Optical Coherence Tomography (OCT) Trial in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— OCTIMS  

Official title:

A 3-year, Multi-center Study to Evaluate Optical Coherence Tomography as an Outcome Measure in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02907281
• Other study ID #: CFTY720D2319
• Secondary ID: 2011-001437-16
• Status: Completed
• Phase: N/A
• First received: September 8, 2016
• Last updated: November 15, 2017
• Start date: May 29, 2012
• Est. completion date: July 24, 2017

Study information

• Verified date: November 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 414
• Est. completion date: July 24, 2017
• Est. primary completion date: July 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Multiple sclerosis patients

• A diagnosis of MS as defined by the 2005 revision to the McDonald criteria with a relapsing-remitting course

• MS disease duration of more than one year (from diagnosis of MS) before study entry

Healthy volunteers

• Matched to MS patients based on age, gender, ethnicity and visual refraction

Related Conditions & MeSH terms

• Multiple Sclerosis
• RRMS
• Sclerosis

Intervention

Other:
• Observational
Observational

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Camperdown	New South Wales
Australia	Novartis Investigative Site	Parkville,	Victoria
Canada	Novartis Investigative Site	Calgary	Alberta
Canada	Novartis Investigative Site	Greenfield Park	Quebec
Czechia	Novartis Investigative Site	Praha 2
Denmark	Novartis Investigative Site	Copenhagen
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Magdeburg
Italy	Novartis Investigative Site	Bari
Italy	Novartis Investigative Site	Cagliari	CA
Italy	Novartis Investigative Site	Genova
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Montichiari
Italy	Novartis Investigative Site	Padova
Italy	Novartis Investigative Site	Roma
Netherlands	Novartis Investigative Site	Amsterdam
Poland	Novartis Investigative Site	Lodz	Lódzkie
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Switzerland	Novartis Investigative Site	Zürich
United Kingdom	Novartis Investigative Site	London
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Iowa City	Iowa
United States	Novartis Investigative Site	Philadelphia	Pennsylvania
United States	Novartis Investigative Site	San Francisco	California
United States	Novartis Investigative Site	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czechia,  Denmark,  Germany,  Italy,  Netherlands,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Retinal Nerve Fiber Layer Thickness (RNFL)	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.	36 months
Secondary	Correlation of change in macular volume with change in brain volume	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.	36 months
Secondary	Assess reproducibility of RNFL thickness on optical coherence tomography	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).	4 weeks
Secondary	Change in macular volume over 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).	36 months
Secondary	Correlation of change in RNFL thickness with change in brain volume	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.	36 months