Efgartigimod for the Treatment of Acute Optic Neuritis
ConditionOptic Neuritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnastasia Vishnevetsky, MD, MPH
About this trial
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
Eligibility criteria
Qualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Adults aged 18 years or older
Diagnosed with a first episode of optic neuritis, based on clinical presentation (i.e. typical features such as pain with eye movements, color vision changes, subacute presentation, and visual acuity loss) and confirmed by contrast enhancement or T2 hyperintensity of the optic nerve on MRI brain or orbits using a 1.5T MRI scanner or greater
Disqualifiers
Current pregnancy or lactation
Known allergic reactions or intolerance to efgartigimod, methylprednisolone, prednisone, or gadolinium or any of their components
Known diagnosis of optic neuropathy preceding the current episode of optic neuritis
Evidence of a systemic disease other than MS, NMOSD, or MOGAD that might be associated with the optic neuritis
Trial design
Treatments tested in this trial
- Efgartigimod Alfa
- Placebo
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Anastasia Vishnevetsky, MD, MPH
Lead sponsor
Massachusetts General Hospital
Sponsor institution
argenx
Collaborator
Source ClinicalTrials.gov