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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02017808

Acronym

GAO

Enrollment

100

Registered

2013-12-23

Start date

2014-02-28

Completion date

2014-12-31

Last updated

2014-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

OCT, Copaxone, Multiple sclerosis, relapsing-remitting

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

United States

Outcome results