Cenegermin for Corneal Ulcer

Not yet recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Dompé Farmaceutici S.p.A

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a phase 3, randomized, multicenter, double-masked, parallel group, vehicle-controlled prospective clinical trial to evaluate the safety and efficacy of cenegermin in inducing complete epithelial healing in participants with PCED. The primary objective is the evaluation of complete epithelial healing after 4 weeks of treatment. The study is comprised of 3 periods: an 8-week initial treatment period (Day 1 to Week 8), an 8-week extension treatment period (Week 9 to Week 16), and a 24-week follow-up period (Week 17 to Week 40).

Are You a Good Fit for This Trial?

This trial is for adults with persistent corneal epithelial defects (PCED) at least 1 mm in size, lasting at least 14 days and not healing despite standard treatments. Participants must have stable eye medication use if taking any.

Inclusion Criteria

I am at least 18 years old (or 19 in South Korea).

I have used the same eye medication (not for PCED) for at least 30 days.

I am already using antibiotic eye drops up to 4 times daily in the study eye.

Exclusion Criteria

I have no vision or do not have my other eye.

I do not have any active eye infections or inflammation in the study eye.

I have a corneal defect with significant thinning or an infiltrate.

What Are the Treatments Tested in This Trial?

Interventions

• Cenegermin

Trial Overview

The study compares cenegermin eye drops to placebo (vehicle) drops to see which helps heal the surface of the eye in people with PCED. Participants are randomly assigned to one group and neither they nor their doctors know which treatment they're getting.

How Is the Trial Designed?

Group I: Cenegermin Experimental Treatment 1 Intervention

Participants will be randomized to receive cenegermin ophthalmic solution in the study eye.

Group II: Vehicle Placebo Group 1 Intervention

Participants will be randomized to receive vehicle ophthalmic solution in the study eye.

Who Is Running the Clinical Trial?

Dompé Farmaceutici S.p.A

Lead Sponsor

Trials

53

Recruited

4,400+

Founded

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