Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research

Purpose

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).

Condition

  • Optic Neuritis

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Privosegtor
  • 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
Placebo Comparator
Placebo
  • Drug: Methylprednisolone
    Methylprednisolone 1 g/day IV for 5 treatment days
  • Other: Placebo
    0.9% sodium chloride (NaCl) solution IV for 5 treatment days

Recruiting Locations

Kahana Oculoplastic and Orbital Surgery
Livonia, Michigan 48152
Contact:
Dr. Victoria Williams
248-800-1177
kcrc@mioculoplastics.com

Medical University of South Carolina, Storm Eye Institute
Charleston, South Carolina 29425

UT Southwestern Medical Center (Ophthalmology CRU)
Dallas, Texas 75390
Contact:
Ruben Jauregui, MD
214-645-2014
OphthaResearch@UTSouthwestern.edu

Neuro-Eye Clinical Trials
Houston, Texas 77074
Contact:
Mirna Maldonado
713-894-4393
Rtang@neuroeye.com

More Details

Status
Recruiting
Sponsor
Oculis

Study Contact

Chief Development Officer
617-928-5886
info@oculis.com