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    Summary
    EudraCT Number:2021-006765-38
    Sponsor's Protocol Code Number:OXUCT-101
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-02-10
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-006765-38
    A.3Full title of the trial
    A Multi-Center, Open-label, 24-week Clinical Investigation to Evaluate Safety and Tolerability of Treatment with the Oxulumis®, Suprachoroidal Drug Administration Device, Delivering 2.4mg Triamcinolone Acetonide (Triesence®) in Participants with Diabetic Macular Edema.
    Studio Clinico Multicentrico, in aperto, di 24 Settimane per Valutare la Sicurezza e la Tollerabilità del Trattamento con Oxulumis®, Dispositivo per la Somministrazione di Farmaci a Livello Sopra-coroideale, nella Somministrazione di 2.4 mg di Triamcinolone Acetonide (Triesence®) in Pazienti con Edema Maculare Diabetico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Investigation to Evaluate Safety and Tolerability of Treatment with the Oxulumis®, Suprachoroidal Drug Administration Device, Delivering 2.4mg Triamcinolone Acetonide (Triesence®) in Participants with Diabetic Macular Edema.
    Studio Clinico per Valutare la Sicurezza e la Tollerabilità del Trattamento con Oxulumis®, Dispositivo per la Somministrazione di Farmaci a Livello Sopra-coroideale, nella Somministrazione di 2.4 mg di Triamcinolone Acetonide (Triesence®) in Pazienti con Edema Maculare Diabetico.
    A.3.2Name or abbreviated title of the trial where available
    OXUCT-101
    OXUCT-101
    A.4.1Sponsor's protocol code numberOXUCT-101
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05172401
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOxular Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOXULAR Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDati & Ricerca
    B.5.2Functional name of contact pointCoordinamento Scientifico
    B.5.3 Address:
    B.5.3.1Street AddressVia San Valentino 7
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00197
    B.5.3.4CountryItaly
    B.5.4Telephone number+39335377929
    B.5.6E-mailsfm.marini@gmail.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name TRIESENCE
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Farma S.p.A
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTRIESENCE
    D.3.2Product code [042015042]
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRIAMCINOLONE ACETONIDE
    D.3.9.1CAS number 3869-32-7
    D.3.9.2Current sponsor codeOXUCT-101
    D.3.9.3Other descriptive nameTriamcinolone acetamide
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetic Macular Edema
    Edema Maculare Diabetico
    E.1.1.1Medical condition in easily understood language
    Diabetic Macular Edema
    Edema Maculare Diabetico
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10057915
    E.1.2Term Diabetic macular oedema
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of using the Oxulumis® device to administer Triesence® to the suprachoroidal space in subjects with DME.
    Valutare la sicurezza e la tollerabilità dell’utilizzo del dispositivo Oxulumis® per la somministrazione di Triesence® nello spazio sopra coroideale in soggetti con DME.
    E.2.2Secondary objectives of the trial
    To explore the efficacy in respect to visual acuity changes, edema control, and durability of the treatment effect of suprachoroidal Triesence® in subjects with DME.
    Esplorare l’efficacia in relazione ai cambiamenti dell’acuità visiva, controllo dell’edema, e durata dell’effetto del trattamento sopra coroideale con Triesence® in soggetti con DME.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to understand and sign an informed consent form.
    2. At least 18 years of age at the time of screening.
    3. Have been diagnosed with Type 1 or Type 2 diabetes mellitus.
    4. Have DME involving the center of the fovea in the study eye with a CRT, at the screening visit, of:
    • = 320 for males or = 305 for females on Spectralis (Heidelberg)
    or
    • = 305 for males or = 290 for females with Cirrus (Zeiss) by SD-OCT.
    5. Have BCVA in the study eye between 34 and 68 letters ETDRS (approximate Snellen acuity of 20/200–20/50*) at the screening visit.
    6. Have shown limited response to previous IVT treatment with anti-VEGF agents or local corticosteroid treatment (IVT, subtenon, topical) defined as less than 20% reduction of CST with previous treatments.
