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

July 15, 2026 updated by: Dompé Farmaceutici S.p.A

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)
  • Phone Number: +39 02 583 831

Study Locations

  • Argentina
      • Mendoza, Argentina, M5500
        • Not yet recruiting
        • Oftar S.R.L.
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1199ABB
        • Not yet recruiting
        • Hospital Italiano de Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1061AAE
        • Not yet recruiting
        • Buenos Aires Macula S.A. - Clinic
      • Pilar, Buenos Aires, Argentina, B1629ODT
        • Not yet recruiting
        • Hospital Universitario Austral
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1023AAQ
        • Not yet recruiting
        • Fundacion Zambrano
      • Buenos Aires, Buenos Aires F.D., Argentina, C1121
        • Not yet recruiting
        • Centro Oftalmologico Dr Charles SA
  • Czechia
    • Brno-město
      • Brno, Brno-město, Czechia, 625 00
        • Not yet recruiting
        • FN Brno - Ocni klinika
    • Praha, Hlavní Mesto
      • Prague, Praha, Hlavní Mesto, Czechia, 128 08
        • Not yet recruiting
        • Vseobecna fakultni nemocnice v Praze - Ocni klinika
  • France
      • Paris, France, 75014
        • Not yet recruiting
        • APHP Hopital Cochin
      • Paris, France, 75019
        • Not yet recruiting
        • Fondation Ophtalmologique A. de Rothschild
    • Auvergne-Rhône-Alpes
      • Saint-Etienne, Auvergne-Rhône-Alpes, France, 42702
        • Not yet recruiting
        • CHU Saint Etienne, Hôpital Nord
    • Brittany Region
      • Brest, Brittany Region, France, 29200
        • Not yet recruiting
        • Centre Hospitalier Regional Universitaire (CHRU) Brest
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37000
        • Not yet recruiting
        • Centre Hospitalier Regional Universitaire de Tours
  • Germany
      • Berlin, Germany, 13353
        • Not yet recruiting
        • Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Not yet recruiting
        • Universitaetsklinikum Erlangen - Augenklinik
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60596
        • Not yet recruiting
        • Johann Wolfgang Goethe-Universitaet Frankfurt - Klinik fuer Augenheilkunde
      • Marburg, Hesse, Germany, 35043
        • Not yet recruiting
        • Philipps-University Marburg
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Not yet recruiting
        • Universitaetsklinikum Koeln - Zentrum fuer Augenheilkunde
      • Cologne, North Rhine-Westphalia, Germany, 51109
        • Not yet recruiting
        • Kliniken der Stadt Koeln
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Not yet recruiting
        • Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf (UKD)
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • Not yet recruiting
        • Universitaetsklinikum des Saarlandes - Augenklinik
  • Hungary
      • Budapest, Hungary, H-1089
        • Not yet recruiting
        • Semmelweis Egyetem - Ophthalmology
    • Heves County
      • Eger, Heves County, Hungary, 3300
        • Not yet recruiting
        • Vididit Kft.
  • Italy
      • Florence, Italy, 50134
        • Not yet recruiting
        • Azienda Ospedaliero Universitaria Careggi - Oculistica
      • Milan, Italy, 20132
        • Not yet recruiting
        • Oculistica
      • Milan, Italy, 20157
        • Not yet recruiting
        • ASST Fatebenefratelli Sacco - Oculistica Sacco
      • Pavia, Italy, 27100
        • Not yet recruiting
        • Fondazione IRCCS Policlinico San Matteo - Oculistica
      • Roma, Italy, 184
        • Not yet recruiting
        • Fondazione G.B. Bietti Per Lo Studio E La Ricerca In Oftalmologia - Unita' Segmento Anteriore
    • Perugia
      • Perugia, S. Andrea Delle Fratte, Perugia, Italy, 6129
        • Not yet recruiting
        • Ospedale Santa Maria della Misericordia - Oculistica
  • Japan
    • Ehime
      • Tōon, Ehime, Japan, 791-0295
        • Not yet recruiting
        • Ehime University Hospital
    • Tôkyô [Tokyo]
      • Bunkyō City, Tôkyô [Tokyo], Japan, 113-8655
        • Not yet recruiting
        • The University of Tokyo Hospital
  • Mexico
    • Estado de Baja California
      • Col. Buenos Aires NorteTijuana, Estado de Baja California, Mexico, 22330
        • Not yet recruiting
        • Centro Oftalmologico de Tijuana, S.A de C.V.
    • Mexico City
      • Mexico City, Mexico City, Mexico, 4030
        • Not yet recruiting
        • Asociacion para Evitar la Ceguera en Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Not yet recruiting
        • Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
    • Puebla
      • Mexico, Puebla, Mexico, 6080
        • Not yet recruiting
        • Instituto de Oftalmologia ''Fundacion de Asistencia Privada Conde de Valenciana IAP - Ophthalmology
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Not yet recruiting
        • Universitair Medisch Centrum Utrecht - Ophthalmology
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1081 HZ
        • Not yet recruiting
        • Amsterdam UMC - Ophthalmology
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3011 BH
        • Not yet recruiting
        • The Rotterdam Eye Hospital - unspecified
  • Poland
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-704
        • Recruiting
        • OCHO Lublin Gabinety Okulistyczne
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 03-709
        • Recruiting
        • Samodzielny Publiczny Kliniczny Szpital Okulistyczny
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-594
        • Recruiting
        • Gabinet Okulistyczny Prof Edward Wylegala
  • South Korea
      • Seoul, South Korea, 5505
        • Not yet recruiting
        • Asan Medical Center - Asan Cancer Center
    • Gang'weondo [Kang-won-do]
      • Wŏnju, Gang'weondo [Kang-won-do], South Korea, 26426
        • Not yet recruiting
        • Yonsei University Wonju Severance Christian Hospital
