Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research

NCT07623668 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: PR-5301
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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

Keywords

Optic Neuritis, ON, AON, optic neuropathy, multiple sclerosis, MS, vision loss, LCVA, low contrast visual acuity, low contrast sensitivity; privosegtor, OCS-05

Outcome Measures

Primary Outcomes (1)

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

  3 months

Secondary Outcomes (4)

• Proportion of participants achieving at least 30-letter gain from baseline in LCVA.

  3 months

• Mean change from baseline in LCVA.

  3 months

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

  3 months

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

  Through month 3

Study Arms (2)

Privosegtor

EXPERIMENTAL

Drug: Privosegtor; Drug: Methylprednisolone

Placebo

PLACEBO COMPARATOR

Drug: Methylprednisolone; Other: Placebo

Interventions

Privosegtor DRUG

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

Privosegtor

Methylprednisolone DRUG

Methylprednisolone 1 g/day IV for 5 treatment days

Placebo; Privosegtor

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Oculis: lead

Study Sites (1)

Neuro-Eye Clinical Trials

Houston, Texas, 77074, United States

RECRUITING

MeSH Terms

Conditions

Optic Neuritis; Optic Nerve Diseases; Multiple Sclerosis; Vision Disorders

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Chief Development Officer

CONTACT

617-928-5886; info@oculis.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start: May 28, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

US (1)