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RecruitingNCT07623668PIONEER-1Updated Aug 14, 2026

Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research

A Phase 3 interventional study of Privosegtor and Methylprednisolone in Optic Neuritis, sponsored by Oculis. Recruiting at 4 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Oculis · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Optic Neuritis

Keywords

  • Optic Neuritis
  • ON
  • AON
  • Optic Neuropathy
  • Multiple Sclerosis
  • MS
  • Vision Loss
  • LCVA
  • Low Contrast Visual Acuity
  • Low Contrast Sensitivity
  • Privosegtor
  • OCS-05
03

In context

Optic Neuritis

88 studies on the registry are indexed under Optic Neuritis; 16 are open to participants now.

This study's planned enrollment of 210 is above the median of 50 across 58 interventional studies indexed under Optic Neuritis.

Browse Optic Neuritis studies →

Lead sponsor

Oculis is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
210 participants (estimated)

Study arms

  • Experimental
    Privosegtor

    Drug: Privosegtor · Drug: Methylprednisolone

  • Placebo comparator
    Placebo

    Drug: Methylprednisolone · Other: Placebo

Interventions

  • DrugPrivosegtor

    Privosegtor (OCS-05) 3 mg/kg/day IV for 5 treatment days

  • Methylprednisolone 1 g/day IV for 5 treatment days

  • OtherPlacebo

    0.9% sodium chloride (NaCl) solution IV for 5 treatment days

06

What researchers measure

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

07

Study locations

4 of 4 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2026 (actual). Primary completion is estimated for Dec 2027, 19 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 28, 2026
First posted
Jun 3, 2026
StartActual
May 28, 2026
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2028
Last update
Aug 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07623668
Lead sponsor
Oculis
Responsible party
Sponsor
First posted
Jun 3, 2026
Start date
May 28, 2026
Primary completion
Dec 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Aug 14, 2026

Study contacts

Chief Development Officer
Contact
info@oculis.com
617-928-5886

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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