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

Conditions

• Non-Arteritic Anterior Ischemic Optic Neuropathy

Eligibility Criteria

Sex

ALL

Age

50 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Cenegermin — DRUG
  Cenegermin is administered intranasally.
• Vehicle — OTHER
  Vehicle spray is administered intranasally.

Study Details

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).

Key Dates

First listed

Mar 6, 2026

Start date

Jul 1, 2026

Status verified

Sep 2026

Primary completion

Sep 30, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

272 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cenegermin
  Participants will be administered with cenegermin spray in each nostril.
• Placebo Comparator: Vehicle
  Participants will be administered with vehicle spray in each nostril.

Primary Outcome Measure

Achievement of ≥ 15 letter increase in Best Corrected Visual Acuity (BCVA), assessed in each individual participant, measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart [ Time Frame: Baseline to Week 24 ]

Central Contacts

• Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)
  +39 02 583 831

Locations (22)

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