Optical Coherence Tomography (OCT) Trial in Multiple Sclerosis (OCTIMS)

November 15, 2017 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

414

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Novartis Investigative Site
    • Victoria
      • Parkville,, Victoria, Australia, 3065
        • Novartis Investigative Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z1
        • Novartis Investigative Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2J2
        • Novartis Investigative Site
  • Czechia
      • Praha 2, Czechia, 128 08
        • Novartis Investigative Site
  • Denmark
      • Copenhagen, Denmark, DK-2100
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 10117
        • Novartis Investigative Site
      • Magdeburg, Germany, 39120
        • Novartis Investigative Site
  • Italy
      • Bari, Italy, 70124
        • Novartis Investigative Site
      • Genova, Italy, 16132
        • Novartis Investigative Site
      • Montichiari, Italy, 25018
        • Novartis Investigative Site
      • Padova, Italy, 35128
        • Novartis Investigative Site
      • Roma, Italy, 189
        • Novartis Investigative Site
    • CA
      • Cagliari, CA, Italy, 09126
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20132
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands, 1081
        • Novartis Investigative Site
  • Poland
    • Lódzkie
      • Lodz, Lódzkie, Poland, 90-153
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28040
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Novartis Investigative Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 8036
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46026
        • Novartis Investigative Site
  • Switzerland
      • Zürich, Switzerland, 8091
        • Novartis Investigative Site
  • United Kingdom
      • London, United Kingdom, EC1V 2PD
        • Novartis Investigative Site
  • United States
    • California
      • San Francisco, California, United States, 94143-0359
        • Novartis Investigative Site
      • Torrance, California, United States, 90509-2004
        • Novartis Investigative Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Novartis Investigative Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Novartis Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Multiple Sclerosis patients and healthy volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy volunteers
Other: Observational
Observational
Multiple sclerosis patients
Other: Observational
Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Retinal Nerve Fiber Layer Thickness (RNFL)
Time Frame: 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.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of change in macular volume with change in brain volume
Time Frame: 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.
36 months
Assess reproducibility of RNFL thickness on optical coherence tomography
Time Frame: 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).
4 weeks
Change in macular volume over 36 months
Time Frame: 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
Correlation of change in RNFL thickness with change in brain volume
Time Frame: 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.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 29, 2012

Primary Completion (ACTUAL)

July 24, 2017

Study Completion (ACTUAL)

July 24, 2017

Study Registration Dates

First Submitted

September 8, 2016

First Submitted That Met QC Criteria

September 15, 2016

First Posted (ESTIMATE)

September 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 15, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFTY720D2319
  • 2011-001437-16 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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