Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis (NCT02220244) | Clinical Trial Compass
UnknownPhase 3
Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis
France, United Kingdom105 participantsStarted 2013-10
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Diagnosis criteria of MS fulfilling revised Mc Donald criteria (2010)
. Uni-or bilateral optic neuropathy with worst eye VA≤ 5/10 confirmed at 6 months
. Worsening of visual acuity during the last three years
. Informed consent prior to any study procedure
. Patient aged 18-75 years
Exclusion criteria
. Optic neuritis relapse within the three months before inclusion
. Normal RNFL at OCT
. 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)
. Bilateral visual acuity \<1/20
. Visual impairment caused by ocular flutter or nystagmus
. Pregnancy or childbearing potential woman without contraception
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline of the best corrected visual acuity at 100% contrast