    7. Study eye suitable for suprachoroidal injection in the judgment of the investigator in agreement with the medical monitor. Patients with ocular hypotony, or structural abnormalities like choroidal coloboma, or chorioretinal anastimosis, amongst others, are not eligible.
    * For eligibility assessments, only the ETDRS BCVA measurement is considered relevant.
    1. Capacità di comprendere e firmare il modulo di consenso informato.
    2. Età almeno superior a 18 anni al momento della selezione.
    3. Avere ricevuto una diagnosi di diabete mellito di Tipo 1 o Tipo 2.
    4. Aver ricevuto una diagnosi di DME che coinvolga il centro della fovea nell’occhio dello studio, con una CRT, alla visita di selezione, di:
    • = 320 per i soggetti maschili o = 305 per i soggetti femminili allo Spectralis (Heidelberg)
    o
    • = 305 per i soggetti maschili o = 290 per i soggetti femminili con Cirrus (Zeiss) attraverso SD-OCT.
    5. Avere una BCVA all’occhio in studio tra 34 e 68 lettere ETDRS (acutezza Snellen approssimativa di 20/200–20/50*) alla visita di selezione.
    6. Avere mostrato una risposta limitata ad un trattamento IVT con agenti anti-VEGF o un trattamento locale con corticosteroidi (IVT, sotto capsula Tenone, topico) definito come riduzione del CST inferiore al 20% con trattamenti precedenti.
    7. Occhio in studio idoneo all'iniezione sopra coroideale a giudizio dello sperimentatore in accordo con il monitor medico. I pazienti con ipotonia oculare o anomalie strutturali come coloboma coroideo o anastomosi corioretinica, tra le altre, non sono idonei.
    * Per le valutazioni di ammissibilità, è considerata rilevante solo la misurazione ETDRS BCVA.
    E.4Principal exclusion criteria
    1. Presence of any other ocular condition in the study eye such that, in the opinion of the investigator, visual acuity may not improve from the resolution of macular
    edema (e.g., foveal atrophy, pigment abnormalities, or nonretinal causes).
    2. Active proliferative diabetic retinopathy (PDR) or sequelae of PDR (including iris neovascularization, vitreous hemorrhage, or tractional retinal detachment) at screening in the study eye.
    3. Pan-retinal photocoagulation (PRP) or macular laser photocoagulation in the study eye performed within sixteen (16) weeks before screening.
    4. Prior IVT treatment with anti-VEGF in the study eye:
    a. Last injection with ranibizumab or bevacizumab within four (4) weeks before screening.
    b. Last injection with aflibercept or brolucizumab within eight (8) weeks before screening.
    c. Last injection with faricimab within twelve (12) weeks before screening.
    5. Prior ocular treatment with steroids in the study eye:
    a. Last injection (intra or periocular) with TA within three (3) months before screening.
    b. Last injection (IVT) with dexamethasone implant (Ozurdex®) within six (6) months before screening.
    c. Prior treatment with longer duration implants (e.g., fluocinolone acetonide IVT implant, Iluvien®) is not allowed.
    d. Prior treatment with suprachoroidal steroids is not allowed.
    6. Concurrent use of systemic glucocorticoid medications or systemic steroids within twelve (12) weeks before screening. Intranasal, inhaled, and topical orticosteroids are allowed.
    7. Prior IVT or suprachoroidal treatment with investigational agents in either eye (e.g., agents with anti-VEGF activity, or combined pharmacologic activity, gene herapies, cell therapies, or any other therapeutic medicinal product, at any time).
    8. History of vitreoretinal surgery (including surgery for retinal detachment or scleral buckle) in the study eye.
    9. Treatment with ocriplasmin (Jetrea®), in the study eye, at any time.
    10. History of retinal detachment in the study eye.
    11. IOP = 22 mmHg, uncontrolled ocular hypertension, or glaucoma (open-angle) in the study eye, treated with more than two (2) topical hypotensive medication.
    12. IOP <6mmHg (hypotony) in the study eye.
    13. History of closed-angle glaucoma in the study eye.
    14. Spherical equivalent of the refractive error of -6 diopters of myopia or worse (before cataract or refractive surgery) at screening in the study eye.
