NCT07453888 Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
| NCT ID | NCT07453888 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Dompé Farmaceutici S.p.A |
| Condition | Non-Arteritic Anterior Ischemic Optic Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 272 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 272 participants in total. It began in 2026-07-01 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Key Inclusion Criteria: 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. Key Exclusion Criteria: 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.
Contact & Investigator
Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)
📞 +39 02 583 831
Frequently Asked Questions
Who can join the NCT07453888 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Non-Arteritic Anterior Ischemic Optic Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07453888 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 272 participants.
Is NCT07453888 currently recruiting?
Yes, NCT07453888 is actively recruiting participants. Visit ClinicalTrials.gov or contact Dompé Farmaceutici S.p.A to inquire about joining.
Where is the NCT07453888 trial being conducted?
This trial is being conducted at Los Angeles, United States, Los Angeles, United States, Newport Beach, United States, Palo Alto, United States and 11 additional locations.
Who is sponsoring the NCT07453888 clinical trial?
NCT07453888 is sponsored by Dompé Farmaceutici S.p.A. The trial plans to enroll 272 participants.