Optical Coherence Tomography (OCT) Trial in Multiple Sclerosis
NCT ID: NCT02907281
Last Updated: 2017-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
414 participants
OBSERVATIONAL
2012-05-29
2017-07-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Multiple sclerosis patients
Multiple sclerosis patients
Observational
Observational
Healthy volunteers
Healthy volunteers
Observational
Observational
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Observational
Observational
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
San Francisco, California, United States
Novartis Investigative Site
Torrance, California, United States
Novartis Investigative Site
Iowa City, Iowa, United States
Novartis Investigative Site
Baltimore, Maryland, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, United States
Novartis Investigative Site
Camperdown, New South Wales, Australia
Novartis Investigative Site
Parkville, Victoria, Australia
Novartis Investigative Site
Calgary, Alberta, Canada
Novartis Investigative Site
Greenfield Park, Quebec, Canada
Novartis Investigative Site
Prague, , Czechia
Novartis Investigative Site
Copenhagen, , Denmark
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Magdeburg, , Germany
Novartis Investigative Site
Cagliari, CA, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Bari, , Italy
Novartis Investigative Site
Genova, , Italy
Novartis Investigative Site
Montichiari, , Italy
Novartis Investigative Site
Padua, , Italy
Novartis Investigative Site
Roma, , Italy
Novartis Investigative Site
Amsterdam, , Netherlands
Novartis Investigative Site
Lodz, Lódzkie, Poland
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Zurich, , Switzerland
Novartis Investigative Site
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-001437-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CFTY720D2319
Identifier Type: -
Identifier Source: org_study_id