Cenegermin Eye Drops for Persistent Corneal Epithelial Defect in Patients with Persistent Corneal Epithelial Defect

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What is this study about?

This clinical trial is being done in people with Persistent Corneal Epithelial Defect (PCED), a condition in which the clear front surface of the eye does not heal properly. The study is testing cenegermin eye drops, given as an eye solution, and comparing them with a vehicle eye drop solution. Before the study eye drops are given, other eye drops such as oxybuprocaine hydrochloride, tetracaine hydrochloride, and tropicamide may be used as part of the eye care routine. The purpose of the study is to see whether cenegermin can help the eye surface heal better than the vehicle.

People in the study are assigned by chance to one of the eye drop groups. The study lasts for several weeks, and the eye is checked during treatment and again afterward to see whether healing has been maintained. The main focus is whether the damaged eye surface closes and stays healed over time.

Who Can Join the Study?

Be an adult, meaning 18 years of age or older.
Have persistent corneal epithelial defect (PCED) in the study eye, meaning a long-lasting open area on the clear front surface of the eye.
The PCED in the study eye must be at least 1.0 mm across at its widest point.
The PCED must have been present for at least 14 days.
The PCED must not have improved after one or more standard non-surgical treatments, such as:
- Ocular lubricants (eye drops or ointments that keep the eye moist)
- Stopping preserved drops and medications if they were irritating the eye
- Bandage contact lens use, which is a soft contact lens used to protect the eye while it heals
Be able to use most other eye medicines for eye problems other than PCED in the study eye, as long as the dose has been stable for at least 30 days and is not expected to change during the study.
Be allowed to keep taking prophylactic antibiotics in the study eye, if already using them before joining the study. Prophylactic antibiotics are medicines taken to help prevent infection.
Be able and willing to sign the informed consent form, which means agreeing to take part in the study and following all study rules and requirements.

Who Cannot Join the Study?

