An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
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)
2 other identifiers
interventional
150
14 countries
77
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2026
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2026
CompletedFirst Posted
Study publicly available on registry
April 9, 2026
CompletedStudy Start
First participant enrolled
June 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
July 16, 2026
July 1, 2026
1.5 years
March 30, 2026
July 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of responders achieving complete epithelial healing of the cornea at Week 4 and maintained at Week 8
At Weeks 4 and 8
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Cenegermin
EXPERIMENTALParticipants will be randomized to receive cenegermin ophthalmic solution in the study eye.
Vehicle
PLACEBO COMPARATORParticipants will be randomized to receive vehicle ophthalmic solution in the study eye.
Interventions
Eligibility Criteria
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.
You may not qualify if:
- 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.
- 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)
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (77)
Azul Vision, INC
Huntington Beach, California, 92647, United States
Harvard Eye Associates
Laguna Hills, California, 92653, United States
Loma Linda University Adventist Health Sciences Center
Loma Linda, California, 92354, United States
UCLA - Jules Stein Eye Institute (JSEI) - Diabetic Eye Dise
Los Angeles, California, 90095, United States
California Eye Specialists Medical Group, Inc.
Redlands, California, 92373, United States
East Coast Institute for Research - Florida Eye Specialists
Jacksonville, Florida, 32207, United States
Bascom Palmer Eye Institute, University of Miami School of Medicine
Miami, Florida, 33136, United States
University of South Florida
Tampa, Florida, 33620, United States
Massachusetts Eye and Ear
Boston, Massachusetts, 02114, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
University of Michigan Health - Kellogg Eye Center
Ann Arbor, Michigan, 48105, United States
Midwest Vision Research Foundation
Chesterfield, Missouri, 63017, United States
NYU Langone Eye Center (Ophthalmology)
New York, New York, 10017, United States
Duke Eye Center - Ophthalmology
Durham, North Carolina, 27705, United States
Vance Thompson Vision - Sioux Falls
Sioux Falls, South Dakota, 57108, United States
Houston Eye Associates (HEA)
Houston, Texas, 77030, United States
The Eye Institute of Utah
Salt Lake City, Utah, 84107, United States
Virginia Eye Consultants
Norfolk, Virginia, 23502, United States
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1199ABB, Argentina
Buenos Aires Macula S.A. - Clinic
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1061AAE, Argentina
Hospital Universitario Austral
Pilar, Buenos Aires, B1629ODT, Argentina
Fundacion Zambrano
Buenos Aires, Buenos Aires F.D., C1023AAQ, Argentina
Centro Oftalmologico Dr Charles SA
Buenos Aires, Buenos Aires F.D., C1121, Argentina
Oftar S.R.L.
Mendoza, M5500, Argentina
FN Brno - Ocni klinika
Brno, Brno-město, 625 00, Czechia
Vseobecna fakultni nemocnice v Praze - Ocni klinika
Prague, Praha, Hlavní Mesto, 128 08, Czechia
CHU Saint Etienne, Hôpital Nord
Saint-Etienne, Auvergne-Rhône-Alpes, 42702, France
Centre Hospitalier Regional Universitaire (CHRU) Brest
Brest, Brittany Region, 29200, France
Centre Hospitalier Régional Universitaire de Tours
Tours, Indre-et-Loire, 37000, France
APHP Hopital Cochin
Paris, 75014, France
Fondation Ophtalmologique A. de Rothschild
Paris, 75019, France
Universitaetsklinikum Erlangen - Augenklinik
Erlangen, Bavaria, 91054, Germany
Johann Wolfgang Goethe-Universitaet Frankfurt - Klinik fuer Augenheilkunde
Frankfurt am Main, Hesse, 60596, Germany
Philipps-University Marburg
Marburg, Hesse, 35043, Germany
Universitaetsklinikum Koeln - Zentrum fuer Augenheilkunde
Cologne, North Rhine-Westphalia, 50937, Germany
Kliniken der Stadt Koeln
Cologne, North Rhine-Westphalia, 51109, Germany
Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf (UKD)
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Universitaetsklinikum des Saarlandes - Augenklinik
Homburg, Saarland, 66421, Germany
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
Berlin, 13353, Germany
Vididit Kft.
