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NCT Number: NCT07623668

Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research

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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Key information

Conditions

Optic Neuritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases Neurologic Manifestations Optic Nerve Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kahana Oculoplastic and Orbital Surgery, Livonia, Michigan, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 3 months

Secondary outcomes

  1. Proportion of participants achieving at least 30-letter gain from baseline in low contrast visual acuity (LCVA).

    Time frame: 3 months

  2. Mean change from baseline in low contrast visual acuity (LCVA).

    Time frame: 3 months

  3. Mean change from baseline in the ganglion cell - inner plexiform layer (GCIPL) thickness.

    Time frame: 3 months

  4. Serum neurofilament light chain (sNfL) mean change from baseline.

    Time frame: Through month 3

Study contacts

Contact information is provided by the study sponsor or research team.

Chief Development Officer

CONTACT

[email protected]

617-928-5886

Sponsors and collaborators

Lead sponsor

Oculis

Industry

Registry information

Official study title

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

Acronym: PIONEER-1

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 3, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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