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Persistent Corneal Epithelial DefectPhase 3NCT07519902

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

A Phase 3 study testing Cenegermin in people with Persistent Corneal Epithelial Defect, run by Dompé Farmaceutici S.p.A at 77 sites in 14 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Persistent Corneal Epithelial Defect
What is being tested?
Cenegermin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
77 sitesin 14 countries
Study dates
2 Jun 2026to Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 39Show fewer
  • 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:
  • 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
  • Use of any systemic investigational product, ocular investigational product in the study eye, radiation of the head or neck, or systemic chemotherapy within 90 days, or planned to occur during the study period c. Devices:
  • Use of contact lens (including therapeutic contact lens) within 7 days, or planned use of contact lens during the study period, in the study eye
  • Anticipated need for punctal occlusion in the study eye during the study period. Participants with punctal occlusion or punctal plugs inserted prior to the study are eligible for enrolment provided that the punctual occlusion is maintained throughout the study.
  • Presence of acute severe systemic disease as follows:
  • Any acute or active severe systemic inflammatory disease (eg, acute systemic Stevens-Johnson Syndrome, acute systemic GVHD, severe systemic Sjogren's, mucous membrane pemphigoid)
  • Presence of any systemic disease that may affect ability to participate in the clinical study according to the clinical judgment of the investigator
  • Recent surgery or amniotic membrane therapy as follows:
  • Recent major surgical procedure for the treatment of PCED (eg, conjunctival flap, complete tarsorrhaphy, superficial keratectomy for epithelial defect revision, etc) within 14 days of randomization
  • Presence of amniotic membrane from AMT for ocular surface indication if not dissolved within area of PCED within 14 days of randomization. Examples include:
  • Sutured AMT
  • Self-retaining AMT
  • Contact lens combined with AMT
  • Other AMT treatment for the ocular surface c. Partial tarsorrhaphy (temporary or permanent) placed within 14 days of randomization. If a participant is enrolled with partial tarsorrhaphy placed more than 14 days prior to randomization, then the tarsorrhaphy must not be removed for the entire duration of the study.
  • Note: Additional exclusion criteria apply, as defined in the protocol

Trial locations and contacts

77 sites in 14 countries. Contact the study team or a site near you to ask about taking part.

Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI) contact

+39 02 583 831

77 sites in 14 countries

United States18 sites, 18 recruiting

  • University of Michigan Health - Kellogg Eye Center

    Ann Arbor, Michigan, 48105

    Recruiting

  • Massachusetts Eye and Ear

    Boston, Massachusetts, 02114

    Recruiting

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

    Recruiting

  • Midwest Vision Research Foundation

    Chesterfield, Missouri, 63017

    Recruiting

  • Duke Eye Center - Ophthalmology

    Durham, North Carolina, 27705

    Recruiting

  • Houston Eye Associates (HEA)

    Houston, Texas, 77030

    Recruiting

  • Azul Vision, INC

    Huntington Beach, California, 92647

    Recruiting

  • East Coast Institute for Research - Florida Eye Specialists

    Jacksonville, Florida, 32207

    Recruiting

  • Harvard Eye Associates

    Laguna Hills, California, 92653

    Recruiting

  • Loma Linda University Adventist Health Sciences Center

    Loma Linda, California, 92354

    Not yet recruiting

  • UCLA - Jules Stein Eye Institute (JSEI) - Diabetic Eye Dise

    Los Angeles, California, 90095

    Not yet recruiting

  • Bascom Palmer Eye Institute, University of Miami School of Medicine

    Miami, Florida, 33136

    Recruiting

  • NYU Langone Eye Center (Ophthalmology)

    New York, New York, 10017

    Recruiting

  • Virginia Eye Consultants

    Norfolk, Virginia, 23502

    Recruiting

  • California Eye Specialists Medical Group, Inc.

    Redlands, California, 92373

    Recruiting

  • The Eye Institute of Utah

    Salt Lake City, Utah, 84107

    Recruiting

  • Vance Thompson Vision - Sioux Falls

    Sioux Falls, South Dakota, 57108

    Recruiting

  • University of South Florida

    Tampa, Florida, 33620

    Recruiting

Other trials in United States

Spain9 sites, 9 recruiting

  • Centro de Ojos de la Coruna

    A Coruña, A Coruna, 15006

    Recruiting

  • Hospital Universitari Germans Trias i Pujol (HUGTP)