Eger, Heves County, 3300, Hungary
Semmelweis Egyetem - Ophthalmology
Budapest, H-1089, Hungary
Ospedale Santa Maria della Misericordia - Oculistica
Perugia, S. Andrea Delle Fratte, Perugia, 6129, Italy
Azienda Ospedaliero Universitaria Careggi - Oculistica
Florence, 50134, Italy
Oculistica
Milan, 20132, Italy
ASST Fatebenefratelli Sacco - Oculistica Sacco
Milan, 20157, Italy
Fondazione IRCCS Policlinico San Matteo - Oculistica
Pavia, 27100, Italy
Fondazione G.B. Bietti Per Lo Studio E La Ricerca In Oftalmologia - Unita' Segmento Anteriore
Roma, 184, Italy
Ehime University Hospital
Tōon, Ehime, 791-0295, Japan
The University of Tokyo Hospital
Bunkyō City, Tôkyô [Tokyo], 113-8655, Japan
Centro Oftalmologico de Tijuana, S.A de C.V.
Col. Buenos Aires NorteTijuana, Estado de Baja California, 22330, Mexico
Asociacion para Evitar la Ceguera en Mexico
Mexico City, Mexico City, 4030, Mexico
Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 64460, Mexico
Instituto de Oftalmologia ''Fundacion de Asistencia Privada Conde de Valenciana IAP - Ophthalmology
Mexico, Puebla, 6080, Mexico
Amsterdam UMC - Ophthalmology
Amsterdam, North Holland, 1081 HZ, Netherlands
The Rotterdam Eye Hospital - unspecified
Rotterdam, South Holland, 3011 BH, Netherlands
Universitair Medisch Centrum Utrecht - Ophthalmology
Utrecht, 3584 CX, Netherlands
OCHO Lublin Gabinety Okulistyczne
Lublin, Lublin Voivodeship, 20-704, Poland
Samodzielny Publiczny Kliniczny Szpital Okulistyczny
Warsaw, Masovian Voivodeship, 03-709, Poland
Gabinet Okulistyczny Prof Edward Wylegala
Katowice, Silesian Voivodeship, 40-594, Poland
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gang'weondo [Kang-won-do], 26426, South Korea
Chonnam National University Hospital - Ophthalmology
Gwangju, Gwangju Gwang'Yeogsi [Kwangju-Kwangyokshi], 61469, South Korea
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon-si, Gyeonggido [Kyonggi-do], 14647, South Korea
Korea University Anam Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 2841, South Korea
Soon Chun Hyang University Hospital Seoul
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 4401, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital - Ophthalmology
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 6591, South Korea
Asan Medical Center - Asan Cancer Center
Seoul, 5505, South Korea
Centro de Ojos de la Coruna
A Coruña, A Coruna, 15006, Spain
Hospital La Arruzafa - Instituto de OftalmologÃ-a La Arruzafa
Cardona, Andalusia, 14012, Spain
Hospital Universitari Germans Trias i Pujol (HUGTP)
Badalona, Barcelona, 8916, Spain
I. Microcirugía Ocular - IMO - Oftalmología
Barcelona, 8035, Spain
Hospital Regional Universitario de Malaga
Málaga, 29010, Spain
Fundación de Oftalmología Médica de la Comunitat Valenciana
Valencia, 46015, Spain
IOBA Instituto de Oftalmología Biologica Aplicada
Valladolid, 47011, Spain
University Hospitals Bristol and Weston NHS Foundation Trust - Bristol Eye Hospital
Bristol, Bristol, City of, BS1 2LX, United Kingdom
Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital
Liverpool, England, L78XP, United Kingdom
Moorfields eye Hospital
London, York, EC1V 2PD, United Kingdom
Nottingham University Hospitals NHS Trust - Queen's Medical Centre
Nottingham, NG7 2UH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- The Sponsor will also be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2026
First Posted
April 9, 2026
Study Start
June 2, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
July 16, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share