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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02907281




Registration number
NCT02907281
Ethics application status
Date submitted
8/09/2016
Date registered
20/09/2016
Date last updated
17/11/2017

Titles & IDs
Public title
Optical Coherence Tomography (OCT) Trial in Multiple Sclerosis
Scientific title
A 3-year, Multi-center Study to Evaluate Optical Coherence Tomography as an Outcome Measure in Patients With Multiple Sclerosis
Secondary ID [1] 0 0
2011-001437-16
Secondary ID [2] 0 0
CFTY720D2319
Universal Trial Number (UTN)
Trial acronym
OCTIMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
RRMS 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Observational

Multiple sclerosis patients - Multiple sclerosis patients

Healthy volunteers - Healthy volunteers


Other interventions: Observational
Observational

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Retinal Nerve Fiber Layer Thickness (RNFL) - 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.
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
Correlation of change in macular volume with change in brain volume - 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.
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
Assess reproducibility of RNFL thickness on optical coherence tomography - 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).
Timepoint [2] 0 0
4 weeks
Secondary outcome [3] 0 0
Change in macular volume over 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).
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
Correlation of change in RNFL thickness with change in brain volume - 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.
Timepoint [4] 0 0
36 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Camperdown
Recruitment hospital [2] 0 0
Novartis Investigative Site - Parkville,
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3065 - Parkville,
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
Canada
State/province [5] 0 0
Alberta
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
Czechia
State/province [7] 0 0
Praha 2
Country [8] 0 0
Denmark
State/province [8] 0 0
Copenhagen
Country [9] 0 0
Germany
State/province [9] 0 0
Berlin
Country [10] 0 0
Germany
State/province [10] 0 0
Magdeburg
Country [11] 0 0
Italy
State/province [11] 0 0
CA
Country [12] 0 0
Italy
State/province [12] 0 0
MI
Country [13] 0 0
Italy
State/province [13] 0 0
Bari
Country [14] 0 0
Italy
State/province [14] 0 0
Genova
Country [15] 0 0
Italy
State/province [15] 0 0
Montichiari
Country [16] 0 0
Italy
State/province [16] 0 0
Padova
Country [17] 0 0
Italy
State/province [17] 0 0
Roma
Country [18] 0 0
Netherlands
State/province [18] 0 0
Amsterdam
Country [19] 0 0
Poland
State/province [19] 0 0
Lódzkie
Country [20] 0 0
Spain
State/province [20] 0 0
Catalunya
Country [21] 0 0
Spain
State/province [21] 0 0
Cataluña
Country [22] 0 0
Spain
State/province [22] 0 0
Comunidad Valenciana
Country [23] 0 0
Spain
State/province [23] 0 0
Madrid
Country [24] 0 0
Switzerland
State/province [24] 0 0
Zürich
Country [25] 0 0
United Kingdom
State/province [25] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02907281
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications