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.
Efgartigimod for the Treatment of Acute Optic Neuritis
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Anastasia Vishnevetsky, MD, MPH · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
Who to contact
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What this trial measures
- 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