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NCT07453888 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
A Phase 3 study, sponsored by Dompé Farmaceutici S.p.A.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 272
- Enrollment target
NCT07453888: Recruiting Phase 3 study, sponsored by Dompé Farmaceutici S.p.A.
NCT07453888 is a Phase 3 study that is actively recruiting participants, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 272 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07453888, a Phase 3 study, is actively recruiting participants, sponsored by Dompé Farmaceutici S.p.A.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 272 participants
- Enrollment target
Study 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).
Primary Outcome
Improvement in visual acuity defined as a \>=15 letter increase in BCVA using ETDRS chart.
Interventions
- OTHER Vehicle
- DRUG Cenegermin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 272 participants |
| Start Date | 2026-06-30 |
| Est. Completion | 2027-09 |
| Phase | Phase 3 |
What NCT07453888 shows while recruiting
NCT07453888 is an interventional study that assigns participants to a tested intervention. The registered 272 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT07453888 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07453888 about?
NCT07453888 is a clinical study titled "Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)". 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 ...
What is the current status of trial NCT07453888?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 272 participants. The study started on 2026-06-30. Estimated completion is 2027-09.
What interventions are being tested in trial NCT07453888?
The interventions under investigation include: Vehicle (OTHER), Cenegermin (DRUG).
Who is sponsoring clinical trial NCT07453888?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07453888's enrollment target sits among peer trials
272 1214th of 2000 higher than 785 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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