    Badalona, Barcelona, 8916

    Recruiting

  • I. Microcirugía Ocular - IMO - Oftalmología

    Barcelona, 8035

    Recruiting

  • Hospital La Arruzafa - Instituto de OftalmologÃ-a La Arruzafa

    Cardona, Andalusia, 14012

    Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

    Not yet recruiting

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

    Recruiting

  • Miranza Virgen de Lujan

    Seville, 41011

    Not yet recruiting

  • Fundación de Oftalmología Médica de la Comunitat Valenciana

    Valencia, 46015

    Recruiting

  • IOBA Instituto de Oftalmología Biologica Aplicada

    Valladolid, 47011

    Recruiting

Other trials in Spain

Germany8 sites, 8 recruiting

  • Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)

    Berlin, 13353

    Recruiting

  • Universitaetsklinikum Koeln - Zentrum fuer Augenheilkunde

    Cologne, North Rhine-Westphalia, 50937

    Not yet recruiting

  • Kliniken der Stadt Koeln

    Cologne, North Rhine-Westphalia, 51109

    Not yet recruiting

  • Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf (UKD)

    Düsseldorf, North Rhine-Westphalia, 40225

    Not yet recruiting

  • Universitaetsklinikum Erlangen - Augenklinik

    Erlangen, Bavaria, 91054

    Recruiting

  • Johann Wolfgang Goethe-Universitaet Frankfurt - Klinik fuer Augenheilkunde

    Frankfurt am Main, Hesse, 60596

    Recruiting

  • Universitaetsklinikum des Saarlandes - Augenklinik

    Homburg, Saarland, 66421

    Recruiting

  • Philipps-University Marburg

    Marburg, Hesse, 35043

    Not yet recruiting

Other trials in Germany

Argentina7 sites, 7 recruiting

  • Fundacion Zambrano

    Buenos Aires, Buenos Aires F.D., C1023AAQ

    Not yet recruiting

  • Centro Oftalmologico Dr Charles SA

    Buenos Aires, Buenos Aires F.D., C1121

    Not yet recruiting

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma de Buenos Aire, Buenos Aires, C1199ABB

    Not yet recruiting

  • Buenos Aires Macula S.A. - Clinic

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1061AAE

    Not yet recruiting

  • Oftar S.R.L.

    Mendoza, M5500

    Not yet recruiting

  • Hospital Universitario Austral

    Pilar, Buenos Aires, B1629ODT

    Not yet recruiting

  • Centro Oftalmológico Salud Ocular

    Rio Negro, Río Negro Province, 8332

    Not yet recruiting

Other trials in Argentina

South Korea7 sites, 7 recruiting

  • The Catholic University of Korea, Bucheon St.Mary's Hospital

    Bucheon-si, Gyeonggido [Kyonggi-do], 14647

    Not yet recruiting

  • Chonnam National University Hospital - Ophthalmology

    Gwangju, Gwangju Gwang'Yeogsi [Kwangju-Kwangyokshi], 61469

    Recruiting

  • Korea University Anam Hospital

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 2841

    Recruiting

  • Soon Chun Hyang University Hospital Seoul

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 4401

    Recruiting

  • The Catholic University of Korea, Seoul St. Mary's Hospital - Ophthalmology

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 6591

    Recruiting

  • Asan Medical Center - Asan Cancer Center

    Seoul, 5505

    Recruiting

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, Gang'weondo [Kang-won-do], 26426

    Recruiting

Other trials in South Korea

Italy6 sites, 6 recruiting

  • Azienda Ospedaliero Universitaria Careggi - Oculistica

    Florence, 50134

    Recruiting

  • Oculistica

    Milan, 20132

    Recruiting

  • ASST Fatebenefratelli Sacco - Oculistica Sacco

    Milan, 20157

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo - Oculistica

    Pavia, 27100

    Not yet recruiting

  • Ospedale Santa Maria della Misericordia - Oculistica

    Perugia, S. Andrea Delle Fratte, Perugia, 6129

    Not yet recruiting

  • Fondazione G.B. Bietti Per Lo Studio E La Ricerca In Oftalmologia - Unita' Segmento Anteriore

    Roma, 184

    Recruiting

Other trials in Italy

France5 sites, 5 recruiting

  • Centre Hospitalier Regional Universitaire (CHRU) Brest

    Brest, Brittany Region, 29200

    Recruiting

  • APHP Hopital Cochin

    Paris, 75014

    Not yet recruiting

  • Fondation Ophtalmologique A. de Rothschild

    Paris, 75019

    Recruiting

  • CHU Saint Etienne, Hôpital Nord

    Saint-Etienne, Auvergne-Rhône-Alpes, 42702

    Recruiting

  • Centre Hospitalier Régional Universitaire de Tours

    Tours, Indre-et-Loire, 37000

    Not yet recruiting

Other trials in France

Mexico4 sites, 4 recruiting

  • Centro Oftalmologico de Tijuana, S.A de C.V.