    • Gwangju Gwang'Yeogsi [Kwangju-Kwangyokshi]
      • Gwangju, Gwangju Gwang'Yeogsi [Kwangju-Kwangyokshi], South Korea, 61469
        • Not yet recruiting
        • Chonnam National University Hospital - Ophthalmology
    • Gyeonggido [Kyonggi-do]
      • Bucheon-si, Gyeonggido [Kyonggi-do], South Korea, 14647
        • Not yet recruiting
        • The catholic university of Korea, Bucheon St.Mary's Hospital
    • Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
      • Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea, 2841
        • Not yet recruiting
        • Korea University Anam Hospital
      • Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea, 4401
        • Not yet recruiting
        • Soon Chun Hyang University Hospital Seoul
      • Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea, 6591
        • Not yet recruiting
        • The Catholic University of Korea, Seoul St. Mary's Hospital - Ophthalmology
  • Spain
      • Barcelona, Spain, 8035
        • Recruiting
        • I. Microcirugía Ocular - IMO - Oftalmología
      • Málaga, Spain, 29010
        • Not yet recruiting
        • Hospital Regional Universitario de Malaga
      • Valencia, Spain, 46015
        • Recruiting
        • Fundación de Oftalmología Médica de la Comunitat Valenciana
      • Valladolid, Spain, 47011
        • Recruiting
        • IOBA Instituto de Oftalmología Biologica Aplicada
    • A Coruna
      • A Coruña, A Coruna, Spain, 15006
        • Recruiting
        • Centro de Ojos de la Coruna
    • Andalusia
      • Cardona, Andalusia, Spain, 14012
        • Recruiting
        • Hospital La Arruzafa - Instituto de OftalmologÃ-a La Arruzafa
    • Barcelona
      • Badalona, Barcelona, Spain, 8916
        • Recruiting
        • Hospital Universitari Germans Trias i Pujol (HUGTP)
  • United Kingdom
      • Nottingham, United Kingdom, NG7 2UH
        • Not yet recruiting
        • Nottingham University Hospitals NHS Trust - Queen's Medical Centre
    • Bristol, City of
      • Bristol, Bristol, City of, United Kingdom, BS1 2LX
        • Recruiting
        • University Hospitals Bristol and Weston NHS Foundation Trust - Bristol Eye Hospital
    • England
      • Liverpool, England, United Kingdom, L78XP
        • Recruiting
        • Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital
    • York
      • London, York, United Kingdom, EC1V 2PD
        • Recruiting
        • Moorfields Eye Hospital
  • United States
    • California
      • Huntington Beach, California, United States, 92647
        • Recruiting
        • Azul Vision, INC
      • Laguna Hills, California, United States, 92653
        • Recruiting
        • Harvard Eye Associates
      • Loma Linda, California, United States, 92354
        • Not yet recruiting
        • Loma Linda University Adventist Health Sciences Center
      • Los Angeles, California, United States, 90095
        • Not yet recruiting
        • UCLA - Jules Stein Eye Institute (JSEI) - Diabetic Eye Dise
      • Redlands, California, United States, 92373
        • Recruiting
        • California Eye Specialists Medical Group, Inc.
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • East Coast Institute for Research - Florida Eye Specialists
      • Miami, Florida, United States, 33136
        • Recruiting
        • Bascom Palmer Eye Institute, University of Miami School of Medicine
      • Tampa, Florida, United States, 33620
        • Recruiting
        • University of South Florida
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts Eye and Ear
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Ophthalmic Consultants of Boston
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Not yet recruiting
        • University of Michigan Health - Kellogg Eye Center
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Recruiting
        • Midwest Vision Research Foundation
    • New York
      • New York, New York, United States, 10017
        • Not yet recruiting
        • NYU Langone Eye Center (Ophthalmology)
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Not yet recruiting
        • Duke Eye Center - Ophthalmology
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Recruiting
        • Vance Thompson Vision - Sioux Falls
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Eye Associates (HEA)
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Recruiting
        • The Eye Institute of Utah
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Eye Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cenegermin
Participants will be randomized to receive cenegermin ophthalmic solution in the study eye.
Drug: Cenegermin
Cenegermin is administered topically.
Placebo Comparator: Vehicle
Participants will be randomized to receive vehicle ophthalmic solution in the study eye.
Other: Vehicle
Vehicle is administered topically.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
At Weeks 4 and 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage change from baseline in maximum diameter of PCED at week 4
Time Frame: Baseline and Week 4
Baseline and Week 4
Percentage change from baseline in maximum diameter of PCED at week 8
Time Frame: Baseline and Week 8
Baseline and Week 8
Proportion of responders achieving complete epithelial healing of the cornea at Week 8 and maintained at Week 10
Time Frame: At Weeks 8 and 10
At Weeks 8 and 10
Linear change from baseline in maximum diameter of the PCED at week 4
Time Frame: Baseline and Week 4
Baseline and Week 4
Number of participants reporting Treatment Emergent Adverse Events (TEAEs)
Time Frame: Through Week 40
Through Week 40
Number of participants discontinuing the study due to intolerability
Time Frame: Through Week 40
Through Week 40

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dompé Farmaceutici S.p.A

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NGF-PCED-301
  • 2025-523443-35-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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