NCT07623668RecruitingPhase 3
A Randomized, Double-masked, Placebo-controlled Study Assessing the Efficacy and Safety of Privosegtor (OCS-05) in Patients With Optic Neuritis (ON)
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Oculis
- Enrollment
- 210
- Locations
- 4
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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
Arms & Interventions
Privosegtor
Experimental
Intervention: Privosegtor (Drug)
Placebo
Placebo Comparator
Intervention: Methylprednisolone (Drug)
Privosegtor
Experimental
Intervention: Methylprednisolone (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Not specified
Secondary Outcomes
- Proportion of participants achieving at least 30-letter gain from baseline in low contrast visual acuity (LCVA).(3 months)
- Mean change from baseline in low contrast visual acuity (LCVA).(3 months)
Investigators
Study Sites (4)
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