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    Summary
    EudraCT Number:2017-004783-35
    Sponsor's Protocol Code Number:OPH2005
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-25
    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 number2017-004783-35
    A.3Full title of the trial
    A Phase 2b Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Zimura™ (Complement C5 Inhibitor) Compared to Sham in Subjects with Autosomal Recessive Stargardt Disease
    Studio di fase IIb randomizzato, in doppio cieco e controllato volto a stabilire la sicurezza e l'efficacia di Zimura™ (inibitore del componente C5 del complemento) rispetto al trattamento fittizio in soggetti affetti da malattia di Stargardt autosomica recessiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura in Subjects with Autosomal Recessive Stargardt Disease
    Una sperimentazione clinica per valutare la sicurezza e l'efficacia della somministrazione intravitreale di Zimura in soggetti con malattia stargardt autosomica recessiva
    A.3.2Name or abbreviated title of the trial where available
    A Clinical Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura in Subj
    Una sperimentazione clinica per valutare la sicurezza e l'efficacia della somministrazione intravitr
    A.4.1Sponsor's protocol code numberOPH2005
    A.5.4Other Identifiers
    Name:OPH2005Number:OPH2005
    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 SponsorIVERIC bio, 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 supportOPHTHOTECH CORPORATION
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIVERIC BIO, Inc.
    B.5.2Functional name of contact pointKenneth Miller
    B.5.3 Address:
    B.5.3.1Street AddressOne Penn Plaza, 35th floor, Suite 3520
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10119
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016467538468
    B.5.5Fax number000000
    B.5.6E-mailkenneth.miller@ivericbio.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 nameZimura
    D.3.2Product code [ARC1905]
    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.3.8INN - Proposed INNavacincaptad pegol
    D.3.9.2Current sponsor codeARC1905
    D.3.9.3Other descriptive nameARC1905
    D.3.9.4EV Substance CodeSUB30770
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Autosomal Recessive Stargardt Disease
    Malattia di Stargardt autosomica recessiva
    E.1.1.1Medical condition in easily understood language
    Autosomal Recessive Stargardt Disease
    malattia di Stargardt autosomica recessiva
    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 PT
    E.1.2Classification code 10062766
    E.1.2Term Stargardt's disease
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this study are to evaluate the safety and efficacy of Zimura™ intravitreal injection compared to Sham in subjects with autosomal recessive Stargardt disease 1 (STGD1).
    Gli obiettivi del presente studio sono valutare la sicurezza e l'efficacia di Zimura™ somministrato mediante iniezione intravitreale rispetto al trattamento fittizio in soggetti affetti da malattia di Stargardt di tipo 1 (Stargardt Disease 1, STGD1) autosomica recessiva.
    E.2.2Secondary objectives of the trial
    Not applicable
    non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Ophthalmic Inclusion Criteria
    The following inclusion criteria apply to the study eye:
    - At least two pathogenic mutations of ABCA4 gene confirmed by a CLIA-certified laboratory.
    - Best corrected visual acuity in the study eye between 20/20 - 20/200 Snellen equivalent, inclusive.
    - Presence of at least one identifiable location of at least 250 micrometers contiguous width of ellipsoid zone loss on SD-OCT within the total 9 ETDRS subfields.
    - The total area of thinned layer(s) on OCT not extending beyond the outer ring of the total 9 ETDRS subfields (e.g. not extending beyond fields 5-9).
    - Fundus autofluorescence may show heterogeneous signals (areas of increased and/or decreased autofluorescence) but no area of subfoveal definitely decreased autofluorescence (DDAF).
    - Clear ocular media and adequate pupillary dilatation in both eyes (OU) to allow for all imaging procedures, including good quality stereoscopic fundus photography, fundus autofluorescence, and spectral domain ocular coherence tomography.
    - Intraocular pressure of 21 mmHg or less in the study eye.
    General Inclusion Criteria
    - Subjects of either gender aged between 18 and 50 years, inclusive.
