Clinical trial NCT02017808: Studying the Effects of Copaxone on Retinal Health Using Optical Tomography Over 24 Months
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: OCT
Copaxone
Multiple sclerosis
relapsing-remitting
Lead sponsor: University at Buffalo
Sponsor class: OTHER
Collaborators: name: Teva Pharmaceuticals USA
First posted: 2013-12-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with relapsing remitting multiple sclerosis Healthy controls without known neurological problems.

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.

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).

Eligibility criteria: 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.)

Primary outcomes:
measure: Retinal health in multiple sclerosis patients prescribed copaxone
timeFrame: 24 months
Secondary outcomes:
measure: Measuring disability progression
timeFrame: 24 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Buffalo Neuroimaging Analysis Center
state: New York
Study officials:
affiliation: SUNY University at Buffalo
name: Robert Zivadinov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: