Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis

• Status: Unknown status
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedDay Pharmaceuticals SA

Criteria

Inclusion Criteria:

1. Diagnosis criteria of MS fulfilling revised Mc Donald criteria (2010)

2. Uni-or bilateral optic neuropathy with worst eye VA≤ 5/10 confirmed at 6 months

3. Worsening of visual acuity during the last three years

4. Informed consent prior to any study procedure

5. Patient aged 18-75 years

Exclusion Criteria:

1. Optic neuritis relapse within the three months before inclusion

2. Normal RNFL at OCT

3. Presence of other ocular pathology (glaucoma, cataract, retinopathy, anterior uveitis, myopia>7 dioptrics, intraocular pressure>20 mm Hg, amblyopia, retinal or optic head abnormalities (drusen, tilted disc)

4. Bilateral visual acuity <1/20

5. Visual impairment caused by ocular flutter or nystagmus

6. Pregnancy or childbearing potential woman without contraception

7. Any general chronic handicapping disease other than MS

8. New treatment introduced less than 3 months prior to inclusion or less than 1 month for Fampridine