REC 0/0559 Eye Drops for Treatment of Moderate and Severe Neurotrophic Keratitis in Adult Patients

NCT04276558 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: REC0559-B-001
• Study Type: interventional
• Target: 108
• Locations: 7 countries
• Sites: 41

Brief 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.

Conditions

Neurotrophic Keratitis

Outcome Measures

Primary Outcomes (1)

• 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.

  At week 8

Secondary Outcomes (1)

• Visual Acuity

  At week 8

Study Arms (4)

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

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

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

Drug: Udonitrectag; Other: Vehicle

Vehicle

PLACEBO COMPARATOR

Dose of study drug per day: 0 µg/day Study drug concentration: Vehicle given 1 drop QID

Other: Vehicle

Interventions

Udonitrectag DRUG

Eye drop solution in single dose unit.

Also known as: REC 0/0559

Dose 1 - 0.5 µg/day; Dose 2 - 2.5 µg/day; Dose 3 - 5 µg/day

Vehicle OTHER

Eye drop solution with no active substance in single dose unit.

Dose 1 - 0.5 µg/day; Dose 2 - 2.5 µg/day; Dose 3 - 5 µg/day; Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• RECORDATI GROUP: lead
• Syneos Health: collaborator

Study Sites (41)

Nature Coast Clinical Research

Crystal River, Florida, 34429-8722, United States

Location

University of Florida

Gainesville, Florida, 32605, United States

Location

University of Maryland School of Medicine UMSOM

Baltimore, Maryland, 21201, United States

Location

University of Michigan - Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Location

Mt. Sinai New York Eye and Ear Infirmary

New York, New York, 10003, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Toyos Clinic

Nashville, Tennessee, 37215, United States

Location

Houston Eye Associates HEA - Gramercy Location

Houston, Texas, 77025, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

Location

Dijon University Hospital CHU Dijon

Dijon, 21000, France

Location

CHU Paris Centre - Hôpital Cochin

Paris, 75014, France

Location

Hôpital Fondation Adolphe de Rothschild

Paris, France

Location

Hôpital Universitaire Necker

Paris, France

Location

Ludwig-Maximilians-Universitaet Muenchen LMU - Augenklinik

Munich, Bavaria, 80336, Germany

Location

Uniklinik Koeln

Cologne, 50924, Germany

Location

Hospital Eye University of Duesseldorf

Düsseldorf, 40225, Germany

Location

Universitaetsklinikum Frankfurt

Frankfurt, 60590, Germany

Location

Saarland University Medical Center

Homburg, Germany

Location

UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Markusovszky University Teaching Hospital

Szombathely, Vas County, 9700, Hungary

Location

Semmelweis University, Dept. of Ophthalmology

Budapest, Hungary

Location

University of Pecs - Dpt of Ophthalmology

Pécs, Hungary

Location

Università Magna Grecia di Catanzaro

Germaneto, Calabria, 88100, Italy

Location

Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari Clinica Oculistica

Bari, 70124, Italy

Location

DIMES Universit di Bologna

Bologna, 40138, Italy

Location

Azienda Ospedaliero-Universitaria Careggi

Florence, 50134, Italy

Location

Ospedali Privato

Forlì, Italy

Location

Azienda Ospedaliera Universitaria San Martino

Genova, 16132, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Gaetano Martino

Messina, Italy

Location

Ospedale Luigi Sacco

Milan, 20157, Italy

Location

Fondazione PTV - Policlinico Tor Vergata

Roma, 00133, Italy

Location

Instituto Oftalmologico Fernandez-Vega

Oviedo, Principality of Asturias, 33012, Spain

Location

Hospital de Cruces

Barakaldo, 48903, Spain

Location

Instituto Microcirugia Ocular IMO

Barcelona, 08035, Spain

Location

Centro de Oftalmologia Barraquer

Barcelona, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Cartuja Vision - Centro de Servicios Oftlamologicos

Seville, Spain

Location

Royal Liverpool University Hospital - St Paul's Clinical Eye Research Centre

Liverpool, Mersey, L7 8XP, United Kingdom

Location

University Hospital Hairmyres

Glasgow, G75 8RG, United Kingdom

Location

Moorfields Eye Hospital NHS Foundation Trust

London, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Results Point of Contact

• Title: Beatrice Martin, Clinical study Manager
• Organization: Recordati Rare Diseases Sarl

martin.be@recordati.com

+33 1 47 73 64 58

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-masked: dose and nature of the product
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 19, 2020
• Study Start: October 13, 2020
• Primary Completion: April 29, 2024
• Study Completion: April 29, 2024
• Last Updated: May 14, 2025
• Results First Posted: May 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (3); FR (4); IT (9); ES (6); DE (6); GB (4); US (9)