Recruiting
Phase 3

Privosegtor vs. Methylprednisolone

Sponsor:

Oculis

Code:

NCT07623668

Conditions

Optic Neuritis

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Privosegtor

Methylprednisolone

Placebo

Study Details

Brief 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).

Conditions

Optic Neuritis

Study ID

NCT07623668

Start date

May 28, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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 Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Privosegtor

placebo comparator: Placebo

Interventions

Privosegtor

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

Methylprednisolone

Methylprednisolone 1 g/day IV for 5 treatment days

Placebo

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Chief Development Officer

617-928-5886info@oculis.com

Locations

Kahana Oculoplastic and Orbital Surgery

Recruiting

Livonia, Michigan, United States, 48152

Contacts

Dr. Victoria Williams

248-800-1177kcrc@mioculoplastics.com

Medical University of South Carolina, Storm Eye Institute

Recruiting

Charleston, South Carolina, United States, 29425

UT Southwestern Medical Center (Ophthalmology CRU)

Recruiting

Dallas, Texas, United States, 75390

Contacts

Ruben Jauregui, MD

214-645-2014OphthaResearch@UTSouthwestern.edu

Neuro-Eye Clinical Trials

Recruiting

Houston, Texas, United States, 77074

Contacts

Mirna Maldonado

713-894-4393Rtang@neuroeye.com

More Information

Sponsor

Oculis

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Oculis on 2026-08-14.