Cannot join if the other eye has no light perception (it cannot see any light) or if the other eye is completely missing.
Cannot join if there is active substance abuse or dependence, including alcohol, illegal drugs, marijuana, or misuse of prescription medicines within 30 days before randomization (the time when a person is assigned to a study treatment).
Cannot join if there is known or suspected eye cancer, including cancer on the eye surface, inside the eye, or around the eye, or if there is cancer or another serious body-wide disease that may interfere with study participation, in the investigator’s opinion, including basal cell carcinoma of the head.
Cannot join if any eye or body disease could make the study treatment less likely to work, make it hard to measure the results, or make the study schedule difficult to follow, in the investigator’s opinion.
Cannot join while taking part in another investigational study (a research study testing an unapproved treatment).
Cannot join if there is a known or suspected allergy to cenegermin or to any ingredient in the study medicine, or if there is a known allergy to study test medicines or procedures such as fluorescein (a dye used in eye exams).
Cannot join if there is an active eye infection in the study eye, including bacterial, fungal, or protozoal infection at screening.
Cannot join if there are active infectious stromal infiltrates or edema in the study eye; stromal infiltrates are infection-related deposits in the cornea, and edema means swelling.
Cannot join if there is acute anterior uveitis grade 2 or higher within 30 days before screening; uveitis is inflammation inside the eye.
Cannot join if there is recent intermediate uveitis or posterior uveitis within 30 days before screening.
Cannot join if there is active inflammation of the sclera or conjunctiva that is not part of the PCED; the sclera is the white part of the eye, and the conjunctiva is the thin clear covering over it.
Cannot join if the corneal epithelial defect has stromal thinning greater than 30%, meaning the deeper support layer of the cornea is too thin, or if it has a stromal infiltrate; corneal haze is allowed.
Cannot join if there is severe eyelid disease in the study eye, including eyelash or lid problems that touch the defect, lagophthalmos greater than 2 mm (the eyelids cannot fully close), known nighttime lagophthalmos, Parkinson’s disease, inability to fully close the eyelids on purpose, or severe ectropion (the eyelid turns outward) with poor eyelid-to-eye contact.
Cannot join if there is severe end-stage eye surface disease in the study eye, including very severe limbal stem cell deficiency affecting more than 270 degrees of the limbus (the border area of the cornea), or keratinization of the conjunctiva or eyelid edge, meaning tissue becomes thick and hardened like skin.
Cannot join if there was any prior use of cenegermin in the study eye.
Cannot join if certain local eye treatments were used in the study eye within 7 days before randomization, including autologous serum (eye drops made from the patient’s own blood), other surface-healing eye treatments, anesthetic drops used outside the exam setting, insulin eye use, or steroids unless they were part of treatment after surgery.
Cannot join if Botox injections were used for temporary eyelid closure within 90 days before randomization.
Cannot join if high-dose corticosteroids were taken by mouth or another systemic route within 30 days before randomization; corticosteroids are anti-inflammatory medicines.
Cannot join if oral medicines meant to treat the eye surface, such as doxycycline, were started, stopped, or changed within 30 days before randomization, or if such changes are planned during the study.
Cannot join if systemic opioids were used within 30 days before randomization; opioids are strong pain medicines.
Cannot join if any systemic investigational product, an investigational eye product in the study eye, radiation to the head or neck, or systemic chemotherapy was used within 90 days before randomization, or is planned during the study.
Cannot join if a contact lens, including a therapeutic contact lens, was used in the study eye within 7 days before randomization or is planned during the study.
Cannot join if there is an expected need for punctal occlusion in the study eye during the study; punctal occlusion means blocking the tear drainage opening. A person can still join if punctal plugs or punctal occlusion were already placed before the study and stay in place throughout the study.
Cannot join if there is an active severe body-wide illness, such as acute Stevens-Johnson syndrome, active graft-versus-host disease, severe Sjögren’s disease, or mucous membrane pemphigoid.
Cannot join if there is any body-wide disease that may affect the ability to take part in the study, according to the investigator’s judgment.
Cannot join if there was a recent major surgery for the eye defect within 14 days before randomization, such as a conjunctival flap, complete tarsorrhaphy (full eyelid closure by surgery), or superficial keratectomy for epithelial defect revision.
Cannot join if amniotic membrane therapy is still present in the area of the eye defect within 14 days before randomization, including sutured amniotic membrane, self-retaining amniotic membrane, contact lens with amniotic membrane, or other amniotic membrane treatment for the eye surface unless it has dissolved within the defect area.
Cannot join if partial tarsorrhaphy was placed within 14 days before randomization; partial tarsorrhaphy means partly sewing the eyelids together. If it was placed more than 14 days earlier, it must stay in place for the whole study.
Cannot join if a female who can become pregnant is known to be pregnant, has a positive pregnancy test, plans to become pregnant during the study, is breastfeeding, or is unwilling to use acceptable contraception until 30 days after study treatment ends.
Cannot join if a fertile male participant is unwilling to use acceptable contraception (a male condom with spermicidal cream or jelly) until 30 days after study treatment ends.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fundacion De Oftalmologia Medica De La Comunitat Valenciana	Valencia	Spain
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
ASST Fatebenefratelli Sacco	Milan	Italy
Hospital Santa Maria Della Misericordia	Perugia	Italy
Clinica De Oftalmologia De Cordoba S.L.	Cordoba	Spain
The Rotterdam Eye Hospital	Rotterdam	The Netherlands
Instituto Universitario De Oftalmobiologia Aplicada	Valladolid	Spain
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia	Rome	Italy
Fondation A De Rothschild	Paris	France
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Fakultni Nemocnice Brno	Brno	Czechia
Philipps-Universitaet Marburg	Marburg	Germany
Semmelweis University	Budapest	Hungary
Kliniken der Stadt Koeln gGmbH	Cologne	Germany
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Hopital Beaujon	Clichy	France
Centro De Ojos De La Coruna S.L.	A Coruna Galicia	Spain
Gabinety Okulistyczne Sp. z o.o.	Lublin	Poland
Universitätsklinikum des Saarlandes – Homburg/Saar, Klinik für Urologie und Kinderurologie	Homburg	Germany
Vbujdhk Ktdl	Eger	Hungary
Avjuyoong Ull	Amsterdam	The Netherlands
Cqxkcl Henjgzlfnes Riyklxth Uwifeghgoyevy Dc Tmtbz	Tours	France
Gfwyzn Uyuebzydja Fhrxnjtjn	Frankfurt	Germany
Ikvmbhypa Dn Mrdxwlvglufk Opkcyo Dfh Sjio	Barcelona	Spain
Ulccqbleqe Hglfssev Cuxbznb	Cologne	Germany
Gtkgzwp Ogbgiljhxjcm ppeqh Efwjcb Wydgcdqe	Katowice	Poland
Hsgedqmv Uaifssxyqxtmx Htfkhlcl Tkhwk y Pmgkic Iecshhbh Cmyvxi dlioqgkuuhrbvcdgk (hzhq	Badalona	Spain
Ijhsvzgo dv Ctwfswachpih Hdkqhmndpcn Uhhlczfgbldng dg Sezab Exfrymy (ehsgglf	Saint Priest En Jarez	France
Ubfsbyphcbsbqbhjbemdb Damvybpuaxm Axm	Duesseldorf	Germany
Snscenjlxgr Pfsbeorpd Kfvorfrbx Sxacycg Oslipzldtmok W Weqpiddba	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Czechia	Not yet recruiting	14.05.2026
France	Not yet recruiting	14.05.2026
Germany	Not yet recruiting	14.05.2026
Hungary	Not yet recruiting	14.05.2026
Italy	Not yet recruiting	14.05.2026
Poland	Recruiting	14.05.2026
Spain	Not yet recruiting	14.05.2026
The Netherlands	Not yet recruiting	14.05.2026

Trial locations

Investigated drugs:

Oxervate is an eye drop treatment that contains cenegermin, a man-made form of nerve growth factor. In this trial, it is the main study medicine being tested to help heal a persistent corneal epithelial defect, which is a wound on the surface of the eye that has not healed properly.

Colirofta anestésico doble is a numbing eye drop used before eye examinations or procedures. It contains two local anesthetics, oxybuprocaine hydrochloride and tetracaine hydrochloride, which help reduce pain and discomfort in the eye.

Tropicamide is an eye drop used to widen the pupil. This helps the study team examine the eye more clearly during the trial and monitor how the cornea is healing.

Investigated diseases:

Persistent corneal epithelial defect

Persistent Corneal Epithelial Defect – A persistent corneal epithelial defect is a condition in which the clear outer surface of the eye does not heal properly after an injury or irritation. The surface layer of the cornea remains open instead of closing as expected, often forming a lasting defect. It may stay the same for a time or slowly enlarge if healing does not occur.

Trial ID:

2025-523443-35-00

Protocol code:

NGF-PCED-301

Trial Phase:

Therapeutic confirmatory (Phase III)

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Cenegermin Eye Drops for Persistent Corneal Epithelial Defect in Patients with Persistent Corneal Epithelial Defect

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?