Persistent Corneal Epithelial Defect
Conditions
Keywords
PCED, Recombinant Human Nerve Growth Factor, NGF, Ocular graft versus host disease, Neurotrophic keratitis, Vernal keratoconjunctivitis, Tropomyosin receptor kinase A, Low-affinity neurotrophic receptor, Persistent Corneal Epithelial Defect
Brief summary
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).
Interventions
DRUGCenegermin
Cenegermin is administered topically.
OTHERVehicle
Vehicle is administered topically.
Sponsors
Dompé Farmaceutici S.p.A
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The Sponsor will also be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women aged 18 years or above (in South Korea, 19 years or above). * Participants with PCED in the study eye with the following characteristics: 1. PCED ≥ 1.0 mm in greatest diameter 2. PCED of at least 14 days duration, refractory to 1 or more conventional nonsurgical treatments (ocular lubricants, discontinuation of preserved topical drops and medications, bandage contact lens) showing no clinical resolution. * Use of most topical ophthalmic medications (including glaucoma medications) indicated for ocular conditions other than PCED is permitted in the study eye, if the participant has been on a stable dose for at least 30 days and does not expect to have change in dosing regimen throughout the entire duration of the study. Please see
Exclusion criteria
list for exceptions. * Use of prophylactic topical antibiotics up to 4 times per day in the study eye is permitted if the participant is already receiving them prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of responders achieving complete epithelial healing of the cornea at Week 4 and maintained at Week 8 | At Weeks 4 and 8 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in maximum diameter of PCED at week 4 | Baseline and Week 4 |
| Percentage change from baseline in maximum diameter of PCED at week 8 | Baseline and Week 8 |
| Proportion of responders achieving complete epithelial healing of the cornea at Week 8 and maintained at Week 10 | At Weeks 8 and 10 |
| Linear change from baseline in maximum diameter of the PCED at week 4 | Baseline and Week 4 |
| Number of participants reporting Treatment Emergent Adverse Events (TEAEs) | Through Week 40 |
| Number of participants discontinuing the study due to intolerability | Through Week 40 |
Countries
Argentina, Czechia, France, Germany, Hungary, Italy, Japan, Mexico, Netherlands, Poland, South Korea, Spain, United Kingdom, United States
Contacts
CONTACTDompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)
Outcome results
None listed