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

Multiple Sclerosis Clinical Trial

— GAO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02017808
• Other study ID #: GA-OCT
• Status: Completed
• Phase: N/A
• First received: December 4, 2013
• Last updated: December 1, 2014
• Start date: February 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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-ß, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Locations

Country	Name	City	State
United States	Buffalo Neuroimaging Analysis Center	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
University at Buffalo	Teva Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No