Optic NeuritisPhase 3PIONEER-1NCT07623668
Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research
A Phase 3 study testing Privosegtor and Methylprednisolone in people with Optic Neuritis, run by Oculis at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Optic Neuritis
- What is being tested?
- Privosegtor and Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 May 2026to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Medical University of South Carolina, Storm Eye Institute
Charleston, South Carolina, 29425
- Recruiting
UT Southwestern Medical Center (Ophthalmology CRU)
Dallas, Texas, 75390
Ruben Jauregui, MD, 214-645-2014, OphthaResearch@UTSouthwestern.edu
- Recruiting
Neuro-Eye Clinical Trials
Houston, Texas, 77074
Mirna Maldonado, 713-894-4393, Rtang@neuroeye.com
- Recruiting
Kahana Oculoplastic and Orbital Surgery
Livonia, Michigan, 48152
Dr. Victoria Williams, 248-800-1177, kcrc@mioculoplastics.com
About this study
Official title: 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).
- Conditions
- Optic Neuritis
- Being tested
- Privosegtor, Methylprednisolone, Placebo
- Keywords
- Optic Neuritis, ON, AON, Optic Neuropathy, Multiple Sclerosis, MS, Vision Loss, LCVA, Low Contrast Visual Acuity, Low Contrast Sensitivity, Privosegtor, OCS-05
- Medical subject headings
- Optic Neuritis, Optic Nerve Diseases, Multiple Sclerosis, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrivosegtorDrug
Privosegtor (OCS-05) 3 mg/kg/day IV for 5 treatment days
Methylprednisolone 1 g/day IV for 5 treatment days
PlaceboOther
0.9% sodium chloride (NaCl) solution IV for 5 treatment days
| Study group | Role | What they receive |
|---|---|---|
| Privosegtor | Experimental | Not described Receives: Drug: Privosegtor; Drug: Methylprednisolone |
| Placebo | Placebo comparator | Not described Receives: Drug: Methylprednisolone; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving at least 15-letter gain from baseline in low contrast visual acuity (LCVA).
Measured: 3 months
Secondary outcomes (4)
Proportion of participants achieving at least 30-letter gain from baseline in low contrast visual acuity (LCVA).
Measured: 3 months
Mean change from baseline in low contrast visual acuity (LCVA).
Measured: 3 months
Mean change from baseline in the ganglion cell - inner plexiform layer (GCIPL) thickness.
Measured: 3 months
Serum neurofilament light chain (sNfL) mean change from baseline.
Measured: Through month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start28 May 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic NeuritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oculis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623668
- Sponsor's protocol ID
- PR-5301
- Acronym
- PIONEER-1
- Status last verified
- Aug 2026
- First submitted
- 28 May 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-masked, Placebo-controlled Study Assessing the Efficacy and Safety of Privosegtor (OCS-05) in Patients With Optic Neuritis (ON)
- ClinicalTrials.gov ID
- NCT07623668
- Acronym / sponsor ID
- PIONEER-1 / PR-5301
- Conditions
- Optic Neuritis
- Keywords
- Optic Neuritis, ON, AON, Optic Neuropathy, Multiple Sclerosis, MS, Vision Loss, LCVA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- OculisIndustry (pharma, biotech, devices)
- Study start
- 28 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Privosegtor | Experimental | Drug: Privosegtor, Drug: Methylprednisolone |
| Placebo | Placebo comparator | Drug: Methylprednisolone, Other: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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 (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrivosegtorPrivosegtor (OCS-05) 3 mg/kg/day IV for 5 treatment days | Drug | Privosegtor |
| MethylprednisoloneMethylprednisolone 1 g/day IV for 5 treatment days | Drug | Placebo, Privosegtor |
| Placebo0.9% sodium chloride (NaCl) solution IV for 5 treatment days | Other | Placebo |
Primary outcome
Proportion of participants achieving at least 15-letter gain from baseline in low contrast visual acuity (LCVA).
Time frame: 3 months
4 secondary outcomes
Proportion of participants achieving at least 30-letter gain from baseline in low contrast visual acuity (LCVA).
Time frame: 3 months
Mean change from baseline in low contrast visual acuity (LCVA).
Time frame: 3 months
Mean change from baseline in the ganglion cell - inner plexiform layer (GCIPL) thickness.
Time frame: 3 months
Serum neurofilament light chain (sNfL) mean change from baseline.
Time frame: Through month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Privosegtor and Methylprednisolone in people with Optic Neuritis, run by Oculis at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chief Development Officer (617-928-5886, info@oculis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving at least 15-letter gain from baseline in low contrast visual acuity (LCVA). (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.