Optical Coherence Tomography: Glatiramer in Clinically Isolated Syndrome or Early Relapsing Remitting Multiple Sclerosis (MS)
Optical Coherence Tomography: Glatiramer in Clinically Isolated Syndrome or Early Relapsing Remitting Multiple Sclerosis (MS)
This is a study in patients with clinically isolated syndrome (CIS) and early relapsing
 remitting multiple sclerosis (RRMS) to assess the effects of glatiramer acetate (GA)
 subcutaneously on the condition of the optical nerve in comparison to no medicinal therapy
 during 12 months and to assess the use of Optical Coherence tomography (OCT), a non-invasive
 ophthalmological technique, in daily practice as an alternative to magnetic resonance imaging
 (MRI) scanning for follow-up of these patients.
Multiple sclerosis (MS) is a progressive and demyelinating disease of the central nervous
 system characterized by inflammation and neurodegeneration. It is characterized by an ongoing
 process of demyelination and axonal loss, even at the beginning of the disease course, which
 will result in brain atrophy. A first manifestation of clinical definite MS, is called a
 clinically isolated syndrome (CIS). Brain atrophy occurs even in patients with a CIS. Optic
 neuritis (ON) is a common feature of a CIS. The axons in the retina represent the most
 proximal part of the optic nerve which is devoid of myelin. Because the retina is part of the
 central nervous system (CNS), measurement of the Retinal Nerve Fiber Layer (RFLN) by Optical
 Coherence Tomography (OCT) offers the opportunity to visualize the unmyelinated axons of the
 CNS directly. OCT is a non-invasive method to measure the thickness of the optical layer. The
 thickness of the RNFL is reduced in MS patients with or without ON history.

 Glatiramer acetate (GA), an immunomodulatory drug for RRMS and CIS, reduces brain atrophy and
 stimulates the production of brain-derived neurotrophic factor, which in turn could stimulate
 neuroregeneration.

 In this pilot study we would like to assess the feasibility of OCT measurement in patient
 with CIS other than ON in the Dutch clinical setting and to assess the effect of GA on the
 RNFL and visual function in patients with CIS or in early relapsing remitting MS patients.
Inclusion Criteria:

 -  Age: 18 - 55 years

 -  Early relapsing remitting MS, defined as a disease course less than 3 years

 -  clinically isolated syndrome , defined as optic neuritis (ON) or other than ON

 -  Currently treated with glatiramer (GA) or currently not treated for MS

 -  Expanded disability status scale (EDSS) score 0-5

 -  Able and willing to provide written informed consent prior to enrolment

 -  Willing and able to comply with the protocol requirements for the duration of the
 study

 Exclusion Criteria:

 -  Clinical definite multiple sclerosis with a disease course more than 3 years

 -  Primary progressive multiple sclerosis

 -  Secondary progressive multiple sclerosis

 -  Current use of any approved or investigational disease modifying agents for the
 treatment of MS other than GA.

 -  Neuromyelitis Optica (Devic's disease)

 -  Any condition that may interfere with the quality of the OCT scan: clouding of the
 media, i.e. cataract, pupil which are hard to dilate.

 -  Contra-indications for Copaxone ® as defined in the Summary of Product Characteristics
 (SPC) text

 -  Hypersensitivity to GA or mannitol

 -  Subject's inability to complete the study or if the subject is considered by the
 investigator to be for any reason, an unsuitable candidate for this study.