What this study is
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).
What's being tested
- Privosegtor
Intervention · DRUG
Privosegtor (OCS-05) 3 mg/kg/day IV for 5 treatment days
- Methylprednisolone
Intervention · DRUG
Methylprednisolone 1 g/day IV for 5 treatment days
- Placebo
Intervention · OTHER
0.9% sodium chloride (NaCl) solution IV for 5 treatment days
Study details
- Official title
- A Randomized, Double-masked, Placebo-controlled Study Assessing the Efficacy and Safety of Privosegtor (OCS-05) in Patients With Optic Neuritis (ON)
- Sponsor
- Oculis
- Conditions
- Optic Neuritis
- Enrolling
- 210 people
- Starts
- 2026-05-28
- Est. completion
- 2028-12
- Design
- Quadruple-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 50 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openKahana Oculoplastic and Orbital Surgery
Livonia, Michigan, United States
- Dr. Victoria Williams · Contact248-800-1177kcrc@mioculoplastics.com
RecruitingMedical University of South Carolina, Storm Eye Institute
Charleston, South Carolina, United States
RecruitingUT Southwestern Medical Center (Ophthalmology CRU)
Dallas, Texas, United States
- Ruben Jauregui, MD · Contact214-645-2014OphthaResearch@UTSouthwestern.edu
RecruitingNeuro-Eye Clinical Trials
Houston, Texas, United States
- Mirna Maldonado · Contact713-894-4393Rtang@neuroeye.com
Recruiting
Study team
Sponsor
Oculis
Study ID PR-5301
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.