Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research

NCT07623668 — Phase 3, Recruiting, 210 participants, Oculis

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A Randomized, Double-masked, Placebo-controlled Study Assessing the Efficacy and Safety of Privosegtor (OCS-05) in Patients With Optic Neuritis (ON)

Registry	NCT07623668, acronym PIONEER-1
Status	Recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	210 (Estimated)
Sponsor	Oculis (Industry)
Conditions	Optic Neuritis
Interventions	Privosegtor, Methylprednisolone, Placebo (Drug, other)
Dates	start 2026-05-28, primary completion 2027-12-01 (estimated), completion 2028-12-01 (estimated), first posted 2026-06-03, last updated 2026-08-14
Locations	4 sites in United States

-Summary

The goal of this clinical trial is to evaluate the safety and efficacy of privosegtor, a neuroprotective candidate, in patients diagnosed with optic neuritis (ON).

Researchers will compare privosegtor and the standard of care (methylprednisolone) to a placebo and standard of care (methylprednisolone).

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+Arms and interventions

Arm	Type	Interventions	Description
Privosegtor	Experimental	Drug: Privosegtor; Drug: Methylprednisolone
Placebo	Placebo comparator	Drug: Methylprednisolone; Other: Placebo

Privosegtor (Drug): Privosegtor (OCS-05) 3 mg/kg/day IV for 5 treatment days
Methylprednisolone (Drug): Methylprednisolone 1 g/day IV for 5 treatment days
Placebo (Other): 0.9% sodium chloride (NaCl) solution IV for 5 treatment days

+Outcome measures

Primary outcomes

Proportion of participants achieving at least 15-letter gain from baseline in low contrast visual acuity (LCVA). [3 months]

Secondary outcomes

Proportion of participants achieving at least 30-letter gain from baseline in low contrast visual acuity (LCVA). [3 months]
Mean change from baseline in low contrast visual acuity (LCVA). [3 months]
Mean change from baseline in the ganglion cell - inner plexiform layer (GCIPL) thickness. [3 months]
Serum neurofilament light chain (sNfL) mean change from baseline. [Through month 3]

+Eligibility

Sex: All, ages: 18 Years to 50 Years

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

+Locations (4)

Facility	City	Country	Status
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