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Completed

NCT Number: NCT02907281

Optical Coherence Tomography (OCT) Trial in 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases RRMS

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational

Other

Observational

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: OCTIMS

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Sep 20, 2016
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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