Neurotrophic KeratitisPhase 2NCT04276558
REC 0/0559 Eye Drops for Treatment of Moderate and Severe Neurotrophic Keratitis in Adult Patients
A Phase 2 study testing Udonitrectag in people with Neurotrophic Keratitis, run by RECORDATI GROUP at 41 sites in 7 countries.
Trial summary
A phase 2 study, aiming to evaluate the efficacy, safety and pharmacokinetics of REC 0/0559 in treatment of Neurotrophic Keratitis in Adult Patient in Europe and United States of America. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurotrophic Keratitis
- What is being tested?
- Udonitrectag
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 41 sitesin 7 countries
- Study dates
- 13 Oct 2020to 29 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Have read, understood, and signed the informed consent form (ICF).
- Be a male or female aged ≥18 years at the time of ICF signature.
- Have stage 2 moderate (PED) or stage 3 severe (corneal ulcer) NK involving only 1 eye (study eye) and of at least 2 weeks duration. Patients with Stage 1 NK in the fellow eye can be enrolled.
- for the study eye
- Have no objective clinical evidence of improvement in the PED or corneal ulceration within the 2 weeks before the screening visit despite use of conventional non-surgical treatment (eg, nonpreserved ocular lubricants, nonpreserved topical antibiotics, oral doxycycline, patching, serum tears, and/or therapeutic contact lenses) as determined by the investigator's or referring physician's medical record.
- Have decreased corneal sensitivity (≤ 4 cm using the Cochet-Bonnet aesthesiometer) within the area of the PED or corneal ulcer and outside of the area of the defect in at least one corneal quadrant.
- Have a BCDVA score ≤ 75 ETDRS letters in the study eye, due to NK.
Who cannot join
- Have participated in any clinical trial with an investigational drug/device within 2 months before the Screening Visit and throughout the study duration.
- Have a known hypersensitivity to one of the components of the study drug or procedural medications (eg, fluorescein), including to a compound chemically related to MT8
- Have a presence or history of any ocular or systemic disorder or condition that might hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct (eg, progressive or degenerative corneal or retinal conditions, lagophthalmos, uveitis, optic neuritis, poorly controlled diabetes, autoimmune disease, systemic infection, neoplastic diseases), or that may compromise the safety of the patient.
- Have a significant history of alcohol abuse or drug/solvent abuse
- Be unwilling to comply with any study assessments or procedures.
- Be a woman who is pregnant, nursing or planning a pregnancy.
Show all 26Show fewer
- Be a woman of childbearing potential not using a highly effective method of birth control.
- Be a male patient who is not permanently sterile and who is not willing to use condoms during the study and for 4 weeks after the end of study treatment.
- For the study eye:
- Have any active ocular infection (bacterial, viral, fungal or protozoal) or active inflammation not related to NK in the study eye.
- Have any other ocular disease requiring topical ocular treatment in the study eye during the course of the study treatment period, except for glaucoma if treated by preservative-free eye drop (single-agent treatment, once daily, stable regimen 4 weeks before screening and during the study),
- Receive topical ophthalmological treatments other than the study drug provided by the study Sponsor and the treatments allowed by the study protocol (eg, preservative-free artificial tears; preservative-free eye drop (single-agent treatment, once daily, stable regimen 4 weeks before screening and during the study) for glaucoma; topical antibiotics; other than tetracycline).
- Have severe blepharitis and/or severe meibomian gland disease in the study eye.
- Have severe vision loss in the study eye with no potential for visual improvement in the opinion of the investigator as a result of the study treatment.
- Have evidence of corneal ulceration/melting involving the posterior third of the corneal stroma, or perforation in the study eye.
- Have a history of any ocular surgery (including laser or refractive surgical procedures) within 3 months before the Screening Visit in the study eye. An exception to the preceding statement will be allowed if the ocular surgery is considered to be the cause of the Stage 2 or 3 NK.
