Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-003079-31
    Sponsor's Protocol Code Number:QRK207
    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:2020-11-04
    Trial results View 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 number2015-003079-31
    A.3Full title of the trial
    A PHASE 2/3, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED TRIAL OF QPI-1007 DELIVERED BY SINGLE OR MULTI-DOSE INTRAVITREAL INJECTION(S) TO SUBJECTS WITH ACUTE NONARTERITIC ANTERIOR ISCHEMIC OPTIC NEUROPATHY (NAION)
    Sperimentazione di Fase 2/3, randomizzata, in doppio cieco, controllata verso Sham di QPI-1007 somministrato mediante una o pi¿ iniezioni intravitreali monodose o multidose a soggetti con neuropatia ottica ischemica anteriore non arteritica (NAION) acuta
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A TRIAL OF QPI-1007 DELIVERED BY SINGLE OR MULTI-DOSE INTRAVITREAL INJECTION(S) TO SUBJECTS WITH ACUTE OPTIC NEUROPATHY (NAION)
    Sperimentazione di QPI-1007 somministrato mediante una o pi¿ iniezioni intravitreali monodose o multidose a soggetti con neuropatia ottica acuta(NAION)
    A.3.2Name or abbreviated title of the trial where available
    A TRIAL OF QPI-1007 DELIVERED BY SINGLE OR MULTI-DOSE INTRAVITREAL INJECTION(S) TO SUBJECTS WITH ACU
    Sperimentazione di QPI-1007 somministrato mediante una o pi¿ iniezioni intravitreali monodose o mult
    A.4.1Sponsor's protocol code numberQRK207
    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 SponsorQUARK PHARMACEUTICALS, INC.
    B.1.3.4CountryUnited States
    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 supportQuark Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuark Pharmaceuticals Inc.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address6501 Dumbarton Circle
    B.5.3.2Town/ cityFremont CA
    B.5.3.3Post codeCA 94555
    B.5.3.4CountryUnited States
    B.5.4Telephone number000000
    B.5.5Fax number000000
    B.5.6E-mailno@email.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 No
    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 name-
    D.3.2Product code [QPI-1007 30mg/ml]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1231741-17-5
    D.3.9.2Current sponsor codeQPI-1007
    D.3.9.4EV Substance CodeSUB179403
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 No
    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.IMP: 2
    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 No
    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 name-
    D.3.2Product code [QPI-1007 60mg/ml]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1231741-17-5
    D.3.9.2Current sponsor codeQPI-1007
    D.3.9.4EV Substance CodeSUB179403
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 No
    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
    NAION typically presents as an abrupt, painless monocular vision loss. Visual loss varies widely, ranging from visual field loss only to complete blindness. The neuronal degeneration process in NAION is thought to occur as primary retinal ganglion cell (RGC) axonal and glial damage from ischemia; Damage to RGC axons causes retrograde death of the associated RGC soma by apoptosis, Neuroprotection of partially damaged RGCs would further limit the loss of visual function.
    La NAION si presenta tipicamente come un'improvvisa ed indolore perdita della vista monoculare. La perdita della vista varia di molto, che va dalla perdita del solo campo visivo fino alla completa cecita'. Il processo di degenerazione neuronale nella NAION si ritiene che si verifichi con una lesione assonale e gliale alle cellule gangliari della retina (RGC) primaria causata da ischemia; la lesione assonale delle RCG causa la morte retrograda del soma associato alle RGC per apoptosi.
    E.1.1.1Medical condition in easily understood language
    Opthic neuropathies represent unmet medical needs.
    Neuroprotection of partially damaged RGCs (retinal ganglion cells ) would further limit the loss of visual function.
    Le neuropatie ottiche rappresentano delle necessit¿ mediche insoddisfatte.
    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 10068242
    E.1.2Term Nonarteritic anterior ischaemic optic neuropathy
    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
    1. To assess the safety and tolerability of QPI-1007 IVT injections in subjects with recent-onset NAION.
    2. To determine the effect on visual function of QPI-1007 IVT injections in subjects with recent-onset NAION.
    1. Valutare la sicurezza e la tollerabilit¿ di iniezioni intravitreali (IVT) di QPI-1007 in soggetti con neuropatia ottica ischemica anteriore non arteritica (NAION) di recente insorgenza.
    2. Determinare l¿effetto sulla funzione visiva di iniezioni IVT di QPI-1007 in soggetti con NAION di recente insorgenza.
    E.2.2Secondary objectives of the trial
    To evaluate the structural changes in the peripapillary retinal nerve fiber layer (pRNFL) and ganglion cell layer following administration of QPI-1007 in subjects with recent-onset NAION.
