Efgartigimod for First-Time Optic Neuritis

This study is testing a drug called efgartigimod alfa for adults who have experienced their first episode of optic neuritis (inflammation of the optic nerve). Researchers want to see if efgartigimod alfa, given as a shot under the skin, can help improve vision faster and better than a placebo (an inactive substance). All participants will also receive standard steroid treatment. The main goals are to see if it's practical to use efgartigimod alfa for optic neuritis and if a larger study would be worthwhile. They will also look at how much vision improves after one month. You would be eligible if you are an adult aged 18 or older with a new diagnosis of optic neuritis.

Study design
This is a pilot study, meaning it's a small-scale test, with 20 participants. It's a randomized, placebo-controlled study, so some participants will receive efgartigimod alfa and others will receive a placebo, but you won't know which one you're getting.
What's involved
You would have your vision and blood tested, answer questions about your vision, and receive injections on Day 0 and Day 3. You would have periodic visits over 6 months.
Compensation
Not stated in the trial record.
Follow-up
The study will measure changes in vision for one month after treatment. The overall study adherence and recruitment rates will be measured for two years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06453694

Efgartigimod for the Treatment of Acute Optic Neuritis

Recruiting
PHASE2Ages 18+InterventionalTreatment
Anastasia Vishnevetsky, MD, MPH
~20 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:Efgartigimod AlfaPlacebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recruitment Rate
Measured over 2 years
+3 more outcomes measured
Optic Neuritis
2 sites across 1 states
Massachusetts2
  • Anastasia Vishnevetsky, MD, MPH · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

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  • Recruitment Rate2 years

    Number of enrolled participants per month

  • Study Adherence Rate2 years

    Proportion of randomized participants who receive both doses of assigned study intervention, attend all assigned study visits, and complete at least the high contrast visual acuity, low contrast visual acuity, and Pelli-Robson assessments at all visits

  • Change in high contrast visual acuity for effect size and standard deviation estimation1 month

    Difference in change in high-contrast visual acuity from baseline to 1 month between groups

  • Change in low contrast visual acuity for effect size and standard deviation estimation1 month

    Difference in change in low contrast visual acuity (LCVA) (# of letters seen at 2.5% illumination) from baseline to 1 month between groups