Optic Neuritis
Conditions
Keywords
Optic Neuritis, ON, AON, Optic Neuropathy, Multiple Sclerosis, MS, Vision Loss, LCVA, Low Contrast Visual Acuity, Low Contrast Sensitivity, Privosegtor, OCS-05
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).
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
Sponsors
Oculis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving at least 15-letter gain from baseline in low contrast visual acuity (LCVA). | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
United States
Contacts
CONTACTChief Development Officer
Outcome results
None listed