Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)

a study on Ischemic Optic Neuropathy Neuropathy

Summary

Eligibility
for people ages 50-80 (full criteria)
Location
at UC Davis UCLA
Dates
study started
study ends around
Principal Investigator
by Peter Quiros (ucla)Yin Allison Liu (ucdavis)

Description

Summary

This is a phase 3, randomized, multicenter, vehicle-controlled, double-masked study to evaluate the efficacy and safety of intranasal cenegermin compared with vehicle control in adult participants with NAION. Approximately 272 participants who meet all eligibility criteria will be randomly assigned in a 1:1 ratio to receive either cenegermin treatment (Group 1) or the vehicle control (Group 2).

Official Title

Randomized, Multicenter, Vehicle-Controlled, Double-Masked Phase 3 Study to Evaluate the Efficacy and Safety of Intranasal Cenegermin (Recombinant Human Nerve Growth Factor [rhNGF]) in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)

Keywords

Non-Arteritic Anterior Ischemic Optic Neuropathy, Acute optic neuropathy, NAION, cenegermin, Optic neuropathy, Intranasal, Ischemic Optic Neuropathy, Optic Nerve Diseases, Vehicle

Eligibility

You can join if…

Open to people ages 50-80

  1. A clinical diagnosis of unilateral NAION in the study eye with symptom onset within 14 days prior to the planned date for first dose administration.
  2. A BCVA score in the study eye of ≥ 15 letters and ≤ 65 letters measured using the ETDRS chart.
  3. Sufficiently clear ocular media and adequate pupil dilation to enable assessment of the optic nerve and retina in both eyes.

You CAN'T join if...

  1. Bilateral NAION or sequential NAION with fellow eye involvement within 6 weeks of study eye involvement.
  2. Clinical evidence of temporal arteritis (giant cell arteritis) signs or symptoms.
  3. Abnormal laboratory findings suggestive of temporal arteritis (giant cell arteritis), in the absence of a known acute cause
  4. Pain with eye movement
  5. Intraocular pressure (IOP) greater than 25 mmHg in the study eye or history of glaucoma in the study eye.
  6. Intermediate age-related macular degeneration (AMD) with subfoveal drusen, exudative AMD, or geographic atrophy in the study eye.

Note: Additional inclusion/exclusion criteria apply, as defined in the protocol.

Locations

  • David Geffen School of Medicine at UCLA - Ophthalmology not yet accepting patients
    Los Angeles California 90095 United States
  • UC Davis Health, Ophthalmology accepting new patients
    Sacramento California 95817 United States
  • California Orbital Consultants accepting new patients
    Newport Beach California 92660 United States
  • Neuro Eye Orbit Institute accepting new patients
    Los Angeles California 90048 United States
  • Stanford Byers Eye Institute accepting new patients
    Palo Alto California 94303 United States

Lead Scientists at University of California Health

  • Peter Quiros (ucla)
    Director, Deans Office-School Of Medicin, Medicine. Authored (or co-authored) 33 research publications
  • Yin Allison Liu (ucdavis)
    Associate Professor, MED: Eye Center, School of Medicine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Dompé Farmaceutici S.p.A
ID
NCT07453888
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 272 study participants
Last Updated
Contact us about this trial