REC 0/0559 Øyedråper for behandling av moderat og alvorlig nevrotrofisk keratitt hos voksne pasienter
Effekt, sikkerhet og farmakokinetikk av 3 doser REC 0/0559 øyedråper for behandling av stadium 2 (moderat) og 3 (alvorlig) nevrotrofisk keratitt hos voksne pasienter
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Florida
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Crystal River, Florida, Forente stater, 34429-8722
- Nature Coast Clinical Research
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Gainesville, Florida, Forente stater, 32605
- University of Florida
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Maryland
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Baltimore, Maryland, Forente stater, 21201
- University of Maryland School of Medicine UMSOM
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Michigan
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Ann Arbor, Michigan, Forente stater, 48105
- University of Michigan - Kellogg Eye Center
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New York
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New York, New York, Forente stater, 10003
- Mt. Sinai New York Eye and Ear Infirmary
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North Carolina
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Winston-Salem, North Carolina, Forente stater, 27157
- Wake Forest Baptist Medical Center
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Tennessee
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Nashville, Tennessee, Forente stater, 37215
- Toyos Clinic
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Texas
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Houston, Texas, Forente stater, 77025
- Houston Eye Associates HEA - Gramercy Location
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Wisconsin
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Madison, Wisconsin, Forente stater, 53705
- University of Wisconsin-Madison
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Dijon, Frankrike, 21000
- Dijon University Hospital CHU Dijon
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Paris, Frankrike
- Hôpital Fondation Adolphe de Rothschild
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Paris, Frankrike, 75014
- CHU Paris Centre - Hôpital Cochin
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Paris, Frankrike
- Hôpital Universitaire Necker
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Bari, Italia, 70124
- Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari Clinica Oculistica
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Bologna, Italia, 40138
- DIMES Universit di Bologna
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Florence, Italia, 50134
- Azienda Ospedaliero-Universitaria Careggi
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Forlì, Italia
- Ospedali Privato
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Genova, Italia, 16132
- Azienda Ospedaliera Universitaria San Martino
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Messina, Italia
- Azienda Ospedaliera Universitaria Policlinico Gaetano Martino
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Milan, Italia, 20157
- Ospedale Luigi Sacco
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Roma, Italia, 00133
- Fondazione PTV - Policlinico Tor Vergata
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Calabria
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Germaneto, Calabria, Italia, 88100
- Università Magna Grecia di Catanzaro
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Barakaldo, Spania, 48903
- Hospital de Cruces
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Barcelona, Spania
- Centro de Oftalmologia Barraquer
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Barcelona, Spania, 08035
- Instituto Microcirugia Ocular IMO
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Madrid, Spania, 28040
- Hospital Clinico San Carlos
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Seville, Spania
- Cartuja Vision - Centro de Servicios Oftlamologicos
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Principality of Asturias
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Oviedo, Principality of Asturias, Spania, 33012
- Instituto Oftalmologico Fernandez-Vega
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Glasgow, Storbritannia, G75 8RG
- University Hospital Hairmyres
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London, Storbritannia
- Moorfields Eye Hospital NHS Foundation Trust
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Southampton, Storbritannia, SO16 6YD
- Southampton General Hospital
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Mersey
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Liverpool, Mersey, Storbritannia, L7 8XP
- Royal Liverpool University Hospital - St Paul's Clinical Eye Research Centre
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Cologne, Tyskland, 50924
- Uniklinik Koeln
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Düsseldorf, Tyskland, 40225
- Hospital Eye University of Duesseldorf
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Frankfurt, Tyskland, 60590
- Universitaetsklinikum Frankfurt
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Homburg, Tyskland
- Saarland University Medical Center
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Mainz, Tyskland, 55131
- UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
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Bavaria
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Munich, Bavaria, Tyskland, 80336
- Ludwig-Maximilians-Universitaet Muenchen LMU - Augenklinik
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Budapest, Ungarn
- Semmelweis University, Dept. of Ophthalmology
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Pécs, Ungarn
- University of Pecs - Dpt of Ophthalmology
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Vas County
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Szombathely, Vas County, Ungarn, 9700
- Markusovszky University Teaching Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
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Have read, understood, and signed the informed consent form (ICF).
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Be a male or female aged ≥18 years at the time of ICF signature.
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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
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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.
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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.
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Have a BCDVA score ≤ 75 ETDRS letters in the study eye, due to NK.
Exclusion Criteria:
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Have participated in any clinical trial with an investigational drug/device within 2 months before the Screening Visit and throughout the study duration.
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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
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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.
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Have a significant history of alcohol abuse or drug/solvent abuse
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Be unwilling to comply with any study assessments or procedures.
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Be a woman who is pregnant, nursing or planning a pregnancy.
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Be a woman of childbearing potential not using a highly effective method of birth control.
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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:
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Have any active ocular infection (bacterial, viral, fungal or protozoal) or active inflammation not related to NK in the study eye.
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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),
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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).
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Have severe blepharitis and/or severe meibomian gland disease in the study eye.
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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.
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Have evidence of corneal ulceration/melting involving the posterior third of the corneal stroma, or perforation in the study eye.
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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.
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Have a history of corneal transplantation in the study eye, except if performed to treat NK and at least 6 months prior screening.
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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.
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Use therapeutic contact lenses or wear contact lenses for refractive correction during the study treatment periods in the eye(s) with NK.
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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.
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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
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Have Stage 2 or 3 NK or perforation.
For any eye:
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Have a history of ocular cancer.
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Have had prior treatment with Oxervate™
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Dose 1 - 0.5 µg/day
Dose of study drug per day: 0.5 µg/day Study drug concentration: 5 µg/mL MT8 given 1 drop QID |
Eye drop solution in single dose unit.
Andre navn:
Eye drop solution with no active substance in single dose unit. |
|
Eksperimentell: Dose 2 - 2.5 µg/day
Dose of study drug per day: 2.5 µg/day Study drug concentration: 25 µg/mL MT8 given 1 drop QID |
Eye drop solution in single dose unit.
Andre navn:
Eye drop solution with no active substance in single dose unit. |
|
Eksperimentell: Dose 3 - 5 µg/day
Dose of study drug per day: 5 µg/day Study drug concentration: 50 µg/mL MT8 given 1 drop QID |
Eye drop solution in single dose unit.
Andre navn:
Eye drop solution with no active substance in single dose unit. |
|
Placebo komparator: Vehicle
Dose of study drug per day: 0 µg/day Study drug concentration: Vehicle given 1 drop QID |
Eye drop solution with no active substance in single dose unit. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Corneal Healing
Tidsramme: 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. |
At week 8
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Visual Acuity
Tidsramme: At week 8
|
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). |
At week 8
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- REC0559-B-001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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