NL-OMON37946
Completed
Phase 3
A 3-year, multi-center study to evaluate optical coherencetomography as an outcome measure in patients with multiple sclerosis - CFTY720D2319
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- chronic impairment of the central nervous system
- Sponsor
- ovartis
- Enrollment
- 20
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria for patients with MS:
- •1\. Male and female patients aged 18\-55 years inclusive
- •2\. A diagnosis of MS as defined by the 2005 revision to the McDonald criteria with a
- •relapsing\-remitting course
- •3\. MS disease duration of more than one year (from diagnosis of MS) before study entry
- •(Screening);Inclusion criteria for participants in the reference group:
- •1\. Male and female subjects aged 18\-55 years inclusive.
- •2\. Matched to MS patients in terms of age (±3 years),
- •ethnicity, gender and visual refraction (±2 diopters) with the MS patients recruited.
Exclusion Criteria
- •Exclusion criteria for patients with MS and reference group:
- •1\. HIV or any other known immunodeficiency syndrome (disease or drug\-induced)
- •2\. Any ophthalmologic reason for RNFL pathology other than MS, such as optic neuropathy,
- •active advanced glaucoma, injury of the optic nerve or history or presence of severe
- •myopia based on the ophthalmologist\*s clinical judgment or \* history or presence of severe myopia: a. in patients who have not had refractive surgery, a refractive error of greater than 6\.00 diopters b. pathologic fundus changes of high myopia, such as retinal pigmentary atrophy, besides peripapillary atrophy (atrophy involving the macula) or a staphyloma c. in patients that have had previous refractive surgery, an axial eye length of greater than 26 mm
- •3\. Acute optic neuritis within the past 6 months before Baseline
- •4\. Evidence of advanced, non\-proliferative or proliferative diabetic retinopathy
- •5\. Presence of retinal conditions associated with edema, subretinal fluid, cysts, etc.
- •6\. History of a severe head trauma
- •7\. Any of the following neurologic/psychiatric disorders:
Outcomes
Primary Outcomes
Not specified
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