    15. Any other previous ophthalmic surgeries, uncomplicated cataract surgery, or trauma in the study eye within twelve (12) weeks before screening.
    16. Visually significant cataract in the study eye at screening.
    17. Inability to obtain planned imaging assessments due to media opacity, allergy to fluorescein, or any other reasons in the study eye.
    18. History of recurrent or active intraocular inflammation/infection in either eye (e.g., uveitis).
    19. Infectious eye disease like infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye within four (4) weeks of screening.
    20. Active malignancy or history of malignancy within the past five (5) years.
    21. Persons who are pregnant or breastfeeding at the screening visit, or who test positive for pregnancy at the screening visit or are unwilling to use adequate birth control methods to prevent pregnancy throughout the study.
    22. History of other diseases, metabolic dysfunction, physical examination, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational medication, that might affect the interpretation of the study results, or that renders the patient at high risk for treatment complications.
    23. Any other reason that in the opinion of the investigator would preclude adherence to the scheduled visits or safe participation in the study or affect the result of the study.
    1. Altra condizione oculare nell'occhio dello studio che, a parere dello sperimentatore, l'acuità visiva potrebbe non migliorare dalla risoluzione dell'edema maculare (ad es., atrofia foveale, anomalie del pigmento o cause non retiniche).
    2. Retinopatia diabetica proliferativa attiva (PDR) o sequele di PDR (inclusi neovascolarizzazione dell'iride, emorragia del vitreo o distacco di retina trazionale) allo screening nell'occhio dello studio.
    3. Fotocoagulazione pan-retinica (PRP) o fotocoagulazione laser maculare nell'occhio dello studio eseguita entro sedici (16) settimane prima dello screening.
    4. Tratt. IVT precedente con anti-VEGF nell'occhio dello studio:
    a) Ultima iniezione con ranibizumab o bevacizumab entro quattro (4) settimane prima dello screening.
    b) Ultima iniezione con aflibercept o brolucizumab entro otto (8) settimane prima dello screening.
    c) Ultima iniezione con faricimab entro dodici (12) settimane prima dello screening.
    5. Tratt. oculare precedente con steroidi nell'occhio dello studio:
    a) Ultima iniezione (intra o perioculare) con TA entro tre (3) mesi prima dello screening.
    b) Ultima iniezione (IVT) con impianto di desametasone (Ozurdex®) entro sei (6) mesi prima dello screening.
    c) Tratt. precedente con impianti di durata maggiore (ad es. impianto IVT con fluocinolone acetonide, Iluvien®).
    d) Precedente tratt. con steroidi sopra coroideali.
    6. Uso concomitante di farmaci glucocorticoidi sistemici o steroidi sistemici entro dodici (12) settimane prima dello screening. Sono ammessi corticosteroidi intranasali, inalatori e topici.
    7. Precedente IVT o tratt. sopra coroideale con agenti sperimentali in entrambi gli occhi (ad es. agenti con attività anti-VEGF o attività farmacologica combinata, terapie geniche, terapie cellulari o qualsiasi altro medicinale terapeutico, in qualsiasi momento).
    8. Chirurgia vitreo-retinica (inclusa la chirurgia per distacco di retina o fibbia sclerale) nell'occhio dello studio.
    9. Tratt. con ocriplasmina (Jetrea®), nell'occhio dello studio.
    10. Storia di distacco di retina nell'occhio dello studio.
    11. IOP = 22 mmHg, ipertensione oculare non controllata o glaucoma (angolo aperto) nell'occhio dello studio, trattati con più di due (2) farmaci ipotensivi topici.
    12. IOP <6mmHg (ipotonia) nell'occhio dello studio.
    13. Storia di glaucoma ad angolo chiuso nell'occhio dello studio.
    14. Equivalente sferico dell'errore di rifrazione di =6 diottrie di miopia (prima della cataratta o della chirurgia refrattiva) nell'occhio dello studio allo screening.
    15. Precedente intervento chirurgico oftalmico, intervento chirurgico di cataratta non complicato o trauma nell'occhio oggetto dello studio entro dodici (12) settimane prima dello screening.
