Optical Coherence Tomography (OCT) Trial in Multiple Sclerosis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02907281

Acronym

OCTIMS

Enrollment

414

Registered

2016-09-20

Start date

2012-05-29

Completion date

2017-07-24

Last updated

2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, RRMS

Keywords

Multiple sclerosis,, MS,, Optical coherence tomography, OCT,, RRMS

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.

Interventions

OTHERObservational

Observational

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).
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).
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.

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026