REC 0/0559 oogdruppels voor de behandeling van matige en ernstige neurotrofe keratitis bij volwassen patiënten
Werkzaamheid, veiligheid en farmacokinetiek van 3 doses REC 0/0559 oogdruppels voor de behandeling van stadium 2 (matig) en 3 (ernstig) neurotrofe keratitis bij volwassen patiënten
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Cologne, Duitsland, 50924
- Uniklinik Koeln
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Düsseldorf, Duitsland, 40225
- Hospital Eye University of Duesseldorf
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Frankfurt, Duitsland, 60590
- Universitaetsklinikum Frankfurt
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Homburg, Duitsland
- Saarland University Medical Center
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Mainz, Duitsland, 55131
- UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
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Bavaria
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Munich, Bavaria, Duitsland, 80336
- Ludwig-Maximilians-Universitaet Muenchen LMU - Augenklinik
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Dijon, Frankrijk, 21000
- Dijon University Hospital CHU Dijon
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Paris, Frankrijk
- Hôpital Fondation Adolphe de Rothschild
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Paris, Frankrijk, 75014
- CHU Paris Centre - Hôpital Cochin
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Paris, Frankrijk
- Hôpital Universitaire Necker
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Budapest, Hongarije
- Semmelweis University, Dept. of Ophthalmology
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Pécs, Hongarije
- University of Pecs - Dpt of Ophthalmology
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Vas County
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Szombathely, Vas County, Hongarije, 9700
- Markusovszky University Teaching Hospital
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Bari, Italië, 70124
- Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari Clinica Oculistica
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Bologna, Italië, 40138
- DIMES Universit di Bologna
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Florence, Italië, 50134
- Azienda Ospedaliero-Universitaria Careggi
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Forlì, Italië
- Ospedali Privato
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Genova, Italië, 16132
- Azienda Ospedaliera Universitaria San Martino
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Messina, Italië
- Azienda Ospedaliera Universitaria Policlinico Gaetano Martino
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Milan, Italië, 20157
- Ospedale Luigi Sacco
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Roma, Italië, 00133
- Fondazione PTV - Policlinico Tor Vergata
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Calabria
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Germaneto, Calabria, Italië, 88100
- Università Magna Grecia di Catanzaro
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Barakaldo, Spanje, 48903
- Hospital de Cruces
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Barcelona, Spanje
- Centro de Oftalmologia Barraquer
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Barcelona, Spanje, 08035
- Instituto Microcirugia Ocular IMO
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Madrid, Spanje, 28040
- Hospital Clinico San Carlos
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Seville, Spanje
- Cartuja Vision - Centro de Servicios Oftlamologicos
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Principality of Asturias
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Oviedo, Principality of Asturias, Spanje, 33012
- Instituto Oftalmologico Fernandez-Vega
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Glasgow, Verenigd Koninkrijk, G75 8RG
- University Hospital Hairmyres
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London, Verenigd Koninkrijk
- Moorfields Eye Hospital NHS Foundation Trust
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Southampton, Verenigd Koninkrijk, SO16 6YD
- Southampton General Hospital
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Mersey
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Liverpool, Mersey, Verenigd Koninkrijk, L7 8XP
- Royal Liverpool University Hospital - St Paul's Clinical Eye Research Centre
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Florida
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Crystal River, Florida, Verenigde Staten, 34429-8722
- Nature Coast Clinical Research
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Gainesville, Florida, Verenigde Staten, 32605
- University of Florida
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21201
- University of Maryland School of Medicine UMSOM
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48105
- University of Michigan - Kellogg Eye Center
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New York
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New York, New York, Verenigde Staten, 10003
- Mt. Sinai New York Eye and Ear Infirmary
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North Carolina
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Winston-Salem, North Carolina, Verenigde Staten, 27157
- Wake Forest Baptist Medical Center
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Tennessee
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Nashville, Tennessee, Verenigde Staten, 37215
- Toyos Clinic
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Texas
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Houston, Texas, Verenigde Staten, 77025
- Houston Eye Associates HEA - Gramercy Location
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Wisconsin
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Madison, Wisconsin, Verenigde Staten, 53705
- University of Wisconsin-Madison
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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™
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
Andere namen:
Eye drop solution with no active substance in single dose unit. |
|
Experimenteel: 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.
Andere namen:
Eye drop solution with no active substance in single dose unit. |
|
Experimenteel: 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.
Andere namen:
Eye drop solution with no active substance in single dose unit. |
|
Placebo-vergelijker: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Corneal Healing
Tijdsspanne: At week 8
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Visual Acuity
Tijdsspanne: At week 8
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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
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- REC0559-B-001
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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