    1. Valutare i mutamenti strutturali nello strato delle fibre nervose retiniche peripapillari (RNFL) e nello strato delle cellule gangliari dopo la somministrazione di QPI-1007 in soggetti con NAION di recente insorgenza.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Positive diagnosis of first episode of NAION in the study eye, with symptom onset within 14 days prior to Day 1. The NAION diagnosis requires all of the following:
    • Disc edema (observed and documented at the study site)
    • Visual field defects in the study eye consistent with optic neuropathy and mean deviation worse than -3.0 dB on Humphrey standard automated perimetry using theSITA standard 24-2 testing protocol
    • Relative afferent pupillary defect (unless the contralateral eye had previous NAION
    or other optic nerve or retinal disease that is not an exclusion criterion)OCT image and VF pattern compatible with the diagnosis of NAION, as determined by a Central Reading Center.
    2.-Subject is 50 to 80 years of age.
    3.-Best-corrected visual acuity score in the study eye is better than or equal to 15 letter score, measured using the ETDRS visual acuity protocol at Day 1 prior to study drug administration/sham procedure
    4.-Clear ocular media and able to undergo adequate pupil dilation to allow a good fundus examination in the study eye.
    1. Diagnosi positiva del primo episodio della NAION nell’occhio in studio, con insorgenza dei sintomi entro i 14 giorni precedenti il Giorno 1. La diagnosi di NAION richiede tutti i seguenti elementi:
    • Papilledema (osservato e documentato presso il centro dello studio)
    • Difetti del campo visivo nell’occhio in studio coerenti con neuropatia ottica e significativi di una deviazione media peggiore di -3,0 dB nella perimetria automatizzata standard di Humphrey utilizzando il protocollo di valutazione SITA Standard 24-2
    •Relativo difetto pupillare afferente (a meno che l’occhio controlaterale sia affetto da pregressa NAION o altra patologia del nervo ottico o della retina che non sia un criterio di esclusione)
    • Immagine di tomografia ottica a radiazione coerente (OTC) e modello di campo visivo (VF) compatibili con una diagnosi di NAION, come determinato da un Centro di lettura centralizzata (Central Reading Center).
    2. Il soggetto deve ave un’età compresa tra 50-80 anni.
    3. Il miglior punteggio di correzione dell’acuita visiva nell’occhio in studio deve essere migliore o uguale a un punteggio di 15 lettere, misurato utilizzando il protocollo di acuità visiva dello Studio del trattamento precoce della retinopatia diabetica (ETDRS) al Giorno 1 prima della somministrazione del farmaco dello studio/procedura Sham.
    4. Membrana media del bulbo oculare trasparente e capacità di sottoporsi a un’adeguata dilatazione della pupilla per consentire un buon esame del fondo dell’occhio in studio.
    E.4Principal exclusion criteria
    1. Present use or history of any treatment for the current episode of NAION, including systemic steroids or brimonidine. Traditional Chinese herbal medicine taken for the treatment of the current episode of NAION should be discontinued.
    2. Macular disease, proliferative (or pre-proliferative) diabetic retinopathy, or other eye disease limiting visual acuity in the study eye only.
    3. Prior episode of NAION in the study eye only.
    4. Bilateral (simultaneous) NAION
    5. NAION secondary to acute blood loss (due to surgery, trauma, or spontaneoushemorrhage) or immediately following any surgery.
    6. Prior incisional or laser intraocular surgery at any time, other than corneal laser surgeries (e.g., laser-assisted in situ keratomileusis) within one month prior to, laser capsulotomy within one week prior to, or cataract surgery performed within 3 months prior to Day 1 in the study eye only.
