Multiple Sclerosis Clinical Trial
Official title:
A Prospective, Observational, Single-blinded, Longitudinal Optical Coherence Tomography Study of Effect of Copaxone (Glatiramer Acetate) on Retinal Nerve Fiber Layer Thickness in Patients With Relapsing-remitting Multiple Sclerosis 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).
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Observational Model: Cohort, Time Perspective: Prospective
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