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Efgartigimod for the Treatment of Acute Optic Neuritis — PET-AON  

Optic Neuritis Clinical Trial

Official title:
A Pilot Randomized Trial of Efgartigimod Alfa for the Treatment of Incident Moderate to Severe Acute Optic Neuritis

Clinical Trial Summary

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

Clinical Trial Description

This study is designed as a pilot, single-site, randomized, placebo-controlled, 2-arm, parallel-group clinical trial comparing efgartigimod alfa in addition to standard of care (IV steroids with a standardized oral taper) to standard of care with placebo, with an option for rescue therapy with plasma exchange for all participants in the case of poor therapeutic response. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06453694
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Not yet recruiting
Phase Phase 2
Start date October 2024
Completion date July 2027
View Details
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