    Note: Glaucoma laser surgery (i.e., laser iridotomy, laser iridoplasty) performed for narrow anterior chamber angle (not for ocular hypertension or glaucoma) and retinallaser surgeries for small peripheral retinal tears in the study eye, if more than 1 month prior to Day 1, are acceptable
    7.Visual Field exclusions at Screening Visit (inconclusive visual fields should be sent to the Reading Center for adjudication):
    • Less than 3 adjacent abnormal points (>0.5% significance) on the pattern deviation map and the total deviation map
    • Temporal or nasal field loss that respects vertical midline
    • Homonymous binocular field loss (other than bilateral altitudinal in a subject with prior NAION)
    • Heteronymous binocular field loss that is bitemporal
    • Only abnormality on the field is an enlarged blind spot
    8. Pain on eye movement in either eye.
    9. History of vitrectomy in the study eye only
    10. History of vitreous hemorrhage in the study eye only.
    11. History of retinal detachment in the study eye only
    12. History of optic neuritis in either eye.
    13. History of uveitis in either eye.
    14. Any active inflammatory condition in the study eye only (e.g., scleritis, uveitis).
    15. Any active infectious condition (e.g., conjunctivitis) in either eye.
    16. Glaucoma or ocular hypertension in the study eye only.
    17. Intraocular pressure (IOP) greater than 25 mmHg on Day 1 prior to masked study drug administration in the study eye only.
    18. Present use of drugs known to cause optic nerve or retinal toxicity atDay 1/Randomization, such as:
    chloroquine or hydroxychloroquine, ethambutol, Vigabatrin. Subjects who need to be prescribed any of these drugs during the course of the study will be discontinued from the trial.
    19. Any other abnormality that, in the opinion of the Investigator, is suggestive of a disease other than NAION in the study eye only.
    1. Utilizzo attuale o anamnesi di qualsiasi trattamento per l’episodio corrente di NAION, tra cui steroidi sistemici o brimonidina. L’assunzione di medicinali fitoterapici della medicina tradizionale cinese per il trattamento dell’episodio corrente di NAION deve essere interrotta.
    2. Malattia maculare, retinopatia diabetica proliferativa (o pre-proliferativa) o altre patologie oculari che limitino l’acuità visiva nel solo occhio in studio.
    3. Pregresso episodio di NAION nel solo occhio in studio.
    4. NAION bilaterale (simultanea).
    5. NAION secondaria a perdita acuta di sangue (a causa di intervento chirurgico, traumi o emorragia spontanea) o immediatamente dopo qualsiasi intervento chirurgico.
    6. Precedente intervento chirurgico intraoculare incisionale o al laser, in qualsiasi momento, diverso dalla chirurgia laser corneale (ad esempio, cheratomileusi in situ laser assistita) entro il mese precedente, capsulotomia laser entro una settimana precedente o intervento chirurgico della cataratta eseguito entro i 3 mesi precedenti al Giorno 1 nel solo occhio in studio. Nota: l’intervento chirurgico al laser per il glaucoma (ossia, iridotomia laser, iridoplastica laser) eseguito per l’angolo della camera anteriore stretta (non per ipertensione oculare o glaucoma) e l’intervento chirurgico al laser della retina per le piccole lesioni retiniche periferiche nell’occhio in studio, se eseguiti più di 1 mese prima del Giorno 1, sono accettabili.
    7. Le esclusioni per i campi visivi alla Visita di screening (i campi visivi inconcludenti devono essere inviati al Centro di lettura per la validazione):
    ¿ Meno di 3 punti adiacenti anormali (> 0,5% di significatività) sulla mappa di deviazione dal modello e sulla mappa deviazione totale
    ¿ Perdita del campo visivo temporale o nasale che rispetti la linea mediana verticale
    ¿ Perdita di campo visivo binoculare omonimo (diverso da altitudinale bilaterale in un soggetto con pregressa NAION)
    ¿ Perdita di campo visivo binoculare eteronoma che sia bitemporale
    ¿ Solo l’anomalia sul campo è un punto cieco allargato
    8. Dolore al movimento degli occhi in uno o in entrambi gli occhi.
    9. Anamnesi di vitrectomia nel solo occhio in studio.
    10. Anamnesi di emorragia vitreale nel solo occhio in studio.
    11. Anamnesi di distacco retinico nel solo occhio in studio.
    12. Anamnesi di neurite ottica in uno o in entrambi gli occhi.
    13. Anamnesi di uveite in uno o in entrambi gli occhi.
    14. Qualsiasi condizione infiammatoria attiva nel solo occhio in studio (ad esempio, sclerite, uveite).
    15. Qualsiasi condizione infettiva attiva (ad esempio, congiuntivite) in uno o in entrambi gli occhi.
    16. Glaucoma o ipertensione oculare nel solo occhio in studio.
    17. Pressione intraoculare (IOP) superiore a 25 mmHg al Giorno 1 prima della somministrazione in cieco del farmaco dello studio nel solo occhio in studio.
