Actively Recruiting
Efgartigimod for the Treatment of Acute Optic Neuritis
Led by Anastasia Vishnevetsky, MD, MPH · Updated on 2025-11-10
20
Participants Needed
2
Research Sites
98 weeks
Total Duration
On this page
Sponsors
A
Anastasia Vishnevetsky, MD, MPH
Lead Sponsor
A
argenx
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this pilot clinical trial is to test efgartigimod alfa against placebo in adults with first-time optic neuritis (optic nerve inflammation). The main questions it aims to answer are: * Is it feasible to use efgartigimod alfa for optic neuritis? * Is it feasible to run a larger trial testing efgartigimod alfa in optic neuritis? * Does efgartigimod alfa work better than placebo in improving how quickly and how much vision returns? Participants will: * have their vision and blood tested * be asked questions about their vision * will receive standard of care treatment with steroids regardless of whether they are receiving efgartigimod alfa or not * will have periodic visits over 6 months
CONDITIONS
Official Title
Efgartigimod for the Treatment of Acute Optic Neuritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Willingness to follow all study procedures and be available for the entire study
- Adults aged 18 years or older
- Diagnosed with a first episode of optic neuritis confirmed by clinical signs and MRI
- Onset of optic neuritis-related vision changes within 10 days before enrollment
- Best-corrected high contrast visual acuity of 20/60 or worse in the worse eye
- For females of reproductive potential: negative pregnancy test or use of effective contraception before and during study, and for 8 weeks after treatment
- For males of reproductive potential: use of condoms or other effective contraception methods
You will not qualify if you...
- Current pregnancy or breastfeeding
- Known allergies or intolerance to study drugs or their components
- Previous optic neuropathy diagnosis before current optic neuritis
- Systemic diseases other than MS, NMOSD, or MOGAD linked to optic neuritis
- Receiving immunomodulatory or immunosuppressive therapy at enrollment or planned within 3 weeks after treatment
- Known CNS demyelinating diseases diagnosed before current attack
- Significant eye conditions causing vision loss prior to optic neuritis (except congenital color-blindness)
- Other causes for vision changes found on eye exams
- Participation in another investigational study within 2 months
- Contraindications to MRI or plasma exchange
- More than 3 days of high-dose steroids received for current optic neuritis before randomization
- Known HIV or common variable immunodeficiency
- History of cancer unless cured with no recurrence for at least 1 year, except certain skin or in situ cancers
- Active or chronic serious infections
- Recent major surgery within 1 month or planned surgery during study
- Any condition that may risk safety, affect results, or make participation unsuitable according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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