    - Women must be using two forms of effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile; if of child-bearing potential, a serum pregnancy test must be performed within 14 days prior to the first injection with a negative result. The two forms of effective contraception must be implemented during the trial and for at least 90 days following the last dose of test medication. Male subjects should use a condom during the time of study drug exposure and for 90 days following last exposure of study drug.
    - Provide written informed consent.
    - Ability to return for all trial visits.
    Criteri di inclusione oftalmici
    I seguenti criteri di inclusione si applicano all'occhio di studio:
    ¿ Presenza di almeno due mutazioni patogene del gene ABCA4 confermate da un laboratorio con certificazione CLIA.
    ¿ Migliore acuità visiva corretta nell'occhio di studio equivalente a un valore Snellen compreso tra 20/20 e 20/200 (entrambi inclusi).
    ¿ Presenza di almeno una sede identificabile di ampiezza contigua pari a minimo 250 micrometri di perdita a carico della zona dell'ellissoide alla SD-OCT rientrante nella totalità dei 9 sottocampi dell'ETDRS.
    ¿ Area totale del/degli strato/i assottigliato/i alla OCT rientrante nell'anello esterno della totalità dei 9 sottocampi dell'ETDRS (ad es. che non si estenda oltre i campi 5-9).
    ¿ L’autofluorescenza del fondo oculare può mostrare segnali eterogenei (aree di autofluorescenza aumentata e/o ridotta) ma nessuna area di calo definito dell'autofluorescenza (Definitely Decreased Autofluorescence, DDAF) subfoveale.
    Trasparenza oculare della media e adeguata dilatazione pupillare in entrambi gli occhi (OU) tali da permettere l'esecuzione di tutte le procedure di diagnostica per immagini, ivi incluse retinografia stereoscopica di buona qualità, autofluorescenza del fondo oculare e tomografia a coerenza ottica con dominio spettrale.
    ¿ Pressione intraoculare nell'occhio di studio pari o inferiore a 21 mmHg.
    Criteri di inclusione generali
    ¿ Soggetti di entrambi i sessi e di età pari a 18-50 anni (entrambi inclusi).
    ¿ Le pazienti devono usare due metodi anticoncezionali efficaci, essere in post-menopausa da almeno 12 mesi prima dell'arruolamento nello studio o essere state sottoposte a sterilizzazione chirurgica. Se sono potenzialmente fertili, devono presentare un risultato negativo al test di gravidanza sul siero cui devono essere sottoposte entro 14 giorni prima della prima iniezione. I due metodi anticoncezionali efficaci devono essere usati durante lo studio e per almeno 90 giorni dopo la somministrazione dell'ultima dose del farmaco sperimentale. I soggetti di sesso maschile devono usare un preservativo durante il periodo di esposizione al farmaco in studio e per 90 giorni dopo l'ultima esposizione allo stesso.
    ¿ Sottoscrizione del consenso informato scritto.
    ¿ Capacità di sottoporsi a tutte le visite dello studio.
    E.4Principal exclusion criteria
    - Macular atrophy secondary to any condition other than STGD1 in either eye (e.g., drug-induced). - Any prior treatment for STGD1 including gene therapy, stem cell therapy or any prior intravitreal treatment for any indication in either eye. - Participation in an interventional study of a vitamin A derivative = 3 months prior to screening. - Any ocular condition in the study eye that would progress during the course of the study that could affect central vision, microperimetry testing or otherwise be a confounding factor. - Concomitant treatment with any ocular or systemic medication that is known to be toxic to the lens, retina or optic nerve.
    - Presence of intraocular inflammation (= trace cell or flare), macular hole, pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25mm or more), epiretinal membrane, evidence of significant vitreo-macular traction, vitreous hemorrhage or aphakia (pseudophakia with or without an intact capsule is not an exclusion criteria). - Presence or history of idiopathic or autoimmune-associated uveitis in either eye. - Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, fundus photography or fundus autofluorescence. Subjects should not be entered if there is likelihood that they will require cataract surgery in the study eye during the study. - Any intraocular surgery or thermal laser within 3 months of trial entry. Any prior thermal laser in the macular region, regardless of indication. - Any ocular or periocular infection or ocular surface inflammation in the past 12 weeks. - History of any of the following procedures: Posterior vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant or retinal detachment.
