Studying the Effects of Copaxone on Retinal Health Using Optical Tomography Over 24 Months
NCT ID: NCT02017808
Last Updated: 2014-12-03
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
100 participants
OBSERVATIONAL
2014-02-28
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The secondary objective of this study is to investigate the effect of GA on total macular volume (TMV) on OCT in patients with RRMS over 24 months. We will also explore how the 24-month changes of RNFLT and TMV on OCT relate to progression of disability, as measured by Expanded Disability Status Scale (EDSS).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Copaxone
Patients with multiple sclerosis who are currently prescribed glatiramer acitate (Copaxone)
No interventions assigned to this group
OCT
Healthy controls
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Starting GA monotherapy (20mg/day sc) at the time of the OCT scan
* Having baseline clinical OCT scan that included RNFLT and TMV assessment at the start of the GA
* Having baseline clinical OCT scan that included RNFLT and TMV assessment (healthy controls)
* MS patients having a RR disease course (Lublin and Reingold, 1996)
* Age 18-65 (healthy controls will be matched to MS patients for age and sex)
* Signed informed consent at the 24-month follow-up
Exclusion Criteria
* Patients who received steroid treatment within 30 days prior to OCT scan date
* Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study
* MS patients who used other imunomodulatory or immunosuppressant treatment other than GA during the follow-up (e.g., IFN-β, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Teva Pharmaceuticals USA
INDUSTRY
University at Buffalo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Robert Zivadinov, MD, PhD
Director, Buffalo Neuroimaging Analysis Center, Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Zivadinov, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
SUNY University at Buffalo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Buffalo Neuroimaging Analysis Center
Buffalo, New York, United States
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.
GA-OCT
Identifier Type: -
Identifier Source: org_study_id