A Randomized, Double-masked, Placebo-controlled Study Assessing the Efficacy and Safety of Privosegtor (OCS-05) in Patients With Optic Neuritis (ON)
Oculis
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).
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DrugPrivosegtor
Privosegtor (OCS-05) 3 mg/kg/day IV for 5 treatment days
- DrugMethylprednisolone
Methylprednisolone 1 g/day IV for 5 treatment days
- OtherPlacebo
0.9% sodium chloride (NaCl) solution IV for 5 treatment days
Location
- Neuro-Eye Clinical TrialsHouston, Texas