The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the visual improvement of patients suffering from chronic visual loss resulting from multiple sclerosis related optic neuritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
105
Hopital Pellegrin
Bordeaux, France
Hopital de la cote de Nacre
Caen, France
Change from baseline of the best corrected visual acuity at 100% contrast
Best corrected visual acuity using the ETDRS logMar chart at 100% contrast
Time frame: Baseline, 6 months
Visual field mean deviation change from baseline
Visual field analyses are performed using the standard automated perimetry method
Time frame: Baseline, 6 months, 12 months
Reappearance or improvement of the P00 wave on Visual Evoked Potential
Two parameters will be evaluated: (1) presence of a clear P100 wave, (2) P100 latency
Time frame: Baseline, 6 months, 12 months
Optical Coherence Tomography
Values of RNFL thickness and macular volume
Time frame: Baseline, 6 months, 12 months
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Hopital Gabriel Montpied
Clermont-Ferrand, France
Hopital general du Bocage
Dijon, France
CHRU de Lille
Lille, France
Hopital Pierre Wertheimer
Lyon, France
Hopital de la Timone
Marseille, France
Hopital Gui de Chauliac
Montpellier, France
Hopital Central
Nancy, France
Hopital Nord Laennec
Nantes, France
...and 10 more locations