Studying the Effects of Copaxone on Retinal Health Using Optical Tomography Over 24 Months
Completed
Conditions studied: Multiple Sclerosis
In brief
This is a prospective, observational, single-blinded, longitudinal, 24-month OCT study of the evolution of axonal loss, as evidenced by loss of RNFLT and TMV, in RRMS patients treated with GA and in healthy controls.
Key facts
- Study ID
- NCT02017808
- Run by
- University at Buffalo
- People needed
- 100
- Starts
- 2014-02-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2014-12-03
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- MS patients diagnosed with clinically definite MS according to the McDonald criteria (Polman et al., 2005)
- 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
- None of the exclusion criteria
You may not qualify if…
- Patients who had a relapse within 30 days prior to OCT scan date
- 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.)
Where it is running
- Buffalo Neuroimaging Analysis Center — Buffalo, New York, United States
Full record on ClinicalTrials.gov
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