- Have a history of corneal transplantation in the study eye, except if performed to treat NK and at least 6 months prior screening.
- Have had prior surgical procedures for the treatment of NK (eg, tarsorrhaphy, conjunctival flap, etc.) except AMT, if at least 2 wks after the membrane has disappeared within the area of the PED or corneal ulcer (and at least 6 weeks after the procedure) in the study eye.
- Use therapeutic contact lenses or wear contact lenses for refractive correction during the study treatment periods in the eye(s) with NK.
- Have an anticipated need for punctal occlusion during the study treatment period. Patients with punctal occlusion or punctal plugs inserted before the study are eligible for enrolment provided that the punctal occlusion is maintained during the study.
- Have an uncontrolled glaucoma at the Screening Visit. (Patients suffering from glaucoma requiring ophthalmic drops for topical treatment at the Screening Visit or during the study are not eligible, except if the ophthalmic drops is a preservative-free treatment administered maximum once daily as a single-agent treatment and at a stable regimen 4 weeks before screening and at the same dose during the study. Patients treated with oral intraocular pressure-lowering drugs at the Screening Visit and during the study may be enrolled if their glaucoma status is assessed as stable and controlled.
- For the fellow eye
- Have Stage 2 or 3 NK or perforation.
- For any eye:
- Have a history of ocular cancer.
- Have had prior treatment with Oxervate™
Trial locations and contacts
41 sites in 7 countries.
41 sites in 7 countries
United States9 sites
University of Michigan - Kellogg Eye Center
Ann Arbor, Michigan, 48105
University of Maryland School of Medicine UMSOM
Baltimore, Maryland, 21201
Nature Coast Clinical Research
Crystal River, Florida, 34429-8722
University of Florida
Gainesville, Florida, 32605
Houston Eye Associates HEA - Gramercy Location
Houston, Texas, 77025
University of Wisconsin-Madison
Madison, Wisconsin, 53705
Toyos Clinic
Nashville, Tennessee, 37215
Mt. Sinai New York Eye and Ear Infirmary
New York, New York, 10003
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Italy9 sites
Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari Clinica Oculistica
Bari, 70124
DIMES Universit di Bologna
Bologna, 40138
Azienda Ospedaliero-Universitaria Careggi
Florence, 50134
Ospedali Privato
Forlì
Azienda Ospedaliera Universitaria San Martino
Genova, 16132
Università Magna Grecia di Catanzaro
Germaneto, Calabria, 88100
Azienda Ospedaliera Universitaria Policlinico Gaetano Martino
Messina
Ospedale Luigi Sacco
Milan, 20157
Fondazione PTV - Policlinico Tor Vergata
Roma, 00133
Germany6 sites
Uniklinik Koeln
Cologne, 50924
Hospital Eye University of Duesseldorf
Düsseldorf, 40225
Universitaetsklinikum Frankfurt
Frankfurt, 60590
Saarland University Medical Center
Homburg
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Ludwig-Maximilians-Universitaet Muenchen LMU - Augenklinik
Munich, Bavaria, 80336
Spain6 sites
Hospital de Cruces
Barakaldo, 48903
Instituto Microcirugia Ocular IMO
Barcelona, 08035
Centro de Oftalmologia Barraquer
Barcelona
Hospital Clinico San Carlos
Madrid, 28040
Instituto Oftalmologico Fernandez-Vega
Oviedo, Principality of Asturias, 33012
Cartuja Vision - Centro de Servicios Oftlamologicos
Seville
France4 sites
Dijon University Hospital CHU Dijon
Dijon, 21000
CHU Paris Centre - Hôpital Cochin
Paris, 75014
Hôpital Fondation Adolphe de Rothschild
Paris
Hôpital Universitaire Necker
Paris
United Kingdom4 sites
University Hospital Hairmyres
Glasgow, G75 8RG
Royal Liverpool University Hospital - St Paul's Clinical Eye Research Centre
Liverpool, Mersey, L7 8XP
Moorfields Eye Hospital NHS Foundation Trust
London
Southampton General Hospital
Southampton, SO16 6YD
Hungary3 sites
Semmelweis University, Dept. of Ophthalmology
Budapest
University of Pecs - Dpt of Ophthalmology
Pécs
Markusovszky University Teaching Hospital
Szombathely, Vas County, 9700
About this study
Official title: Efficacy, Safety and Pharmacokinetics of 3 Doses of REC 0/0559 Eye Drops for the Treatment of Stage 2 (Moderate) and 3 (Severe) Neurotrophic Keratitis in Adult Patients
A phase 2 study, aiming to evaluate the efficacy, safety and pharmacokinetics of REC 0/0559 in treatment of Neurotrophic Keratitis in Adult Patient in Europe and United States of America.
