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

Oculis

Status and phase

Enrolling

Phase 3

Conditions

Optic Neuritis

Treatments

Other: Placebo

Drug: Methylprednisolone

Drug: Privosegtor

Study type

Interventional

Funder types

Industry

Identifiers

NCT07623668

PR-5301

Details and patient eligibility

About

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).

Enrollment

210 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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