Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07519902

PHASE3

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

Sponsor: Dompé Farmaceutici S.p.A

View on ClinicalTrials.gov

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).

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-06-02

Completion Date

2027-12

Last Updated

2026-07-16

Healthy Volunteers

Conditions

Persistent Corneal Epithelial Defect

Interventions

DRUG

Cenegermin

Cenegermin is administered topically.

OTHER

Vehicle

Vehicle is administered topically.

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. Exclusion Criteria: * 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: 1. Bacterial, fungal, or protozoal infection at screening 2. Active infectious stromal infiltrates or edema at screening 3. Acute anterior uveitis of grade 2 or greater within 30 days of screening 4. Acute intermediate uveitis or posterior uveitis within 30 days of screening 5. 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: 1. 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) 2. Lagophthalmos greater than 2 mm as measured in the clinic 3. Existing diagnosis of nocturnal lagophthalmos or Parkinson's disease 4. Inability to fully close eyelids despite voluntary eyelid closure 5. 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: 1. Severe limbal stem cell deficiency, defined as involvement of more than 270 cumulative degrees or more of limbal stem cell deficiency 2. 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 * 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: 1. Any acute or active severe systemic inflammatory disease (eg, acute systemic Stevens-Johnson Syndrome, acute systemic GVHD, severe systemic Sjogren's, mucous membrane pemphigoid) 2. 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: 1. 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 2. 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

Locations (77)

Azul Vision, INC

Huntington Beach, California, United States

Harvard Eye Associates

Laguna Hills, California, United States

Loma Linda University Adventist Health Sciences Center

Loma Linda, California, United States

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

Los Angeles, California, United States

California Eye Specialists Medical Group, Inc.

Redlands, California, United States

East Coast Institute for Research - Florida Eye Specialists

Jacksonville, Florida, United States

Bascom Palmer Eye Institute, University of Miami School of Medicine

Miami, Florida, United States

University of South Florida

Tampa, Florida, United States

Massachusetts Eye and Ear

Boston, Massachusetts, United States

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

University of Michigan Health - Kellogg Eye Center

Ann Arbor, Michigan, United States

Midwest Vision Research Foundation

Chesterfield, Missouri, United States

NYU Langone Eye Center (Ophthalmology)

New York, New York, United States

Duke Eye Center - Ophthalmology

Durham, North Carolina, United States

Vance Thompson Vision - Sioux Falls

Sioux Falls, South Dakota, United States

Houston Eye Associates (HEA)

Houston, Texas, United States

The Eye Institute of Utah

Salt Lake City, Utah, United States

Virginia Eye Consultants

Norfolk, Virginia, United States

Hospital Italiano de Buenos Aires

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Buenos Aires Macula S.A. - Clinic

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina

Fundacion Zambrano

Buenos Aires, Buenos Aires F.D., Argentina

Centro Oftalmologico Dr Charles SA

Buenos Aires, Buenos Aires F.D., Argentina

Oftar S.R.L.

Mendoza, Argentina

FN Brno - Ocni klinika

Brno, Brno-město, Czechia

Vseobecna fakultni nemocnice v Praze - Ocni klinika

Prague, Praha, Hlavní Mesto, Czechia

CHU Saint Etienne, Hôpital Nord

Saint-Etienne, Auvergne-Rhône-Alpes, France

Centre Hospitalier Regional Universitaire (CHRU) Brest

Brest, Brittany Region, France

Centre Hospitalier Régional Universitaire de Tours

Tours, Indre-et-Loire, France

APHP Hopital Cochin

Paris, France

Fondation Ophtalmologique A. de Rothschild

Paris, France

Universitaetsklinikum Erlangen - Augenklinik

Erlangen, Bavaria, Germany

Johann Wolfgang Goethe-Universitaet Frankfurt - Klinik fuer Augenheilkunde

Frankfurt am Main, Hesse, Germany

Philipps-University Marburg

Marburg, Hesse, Germany

Universitaetsklinikum Koeln - Zentrum fuer Augenheilkunde

Cologne, North Rhine-Westphalia, Germany

Kliniken der Stadt Koeln

Cologne, North Rhine-Westphalia, Germany

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

Düsseldorf, North Rhine-Westphalia, Germany

Universitaetsklinikum des Saarlandes - Augenklinik

Homburg, Saarland, Germany

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

Berlin, Germany

Vididit Kft.

Eger, Heves County, Hungary

Semmelweis Egyetem - Ophthalmology

Budapest, Hungary

Ospedale Santa Maria della Misericordia - Oculistica

Perugia, S. Andrea Delle Fratte, Perugia, Italy

Azienda Ospedaliero Universitaria Careggi - Oculistica

Florence, Italy

Oculistica

Milan, Italy

ASST Fatebenefratelli Sacco - Oculistica Sacco

Milan, Italy

Fondazione IRCCS Policlinico San Matteo - Oculistica

Pavia, Italy

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

Roma, Italy

Ehime University Hospital

Tōon, Ehime, Japan

The University of Tokyo Hospital

Bunkyō City, Tôkyô [Tokyo], Japan

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

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

Asociacion para Evitar la Ceguera en Mexico

Mexico City, Mexico City, Mexico

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

Monterrey, Nuevo León, Mexico

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

Mexico, Puebla, Mexico

Amsterdam UMC - Ophthalmology

Amsterdam, North Holland, Netherlands

The Rotterdam Eye Hospital - unspecified

Rotterdam, South Holland, Netherlands

Universitair Medisch Centrum Utrecht - Ophthalmology

Utrecht, Netherlands

OCHO Lublin Gabinety Okulistyczne

Lublin, Lublin Voivodeship, Poland

Samodzielny Publiczny Kliniczny Szpital Okulistyczny

Warsaw, Masovian Voivodeship, Poland

Gabinet Okulistyczny Prof Edward Wylegala

Katowice, Silesian Voivodeship, Poland

Yonsei University Wonju Severance Christian Hospital

Wŏnju, Gang'weondo [Kang-won-do], South Korea

Chonnam National University Hospital - Ophthalmology

Gwangju, Gwangju Gwang'Yeogsi [Kwangju-Kwangyokshi], South Korea

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

Bucheon-si, Gyeonggido [Kyonggi-do], South Korea

Korea University Anam Hospital

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea

Soon Chun Hyang University Hospital Seoul

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea

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

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea

Asan Medical Center - Asan Cancer Center

Seoul, South Korea

Centro de Ojos de la Coruna

A Coruña, A Coruna, Spain

Hospital La Arruzafa - Instituto de OftalmologÃ-a La Arruzafa

Cardona, Andalusia, Spain

Hospital Universitari Germans Trias i Pujol (HUGTP)

Badalona, Barcelona, Spain

I. Microcirugía Ocular - IMO - Oftalmología

Barcelona, Spain

Hospital Regional Universitario de Malaga

Málaga, Spain

Fundación de Oftalmología Médica de la Comunitat Valenciana

Valencia, Spain

IOBA Instituto de Oftalmología Biologica Aplicada

Valladolid, Spain

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

Bristol, Bristol, City of, United Kingdom

Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital

Liverpool, England, United Kingdom

Moorfields eye Hospital

London, York, United Kingdom

Nottingham University Hospitals NHS Trust - Queen's Medical Centre

Nottingham, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (77)