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

University at Buffalo

Status: Completed

Conditions: Multiple Sclerosis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02017808

GA-OCT

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

100 participants in 2 patient groups

Copaxone

Description:

Patients with multiple sclerosis who are currently prescribed glatiramer acitate (Copaxone)

OCT

Description:

Healthy controls