Read the detailed description
This was a Phase 2, international, multicentre, dose-ranging, double-masked, randomised, parallel-group, vehicle-controlled study designed to evaluate 3 different doses of REC 0/0559 vs vehicle in patients with Stage 2 and Stage 3 neurotrophic keratitis (NK).
- Conditions
- Neurotrophic Keratitis
- Being tested
- Udonitrectag, Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UdonitrectagDrug
Also called REC 0/0559
Eye drop solution in single dose unit.
VehicleOther
Eye drop solution with no active substance in single dose unit.
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 - 0.5 µg/day | Experimental | Dose of study drug per day: 0.5 µg/day Study drug concentration: 5 µg/mL MT8 given 1 drop QID Receives: Drug: Udonitrectag; Other: Vehicle |
| Dose 2 - 2.5 µg/day | Experimental | Dose of study drug per day: 2.5 µg/day Study drug concentration: 25 µg/mL MT8 given 1 drop QID Receives: Drug: Udonitrectag; Other: Vehicle |
| Dose 3 - 5 µg/day | Experimental | Dose of study drug per day: 5 µg/day Study drug concentration: 50 µg/mL MT8 given 1 drop QID Receives: Drug: Udonitrectag; Other: Vehicle |
| Vehicle | Placebo comparator | Dose of study drug per day: 0 µg/day Study drug concentration: Vehicle given 1 drop QID Receives: Other: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Healing
The primary endpoint of this study is the percentage of patients achieving complete corneal healing of PED or corneal ulcer at Week 8, defined as no corneal fluorescein staining in the area of the PED or corneal ulcer as assessed by an independent central reading centre.
Measured: At week 8
Secondary outcomes (1)
Visual Acuity
Percentage of patients who achieve a 5-, 10-, and 15-letter mean improvement in best corrected distance visual acuity (BCDVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Week 8 compared to baseline (in all patients and in patients with a central location of the PED or corneal ulcer, respectively).
Measured: At week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start13 Oct 2020
- Primary completion29 Apr 2024
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neurotrophic KeratitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study will have an initial period of dose escalation followed by a parallel recruitment period. Randomisation in the first 24 patients will be sequential and after, patients will be randomised to all 4 treatment arms.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- RECORDATI GROUP
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276558
- Sponsor's protocol ID
- REC0559-B-001
- Status last verified
- Sep 2026
- First submitted
- 17 Feb 2020
- Last updated
- 6 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Pharmacokinetics of 3 Doses of REC 0/0559 Eye Drops for the Treatment of Stage 2 (Moderate) and 3 (Severe) Neurotrophic Keratitis in Adult Patients
- ClinicalTrials.gov ID
- NCT04276558
- Acronym / sponsor ID
- REC0559-B-001
- Conditions
- Neurotrophic Keratitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- RECORDATI GROUPIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 19 Feb 2020 (actual)
- Results
- Posted 14 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 2 study, aiming to evaluate the efficacy, safety and pharmacokinetics of REC 0/0559 in treatment of Neurotrophic Keratitis in Adult Patient in Europe and United States of America.
