Studying the Effects of Copaxone on Retinal Health Using Optical Tomography Over 24 Months
Studying the Effects of Copaxone on Retinal Health Using Optical Tomography Over 24 Months
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.
The primary aim of this study is to explore whether treatment with Copaxone may decrease
 accumulation of axonal loss, as measured by retinal nerve fiber layer thickness (RNFLT) on
 optical coherence tomography (OCT) in patients with RRMS over 24 months and compared to a
 reference population of healthy controls.

 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).
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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.)