    Col. Buenos Aires NorteTijuana, Estado de Baja California, 22330

    Not yet recruiting

  • Instituto de Oftalmologia ''Fundacion de Asistencia Privada Conde de Valenciana IAP - Ophthalmology

    Mexico, Puebla, 6080

    Not yet recruiting

  • Asociacion para Evitar la Ceguera en Mexico

    Mexico City, Mexico City, 4030

    Not yet recruiting

  • Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 64460

    Not yet recruiting

Other trials in Mexico

United Kingdom4 sites, 4 recruiting

  • University Hospitals Bristol and Weston NHS Foundation Trust - Bristol Eye Hospital

    Bristol, Bristol, City of, BS1 2LX

    Recruiting

  • Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital

    Liverpool, England, L78XP

    Recruiting

  • Moorfields eye Hospital

    London, York, EC1V 2PD

    Recruiting

  • Nottingham University Hospitals NHS Trust - Queen's Medical Centre

    Nottingham, NG7 2UH

    Not yet recruiting

Other trials in United Kingdom

Poland3 sites, 3 recruiting

  • Gabinet Okulistyczny Prof Edward Wylegala

    Katowice, Silesian Voivodeship, 40-594

    Recruiting

  • OCHO Lublin Gabinety Okulistyczne

    Lublin, Lublin Voivodeship, 20-704

    Recruiting

  • Samodzielny Publiczny Kliniczny Szpital Okulistyczny

    Warsaw, Masovian Voivodeship, 03-709

    Recruiting

Other trials in Poland

Japan2 sites, 2 recruiting

  • The University of Tokyo Hospital

    Bunkyō City, Tôkyô [Tokyo], 113-8655

    Recruiting

  • Ehime University Hospital

    Tōon, Ehime, 791-0295

    Recruiting

Other trials in Japan

Netherlands2 sites, 2 recruiting

  • Amsterdam UMC - Ophthalmology

    Amsterdam, North Holland, 1081 HZ

    Recruiting

  • Universitair Medisch Centrum Utrecht - Ophthalmology

    Utrecht, 3584 CX

    Not yet recruiting

Other trials in Netherlands

Czechia1 site, 1 recruiting

  • Vseobecna fakultni nemocnice v Praze - Ocni klinika

    Prague, Praha, Hlavní Mesto, 128 08

    Recruiting

Other trials in Czechia

Hungary1 site, 1 recruiting

  • Semmelweis Egyetem - Ophthalmology

    Budapest, H-1089

    Recruiting

Other trials in Hungary

About this study

Official title: Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Recombinant Human Nerve Growth Factor Eye Drop Solution in Participants With Persistent Corneal Epithelial Defect (PCED)

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).

Being tested
Cenegermin, Vehicle
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
Medical subject headings
Conjunctivitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CenegerminDrug

    Cenegermin is administered topically.

  • VehicleOther

    Vehicle is administered topically.

Study groups in NCT07519902
Study groupRoleWhat they receive
CenegerminExperimentalParticipants will be randomized to receive cenegermin ophthalmic solution in the study eye.
Receives: Drug: Cenegermin
VehiclePlacebo comparatorParticipants will be randomized to receive vehicle ophthalmic solution in the study eye.
Receives: Other: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of responders achieving complete epithelial healing of the cornea at Week 4 and maintained at Week 8

    Measured: At Weeks 4 and 8

Secondary outcomes (6)

  1. Percentage change from baseline in maximum diameter of PCED at week 4

    Measured: Baseline and Week 4

  2. Percentage change from baseline in maximum diameter of PCED at week 8

    Measured: Baseline and Week 8

  3. Proportion of responders achieving complete epithelial healing of the cornea at Week 8 and maintained at Week 10

    Measured: At Weeks 8 and 10

  4. Linear change from baseline in maximum diameter of the PCED at week 4

    Measured: Baseline and Week 4

  5. Number of participants reporting Treatment Emergent Adverse Events (TEAEs)

    Measured: Through Week 40

  6. Number of participants discontinuing the study due to intolerability

    Measured: Through Week 40

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2026
  2. Study start2 Jun 2026
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07519902
Sponsor's protocol ID
NGF-PCED-301
Other IDs
2025-523443-35-00, 2025
Status last verified
Oct 2026
First submitted
30 Mar 2026
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cenegermin in people with Persistent Corneal Epithelial Defect, run by Dompé Farmaceutici S.p.A at 77 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States, Spain, Germany, Argentina, South Korea and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI) (+39 02 583 831), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of responders achieving complete epithelial healing of the cornea at Week 4 and maintained at Week 8 (time frame: At Weeks 4 and 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07519902.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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