Detailed description
This was a Phase 2, international, multicentre, dose-ranging, double-masked, randomised, parallel-group, vehicle-controlled study designed to evaluate 3 different doses of REC 0/0559 vs vehicle in patients with Stage 2 and Stage 3 neurotrophic keratitis (NK).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- The study will have an initial period of dose escalation followed by a parallel recruitment period. Randomisation in the first 24 patients will be sequential and after, patients will be randomised to all 4 treatment arms.
| Arm | Type | Receives |
|---|---|---|
| Dose 1 - 0.5 µg/day | Experimental | Drug: Udonitrectag, Other: VehicleDose of study drug per day: 0.5 µg/day Study drug concentration: 5 µg/mL MT8 given 1 drop QID |
| Dose 2 - 2.5 µg/day | Experimental | Drug: Udonitrectag, Other: VehicleDose of study drug per day: 2.5 µg/day Study drug concentration: 25 µg/mL MT8 given 1 drop QID |
| Dose 3 - 5 µg/day | Experimental | Drug: Udonitrectag, Other: VehicleDose of study drug per day: 5 µg/day Study drug concentration: 50 µg/mL MT8 given 1 drop QID |
| Vehicle | Placebo comparator | Other: VehicleDose of study drug per day: 0 µg/day Study drug concentration: Vehicle given 1 drop QID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have read, understood, and signed the informed consent form (ICF).
- Be a male or female aged ≥18 years at the time of ICF signature.
- Have stage 2 moderate (PED) or stage 3 severe (corneal ulcer) NK involving only 1 eye (study eye) and of at least 2 weeks duration. Patients with Stage 1 NK in the fellow eye can be enrolled.
- for the study eye
- Have no objective clinical evidence of improvement in the PED or corneal ulceration within the 2 weeks before the screening visit despite use of conventional non-surgical treatment (eg, nonpreserved ocular lubricants, nonpreserved topical antibiotics, oral doxycycline, patching, serum tears, and/or therapeutic contact lenses) as determined by the investigator's or referring physician's medical record.
Key exclusion criteria (26 listed)
- Have participated in any clinical trial with an investigational drug/device within 2 months before the Screening Visit and throughout the study duration.
- Have a known hypersensitivity to one of the components of the study drug or procedural medications (eg, fluorescein), including to a compound chemically related to MT8
- Have a presence or history of any ocular or systemic disorder or condition that might hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct (eg, progressive or degenerative corneal or retinal conditions, lagophthalmos, uveitis, optic neuritis, poorly controlled diabetes, autoimmune disease, systemic infection, neoplastic diseases), or that may compromise the safety of the patient.
- Have a significant history of alcohol abuse or drug/solvent abuse
- Be unwilling to comply with any study assessments or procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UdonitrectagAlso: REC 0/0559Eye drop solution in single dose unit. | Drug | Dose 1 - 0.5 µg/day, Dose 2 - 2.5 µg/day, Dose 3 - 5 µg/day |
| VehicleEye drop solution with no active substance in single dose unit. | Other | Dose 1 - 0.5 µg/day, Dose 2 - 2.5 µg/day, Dose 3 - 5 µg/day, Vehicle |
Primary outcome
Corneal Healing
Time frame: At week 8
The primary endpoint of this study is the percentage of patients achieving complete corneal healing of PED or corneal ulcer at Week 8, defined as no corneal fluorescein staining in the area of the PED or corneal ulcer as assessed by an independent central reading centre.
1 secondary outcome
Visual Acuity
Time frame: At week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
41 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Udonitrectag in people with Neurotrophic Keratitis, run by RECORDATI GROUP at 41 sites in 7 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 7 inclusion and 26 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: finished, as of the sponsor's last update on 6 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 41 sites in United States, Italy, Germany, Spain, France and 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal Healing (time frame: At week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.