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NCT06453694 · ClinicalTrials.gov registry record · Phase 2
Efgartigimod for the Treatment of Acute Optic Neuritis
A Phase 2 study of Optic Neuritis, sponsored by Anastasia Vishnevetsky, MD, MPH.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT06453694: Recruiting Phase 2 study of Optic Neuritis, sponsored by Anastasia Vishnevetsky, MD, MPH.
NCT06453694 is a Phase 2 study of Optic Neuritis that is actively recruiting participants, run by Anastasia Vishnevetsky, MD, MPH. The registered enrollment target is 20 participants, below the 801-participant average among 5 other Optic Neuritis trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06453694, a Phase 2 study of Optic Neuritis, is actively recruiting participants, sponsored by Anastasia Vishnevetsky, MD, MPH.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study 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
Primary Outcome
Number of enrolled participants per month
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Efgartigimod Alfa
Study Locations (2)
Massachusetts
- Massachusetts Eye and Ear Infirmary - Boston
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-08-12 |
| Est. Completion | 2027-07 |
| Phase | Phase 2 |
What NCT06453694 shows while recruiting
NCT06453694 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 801-participant average among 5 other Optic Neuritis trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Optic Neuritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06453694 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06453694 about?
NCT06453694 is a clinical study titled "Efgartigimod for the Treatment of Acute Optic Neuritis". 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 test...
What is the current status of trial NCT06453694?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2025-08-12. Estimated completion is 2027-07.
What conditions does trial NCT06453694 study?
This clinical trial studies the following conditions: Optic Neuritis.
What interventions are being tested in trial NCT06453694?
The interventions under investigation include: Placebo (DRUG), Efgartigimod Alfa (DRUG).
Who is sponsoring clinical trial NCT06453694?
This trial is sponsored by Anastasia Vishnevetsky, MD, MPH, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06453694 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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