    18. Assunzione attuale di farmaci noti per causare tossicità del nervo ottico o retinica al Giorno 1/alla Randomizzazione, come: clorochina o idrossiclorochina, etambutolo, Vigabatrin. I soggetti che necessitano della prescrizione di uno di questi farmaci durante il corso dello studio saranno interrotti dalla sperimentazione.
    19. Qualsiasi altra anomalia che, secondo l’opinione dello Sperimentatore, sia indicativa di una malattia diversa dalla NAION nel solo occhio in studio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of subjects who lose 15
    letters or more in best corrected visual acuity (BCVA) score from
    Baseline (Day 1/Randomization) to Month 12.
    • The primary safety endpoint is safety and tolerability of QPI-1007 in
    recent-onset NAION.
    L’endpoint primario di efficacia è la percentuale di soggetti con perdita di 15 o più lettere nel miglior punteggio di correzione dell’acuita visiva (BCVA) ottenuto dal Basale (Giorno 1/Randomizzazione) al Mese 12.
    • L’endpoint primario di sicurezza è la sicurezza e la tollerabilità di QPI-1007 nella NAION di recente insorgenza.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The proportion of subjects losing at least 15 letters in BCVA will be compared among each QPI-1007 treatment group and the control group using the exact multiple logistic regression test. Separate comparisons will be made for the four active treatment groups vs. the sham control group. The analysis will be performed on the mITT population
    La percentuale di soggetti con una perdita di almeno 15 lettere nel punteggio BCVA sarà confrontata tra ciascun gruppo di trattamento con QPI-1007 e il gruppo di controllo utilizzando il test di regressione logistica multipla esatto. Confronti separati saranno effettuati per i quattro gruppi di trattamento attivo rispetto al gruppo di controllo Sham. L’analisi viene condotta sulla popolazione mITT
    E.5.2Secondary end point(s)
    1. Mean change from Day 1 to Month 12
    in BCVA letter score, as measured by ETDRS visual acuity protocol in the study eye.
    2. Mean change of Visual Fields; mean deviation from Day 1 to Month 12 as assessed by Humphrey standard automated perimetry using the SITA standard 24-2 testing protocol in the study eye.
    1. Variazione media dal Giorno 1 al Mese 12 nel punteggio BCVA delle lettere, come misurato
    mediante il protocollo ETDRS di acuit¿ visiva nell¿occhio in studio.
    2. Variazione media del campo visivo; significa una deviazione dal Giorno 1 al Mese 12 come valutata mediante perimetria automatizzata standard di Humphrey utilizzando il protocollo di valutazione SITA Standard 24-2 nell¿occhio in studio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For the analysis of the key secondary efficacy endpoints, a step-down sequential testing procedure will be used to control the overall type 1 error at 0.05. With this procedure, the primary and two key secondary efficacy endpoints will be evaluated for statistical significance based on a pre-specified sequence for interpretation.
    1. Mean change from Day 1 to Month 12 in BCVA score, as measured by ETDRS visual acuity protocol in the study eye.
    2. Mean change of Visual Fields; mean deviation from Day 1 to Month 12 as assessed by Humphrey standard automated perimetry using the SITA standard 24-2 testing protocol in the study eye.
    Per l¿analisi dei principali endpoint secondari di efficacia, una procedura di
    valutazione sequenziale con approccio a scalare (¿step-down¿) viene utilizzata per controllare l¿errore complessivo di Tipo 1 allo
    0,05. Con questa procedura, l¿endpoint primario e i due principali endpoint secondari di efficacia saranno valutati per la
    significativit¿ statistica sulla base di una sequenza pre-specificata ai fini dell¿interpretazione.
    1. Variazione media dal Giorno 1 al Mese 12 nel punteggio BCVA, come misurato mediante il protocollo ETDRS di acuit¿ visiva
    nell¿occhio in studio.
    2. Per variazione media del campo visivo si intende la sensibilit¿ dal Giorno 1 al Mese 12, valutata mediante perimetria automatizzata standard di Humphrey utilizzando la strategia di soglia piena e uno ..
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    La procedura Sharm (siringa sterile vuota senza ago) a contatto con la superficie oculare per mimare
    Sham procedure (needleless empty sterile syringe) touched to the surface of the eye to mimic IVT
    E.8.2.4Number of treatment arms in the trial5
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    China
    Germany
    India
    Israel
    Italy
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Last visit of the last patient
    Ultima visita dell'ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 93
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 372
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 820
    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)
    None
    Nessuno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Neuro Ophtalmology Research Disease Investigator Consortium NORDIC
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 02 08:24:48 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA