibility of the RNFL thickness measure at study start by test/re-test estimation after a 4-week interval in RRMS patients and reference subjects (without neurologic or ophthalmic disease).
Correlation of change in RNFL thickness with change in brain volume	36 months	To evaluate the correlation of change in RNFL thickness with change in brain volume as measured by magnetic resonance imaging (MRI) in RRMS patients followed for up to 36 months.
Change in macular volume over 36 months	36 months	To evaluate change in macular volume over 36 months in RRMS patients compared to a group of reference subjects (without neurologic or ophthalmic disease).

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 London, United Kingdom