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Recruiting NCT07623668

Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research

Phase III Interventional Optic Neuritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Privosegtor, Methylprednisolone, Placebo.
Who it may be relevant to
Registry conditions: Optic Neuritis. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-masked, Placebo-controlled Study Assessing the Efficacy and Safety of Privosegtor (OCS-05) in Patients With Optic Neuritis (ON)

Overview

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

  • Drug Privosegtor
    Privosegtor (OCS-05) 3 mg/kg/day IV for 5 treatment days
  • Drug Methylprednisolone
    Methylprednisolone 1 g/day IV for 5 treatment days
  • Other Placebo
    0.9% sodium chloride (NaCl) solution IV for 5 treatment days

Primary outcome measures

  • Proportion of participants achieving at least 15-letter gain from baseline in low contrast visual acuity (LCVA). [Time frame: 3 months]
Secondary outcome measures (4)
  • Proportion of participants achieving at least 30-letter gain from baseline in low contrast visual acuity (LCVA). [Time frame: 3 months]
  • Mean change from baseline in low contrast visual acuity (LCVA). [Time frame: 3 months]
  • Mean change from baseline in the ganglion cell - inner plexiform layer (GCIPL) thickness. [Time frame: 3 months]
  • Serum neurofilament light chain (sNfL) mean change from baseline. [Time frame: Through month 3]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Kahana Oculoplastic and Orbital Surgery — Livonia
  • Neuro-Eye Clinical Trials — Houston

Identifiers

NCT: NCT07623668 · PR-5301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