An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED

Recruiting now · Phase 3

Conditions studied: Persistent Corneal Epithelial Defect

In brief

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).

Key facts

Study ID

NCT07519902

Run by

Dompé Farmaceutici S.p.A

People needed

150

Starts

2026-06-02

Expected to finish

2027-12-01

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• PCED ≥ 1.0 mm in greatest diameter
• 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.

You may not qualify if…

• Contralateral eye with vision of no light perception or anatomic absence of contralateral eye.
• Active ocular infection or inflammation in the study eye as follows:
• Bacterial, fungal, or protozoal infection at screening
• Active infectious stromal infiltrates or edema at screening
• Acute anterior uveitis of grade 2 or greater within 30 days of screening
• Acute intermediate uveitis or posterior uveitis within 30 days of screening
• Acute inflammation of the sclera or conjunctiva if it is not associated with the PCED
• Corneal epithelial defect associated with stromal thinning greater than 30% (estimated on clinical slit lamp exam) or if associated with stromal infiltrate (corneal haze is acceptable), in the study eye.
• Severe eyelid disease in the study eye, such as:
• Mechanical eyelid abnormalities that have direct contact with the PCED (e.g., trichiasis, severe entropion with lid margin keratinization, etc, if in direct contact with the PCED)
• Lagophthalmos greater than 2 mm as measured in the clinic
• Existing diagnosis of nocturnal lagophthalmos or Parkinson's disease
• Inability to fully close eyelids despite voluntary eyelid closure
• Severe ectropion with abnormal eyelid-globe congruity (e.g., the lower eyelid does not come into contact with the globe due to severe ectropion)
• Severe end-stage ocular surface disease in the study eye, including but not limited to:
• Severe limbal stem cell deficiency, defined as involvement of more than 270 cumulative degrees or more of limbal stem cell deficiency
• Keratinization of the bulbar conjunctiva or lid margin
• Use of the following medications and devices within the indicated time window prior to randomization:
• a. Local medications in study eye:
• Any prior use of cenegermin
• Blood-derived eye drops (autologous serum) or other ocular surface re-epithelizing agents, topical anesthetic use by the participant outside of the clinical exam setting, topical insulin, or topical steroids (unless associated with post-operative treatment regimen) within 7 days
• Botox (botulinum toxin) injections for pharmacologic tarsorrhaphy within 90 days b. Systemic medications:
• High-dose systemic corticosteroids (greater than 0.5 mg/kg/day) within 30 days
• Any changes in oral medication regimen intended for the treatment of the ocular surface (eg, oral doxycycline) within 30 days, or planned changes during the study period
• Systemic opioid use within 30 days

Where it is running

• Moorfields eye Hospital — London, York, United Kingdom (enrolling)
• University of South Florida — Tampa, Florida, United States (enrolling)
• Centro de Ojos de la Coruna — A Coruña, A Coruna, Spain (enrolling)
• Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital — Liverpool, England, United Kingdom (enrolling)
• California Eye Specialists Medical Group, Inc. — Redlands, California, United States (enrolling)
• Bascom Palmer Eye Institute, University of Miami School of Medicine — Miami, Florida, United States (enrolling)
• OCHO Lublin Gabinety Okulistyczne — Lublin, Lublin Voivodeship, Poland (enrolling)
• Gabinet Okulistyczny Prof Edward Wylegala — Katowice, Silesian Voivodeship, Poland (enrolling)
• I. Microcirugía Ocular - IMO - Oftalmología — Barcelona, Spain (enrolling)
• University Hospitals Bristol and Weston NHS Foundation Trust - Bristol Eye Hospital — Bristol, Bristol, City of, United Kingdom (enrolling)
• Harvard Eye Associates — Laguna Hills, California, United States (enrolling)
• Midwest Vision Research Foundation — Chesterfield, Missouri, United States (enrolling)
• Houston Eye Associates (HEA) — Houston, Texas, United States (enrolling)
• East Coast Institute for Research - Florida Eye Specialists — Jacksonville, Florida, United States (enrolling)
• The Eye Institute of Utah — Salt Lake City, Utah, United States (enrolling)
• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States (enrolling)
• Virginia Eye Consultants — Norfolk, Virginia, United States (enrolling)
• Samodzielny Publiczny Kliniczny Szpital Okulistyczny — Warsaw, Masovian Voivodeship, Poland (enrolling)
• Hospital La Arruzafa - Instituto de OftalmologÃ-a La Arruzafa — Cardona, Andalusia, Spain (enrolling)
• Hospital Universitari Germans Trias i Pujol (HUGTP) — Badalona, Barcelona, Spain (enrolling)
• Fundación de Oftalmología Médica de la Comunitat Valenciana — Valencia, Spain (enrolling)
• IOBA Instituto de Oftalmología Biologica Aplicada — Valladolid, Spain (enrolling)
• Vance Thompson Vision - Sioux Falls — Sioux Falls, South Dakota, United States (enrolling)
• Azul Vision, INC — Huntington Beach, California, United States (enrolling)
• Massachusetts Eye and Ear — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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