Skip to content

A Randomized, Double-Masked, Placebo-Controlled Study Assessing the Efficacy and Safety Of Privosegtor (OCS-05) as add-on to IV Methylprednisolone in Participants with Optic Neuritis (PIONEER 1)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-525075-91-00
Enrollment
34
Registered
2026-08-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Optic Neuritis

Brief summary

Mean change from baseline in LCVA at Month 3 in the study eye.

Detailed description

•First (Key) Secondary: Proportion of participants achieving at least a 6-line (30-letter) gain from baseline in LCVA at Month 3 in the study eye., • Mean change from baseline in the GCIPL thickness as measured by optical coherence tomography (OCT) at Month 3 in the study eye., • Serum neurofilament light chain (sNfL) mean change from baseline through Month 3., •Mean change from baseline in NEI VFQ 25 at Month 3., •Mean change from baseline in NOS-10 at Month 3.

Interventions

DRUG0.9% sodium chloride sterile saline solution (sodium chloride [NaCl]) for IV infusion
DRUGmatching the solution used in preparing the active treatment.

Sponsors

Oculis Operations SARL
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Mean change from baseline in LCVA at Month 3 in the study eye.

Secondary

MeasureTime frame
•First (Key) Secondary: Proportion of participants achieving at least a 6-line (30-letter) gain from baseline in LCVA at Month 3 in the study eye., • Mean change from baseline in the GCIPL thickness as measured by optical coherence tomography (OCT) at Month 3 in the study eye., • Serum neurofilament light chain (sNfL) mean change from baseline through Month 3., •Mean change from baseline in NEI VFQ 25 at Month 3., •Mean change from baseline in NOS-10 at Month 3.

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 22, 2026