Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research (PIONEER-1)

May 28, 2026 updated by: Oculis

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77074
        • Recruiting
        • Neuro-Eye Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants achieving at least 15-letter gain from baseline in low contrast visual acuity (LCVA).
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants achieving at least 30-letter gain from baseline in LCVA.
Time Frame: 3 months
3 months
Mean change from baseline in LCVA.
Time Frame: 3 months
3 months
Mean change from baseline in the ganglion cell - inner plexiform layer (GCIPL) thickness.
Time Frame: 3 months
3 months
Serum neurofilament light chain (sNfL) mean change from baseline.
Time Frame: Through month 3
Through month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oculis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

May 28, 2026

First Submitted That Met QC Criteria

May 28, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-5301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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