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

Sponsor

University at Buffalo (Other)

Overall Status

Completed

CT.gov ID

NCT02017808

Collaborator

Teva Pharmaceuticals USA (Industry)

100

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis

Detailed 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).

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Copaxone Patients with multiple sclerosis who are currently prescribed glatiramer acitate (Copaxone)
OCT Healthy controls

Outcome Measures

Primary Outcome Measures

Retinal health in multiple sclerosis patients prescribed copaxone [24 months]
Participants will have an OCT retinal health will be determined by degree of axonal loss.

Secondary Outcome Measures

Measuring disability progression [24 months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.)