Clinical trial NCT02907281: Optical Coherence Tomography (OCT) Trial in Multiple Sclerosis
Official title: A 3-year, Multi-center Study to Evaluate Optical Coherence Tomography as an Outcome Measure in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
RRMS
Keywords: Multiple sclerosis,
MS,
Optical coherence tomography
OCT,
RRMS
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-09-20
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple Sclerosis patients and healthy volunteers

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.


Eligibility 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

Primary outcomes:
measure: Change in Retinal Nerve Fiber Layer Thickness (RNFL)
timeFrame: 36 months
Secondary outcomes:
measure: Correlation of change in macular volume with change in brain volume
timeFrame: 36 months
measure: Assess reproducibility of RNFL thickness on optical coherence tomography
timeFrame: 4 weeks
measure: Change in macular volume over 36 months
timeFrame: 36 months
measure: Correlation of change in RNFL thickness with change in brain volume
timeFrame: 36 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Novartis Investigative Site
state: California
city: Torrance
country: United States
facility: Novartis Investigative Site
state: California
city: Iowa City
country: United States
facility: Novartis Investigative Site
state: Iowa
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Camperdown
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Parkville,
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Calgary
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Greenfield Park
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Praha 2
country: Czechia
facility: Novartis Investigative Site
city: Copenhagen
country: Denmark
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Cagliari
country: Italy
facility: Novartis Investigative Site
state: CA
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Bari
country: Italy
facility: Novartis Investigative Site
city: Genova
country: Italy
facility: Novartis Investigative Site
city: Montichiari
country: Italy
facility: Novartis Investigative Site
city: Padova
country: Italy
facility: Novartis Investigative Site
city: Roma
country: Italy
facility: Novartis Investigative Site
city: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
state: Lódzkie
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Zürich
country: Switzerland
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: