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Clinical Trials/EUCTR2011-001437-16-DE
EUCTR2011-001437-16-DE
Active, not recruiting
Phase 1

A 3-year, multi-center study to evaluate optical coherence tomography as an outcome measure in patients with multiple sclerosis

ovartis Pharma Services AG0 sites422 target enrollmentFebruary 9, 2012
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Conditionsmultiple sclerosisMedDRA version: 15.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsGilenyaExtaviaTysabriCopaxoneAvonex

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
multiple sclerosis
Sponsor
ovartis Pharma Services AG
Enrollment
422
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 9, 2012
End Date
August 7, 2017
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Patients eligible for inclusion in this study have to fulfill the following criteria:
  • •Written informed consent must be obtained before any assessment is performed
  • •Male and female patients aged 18\-55 years inclusive
  • •A diagnosis of MS as defined by the 2005 revision to the McDonald criteria with a relapsingremitting
  • •MS disease duration of more than one year (from diagnosis of MS) before study entry (Screening) Participants of the reference group eligible for inclusion have to fulfill the following criteria:
  • •Written informed consent must be obtained before any assessment is performed
  • •Male and female subjects aged 18\-55 years inclusive
  • •Matched to MS patients recruited in terms of age (±3 years),
  • •ethnicity, gender and visual refraction (±2 diopters) with the MS patients recruited.
  • •Are the trial subjects under 18? no

Exclusion Criteria

  • •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 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:
  • •history of substance abuse (drug or alcohol) in the past five years or any other factor (i.e., serious psychiatric condition) that may interfere with the subject’s ability to cooperate and comply with the study procedures • specific MRI findings (tumor, subdural haematoma, post\-contusional changes, territorial stroke, neurodegenerative disorders, aneurysm/arteriovenous malformation, evidence of past macroscopic haemorrhage, or other relevant MRI findings that would interfere with evaluation) • progressive neurological disorder, other than MS, which may affect participation in the study
  • •8\. Concomitant use of drugs that may directly affect retinal structure and function (e.g. chronic systemic corticosteroids \[\>30 consecutive days; doses higher than Cushing threshold e.g. prednisone 7\.5mg/d], intraocular anti\-angiogenic drugs \[ranibizumab, bevacizumab], intraocular steroids etc.)
  • •9\. Any medically unstable condition, progressive disease (other than MS) or other condition that would preclude reliable participation in the study as assessed by the investigator

Outcomes

Primary Outcomes

Not specified

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