Health TrialsbyHealthPanel

Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research

ConditionOptic Neuritis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-50
SponsorOculis

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Privosegtor

    Drug

    Privosegtor (OCS-05) 3 mg/kg/day IV for 5 treatment days

  • Methylprednisolone

    Drug

    Methylprednisolone 1 g/day IV for 5 treatment days

  • Placebo

    Other intervention

    0.9% sodium chloride (NaCl) solution IV for 5 treatment days

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: PrivosegtorExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Proportion of participants achieving at least 15-letter gain from baseline in low contrast visual acuity (LCVA).

Time frame
3 months

Secondary outcomes

1

Proportion of participants achieving at least 30-letter gain from baseline in low contrast visual acuity (LCVA).

Time frame
3 months
2

Mean change from baseline in low contrast visual acuity (LCVA).

Time frame
3 months
3

Mean change from baseline in the ganglion cell - inner plexiform layer (GCIPL) thickness.

Time frame
3 months
4

Serum neurofilament light chain (sNfL) mean change from baseline.

Time frame
Through month 3

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oculis

Lead sponsor

Source ClinicalTrials.gov
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