MSFrontier

OCTIMS

A 3-year, Multi-center Study to Evaluate Optical Coherence Tomography as an Outcome Measure in Patients With Multiple Sclerosis
CompletedPhase 3Relapsing MSNCT029072812011-001437-16

What it found

No result found

We found no results in the registry or in papers.

This trial finished 9 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

What it measured

Main measures

  • Change in Retinal Nerve Fiber Layer Thickness (RNFL)

    36 months

    Retina scans (OCT)

  • The primary objective of the study is to evaluate the change in RNFL thickness in MS patients followed for up to 36 months compared to a group of reference subjects (without ophthalmic

    Retina scans (OCT)

Other measures (4)

  • Correlation of change in macular volume with change in brain volume

    36 months

    MRI lesionsBrain volume loss

  • Assess reproducibility of RNFL thickness on optical coherence tomography

    4 weeks

    Retina scans (OCT)

  • Change in macular volume over 36 months

    36 months

  • Correlation of change in RNFL thickness with change in brain volume

    36 months

    MRI lesionsBrain volume lossRetina scans (OCT)

Who could take part

Relapsing MS · 18 to 65

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    Related trials

    History

      1. Started

        May 2012

      2. Main results due

        Jul 2017

      3. Finished

        Jul 2017

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