Efgartigimod for Optic Neuritis
(PET-AON Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byAnastasia Vishnevetsky, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Anastasia Vishnevetsky, MD, MPH

Prior Safety Data

Trial Summary

What is the purpose of 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

This trial is for adults experiencing their first episode of optic neuritis, which is inflammation of the optic nerve. Participants must be willing to undergo vision and blood tests, answer questions about their vision, receive standard steroid treatment, and attend periodic visits over a six-month period.

Inclusion Criteria

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

I am using effective birth control methods if I am capable of fathering a child.

+5 more

Exclusion Criteria

I had a major surgery recently.

Current pregnancy or lactation

I cannot undergo MRI or plasma exchange due to health reasons.

+13 more

Participant Groups

The study is testing efgartigimod alfa against a placebo in treating acute optic neuritis. It aims to determine if efgartigimod alfa can be feasibly used for this condition and whether it's more effective than a placebo in restoring vision quickly and significantly.

2Treatment groups

Active Control

Placebo Group

Group I: Efgartigmod alfaActive Control1 Intervention

10 patients will receive efgartigimod alfa All participants will receive standard of care high dose corticosteroids for 3 days with a prednisone taper over 3 weeks.

Group II: PlaceboPlacebo Group1 Intervention

10 patients will receive placebo. All participants will receive standard of care high dose corticosteroids for 3 days with a prednisone taper over 3 weeks.