    16. Cataratta visivamente significativa nell'occhio dello studio allo screening.
    17. Incapacità di ottenere valutazioni di imaging pianificate a causa dell'opacità dei media, di allergia alla fluoresceina o di qualsiasi altro motivo nell'occhio dello studio.
    18. Storia di infiammazione/infezione intraoculare ricorrente o attiva in entrambi gli occhi (ad es. uveite).
    19. Malattie oculari infettive come blefarite infettiva, cheratite, sclerite o congiuntivite in entrambi gli occhi entro quattro (4) settimane dallo screening.
    20. Neoplasia maligna attiva o storia di neoplasia maligna negli ultimi cinque (5) anni.
    21. Donne in gravidanza o allattamento o non disposte a utilizzare metodi contraccettivi adeguati.
    22. Anamnesi positiva per altre malattie, disfunzioni metaboliche, esami fisici o reperti clinici di laboratorio che diano il ragionevole sospetto di una malattia o condizione che controindichi l'uso di un farmaco sperimentale, che potrebbero influenzare l'interpretazione dei risultati dello studio o che rendano il paziente ad alto rischio di complicanze al trattamento.
    23. Qualsiasi altro motivo che, a parere dello sperimentatore, precluda il rispetto delle visite programmate o influenzi il risultato dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is safety and tolerability as assessed by:
    1. Frequency of ocular and systemic adverse events (serious [SAEs] and treatment-emergent non-serious adverse events [TEAEs]).
    2. Frequency of adverse device effects (ADEs, serious ADEs [SADEs]).
    L’endpoint primario di sicurezza e tollerabilità di questo studio è valutato attraverso:
    1. Frequenza degli eventi avversi oculari e sistemici (seri [SAEs] ed eventi avversi non-seri emergenti da trattamento [TEAEs]).
    2. Frequenza degli eventi avversi da Presidio (ADEs, ADEs seri [SADEs]).
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 Weeks
    24 Settimane
    E.5.2Secondary end point(s)
    Mean Change in BCVA (ETDRS) at study visits through Week 24 compared to baseline; Percentage of participants with vision gain and vision loss of at least 5, at least 10, and at least 15 letters at all visits through Week 24 compared to baseline.; Time to subjects meeting criteria for follow-on treatment (per pre-specified criteria).; Mean Change in Central subfield thickness (CST) at study visits through Week 24 compared to baseline.; Mean Change in Retinal subfield thickness (RST) for each ETDRS subfield.; Mean Change in IOP at all study visits through Week 24 compared to baseline
    Cambiamento medio di BCVA (ETDRS) ad ogni visita dello studio, fino alla settimana 24 in confronto a quella basale.; Percentuale di partecipanti con miglioramento o peggioramento del visus di almeno 5, almeno 10 e almeno 15 lettere a tutte le visite, fino alla settimana 24, in confronto a quella basale.; Tempo impiegato dai soggetti per soddisfare i criteri per un trattamento successivo (secondo criteri predefiniti).; Cambiamento medio dello spessore del sottocampo centrale (CST) a tutte le visite fino alla settimana 24, rispetto a quella basale.; Cambiamento medio dello spessore del sottocampo retinico (RST) per ciascun sottocampo ETDRS.; Cambiamento medio di IOP a tutte le visite fino alla settimana 24, rispetto a quella basale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 Weeks; 24 Weeks; 4 weeks; 24 Weeks; NA; 24 Weeks
    24 Settimane; 24 Settimane; 4 Settimane; 24 Settimane; NA; 24 Settimane
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Participants’ fellow eyes may continue to receive non-study treatment following guidelines and standards at the investigational site. Treatment of the fellow eye is not
    considered part of the study treatment.
    Per i pazienti che hanno mostrato una risposta positiva al trattamento (a giudizio dello sperimentatore in accordo con il monitor medico), può essere considerata la continuazione del trattamento con Triesence® utilizzando il microcatetere Oxulumis®. Il dispositivo Oxulumis® può essere fornito in questo caso alCentro in base al paziente al di fuori di un'indagine clinica. I pazienti che non hanno mostrato una rispsta positiva al trattamento saranno gestiti secondo gli standard di cura locali.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-07-01
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