Studying the Effects of Copaxone on Retinal Health Using Optical Tomography Over 24 Months

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Multiple Sclerosis

Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Copaxone<br>Patients with multiple sclerosis who are currently prescribed glatiramer acitate (Copaxone) | |
| OCT<br>Healthy controls | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal health in multiple sclerosis patients prescribed copaxone | Participants will have an OCT retinal health will be determined by degree of axonal loss. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring disability progression | Investigating the effect of copaxone on total macular volume on OCT in patients with RRMS. Exploring progression of disability as measured by Expanded Disability Status Scale (EDSS). | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCT, Copaxone, Multiple sclerosis, relapsing-remitting