Privosegtor for optic neuritis: a late-phase test with standard care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional study compares privosegtor plus methylprednisolone versus placebo plus methylprednisolone in adults aged 18 to 50 with their first unilateral optic neuritis episode and recent onset. Participants are randomized to receive either privosegtor or placebo alongside standard care to determine safety and efficacy. The study is conducted at multiple U.S. sites with primary ophthalmology and neurology involvement. The trial aims to determine if privosegtor can improve visual outcomes and preserve neural function in ON while maintaining acceptable safety. Key eligibility focuses on recent onset (within 12 days) and unilateral vision loss, with exclusion for conditions that could confound results or safety.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Adult men and women (aged 18 to 50 years) with the first episode of ON in the study eye, associated with unilateral visual loss.
* Onset of visual loss symptoms in the previous 12 days before first administration of study treatment.

Key Exclusion Criteria:

\- Have a history or presence of any disorder or condition that may, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety

Where it's running

• Kahana Oculoplastic and Orbital Surgery
  Livonia, Michigan, United States Recruiting
• Medical University of South Carolina, Storm Eye Institute
  Charleston, South Carolina, United States Recruiting
• UT Southwestern Medical Center (Ophthalmology CRU)
  Dallas, Texas, United States Recruiting
• Neuro-Eye Clinical Trials
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Chief Development Officer
• Email: info@oculis.com
• Phone: 617-928-5886

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Efgartigimod to speed vision recovery in acute optic neuritis

  This pilot will test whether efgartigimod given with standard steroids helps adults having their first episode of optic neuritis regain vision faster and more fully than placebo.

  Recruiting at 2 sites Phase 2 Massachusetts General Hospital · Boston, Massachusetts and 1 other locations · NCT06453694

• Using light stimulation to enhance vision after optic neuritis in multiple sclerosis patients

  This study is testing if light stimulation can help improve vision in people with multiple sclerosis who have had optic neuritis.

  Recruiting Technical University of Munich · Munich, Bavaria · NCT06389968

• Using edaravone to treat optic neuritis

  This study is testing if edaravone can help improve vision in Chinese adults who have recently experienced optic neuritis and have a specific antibody in their system.

  Recruiting First Affiliated Hospital of Guangxi Medical University · Nanning · NCT05540262

• Understanding visual pathways in neuro-inflammatory disorders

  This study looks at how optic neuritis affects vision in people with neuroinflammatory diseases like multiple sclerosis to better understand the damage it causes.

  Recruiting University Hospital, Lille · Lille · NCT05487989

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.