    For the "General Exclusion Criteria" see the protocol.
    Atrofia maculare secondaria a condizioni diverse dalla STGD1 in qualsiasi occhio (ad es. indotta da farmaci). • Qualsiasi trattamento precedente per la STGD1, compresi la terapia genica, la terapia con cellule staminali o qualsiasi precedente trattamento intravitreale per qualsivoglia indicazione in qualsiasi occhio. Partecipazione a uno studio interventistico su un derivato della vitamina A =3 mesi prima dello screening. • Qualsiasi condizione oculare nell’occhio di studio che potrebbe progredire durante la ricerca e quindi incidere sulla visione centrale e sui test di microperimetria o altrimenti rappresentare un fattore confondente.
    • Trattamento concomitante con qualsiasi farmaco oculare o sistemico notoriamente tossico per il cristallino, la retina o il nervo ottico. • Presenza di infiammazione intraoculare (presenza di cellule = al livello minimo o peggioramento dell’infiammazione), foro maculare, miopia patologica (equivalente sferico pari a -8 diottrie o più negativo, o lunghezza assiale pari o superiore a 25 mm), membrana epiretinica, evidenza di trazione vitreo-maculare significativa, emorragia del corpo vitreo o afachia (la pseudofachia con o senza una capsula intatta non costituisce un criterio di esclusione). • Presenza o anamnesi di uveite di origine autoimmune o idiopatica in qualsiasi occhio. • Opacità significativa della media, compresa la cataratta, che potrebbero interferire con l'acuità visiva, la valutazione della tossicità, la retinografia e l'autofluorescenza del fondo oculare. I soggetti non devono essere arruolati nello studio se è probabile che dovranno essere sottoposti a un intervento chirurgico per la cataratta nell'occhio di studio durante la ricerca. • Qualsiasi intervento chirurgico intraoculare o uso di laser termico nei 3 mesi precedenti all'ingresso nello studio. Qualsiasi precedente uso di laser termico nella regione maculare, indipendentemente dall'indicazione. • Qualsiasi infezione oculare o perioculare o infiammazione della superficie oculare nelle ultime 12 settimane. • Anamnesi di una qualsiasi delle seguenti procedure: vitrectomia posteriore, intervento chirurgico di filtraggio (ad es. trabeculectomia), intervento con dispositivo di drenaggio per il glaucoma, trapianto della cornea o distacco retinico.
    Per i "Criteri di esclusione generali" si veda il protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint
    • Mean rate of change in the area of ellipsoid zone defect measured by
    en face SD-OCT over 18 months.
    Safety Endpoints:
    • Adverse events, vital signs, ophthalmic variables [ophthalmic
    examination, intraocular pressure (IOP), fluorescein angiogram (FA),
    fundus autofluorescence (FAF), spectral domain-optical coherence
    tomography (SD-OCT), microperimetry], electrocardiogram (ECG), and
    laboratory variables.
    Endpoint di efficacia primario
    • Tasso medio di variazione dell'area del difetto nella zona dell'ellissoide misurata mediante tomografia a coerenza ottica a dominio spettrale (Spectral Domain-Optical Coherence Tomography, SD-OCT) en-face nell'arco di 18 mesi.
    Endpoint di sicurezza:
    • Eventi avversi, segni vitali, variabili oftalmiche (esame oftalmico, pressione intraoculare [Intraocular Pressure, IOP], angiografia con fluoresceina [Fluorescein Angiography, FA], autofluorescenza del fondo oculare [Fundus Autofluorescence FAF], tomografia a coerenza ottica a dominio spettrale [Spectral Domain-Optical Coherence Tomography, SD-OCT], microperimetria), elettrocardiografia (ECG) e variabili di laboratorio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Month 18
    dalla basale a 18 mesi
    E.5.2Secondary end point(s)
    Secondary and Supportive Endpoints
    • Mean rate of change in the horizontal width of undetectable ellipsoid
    zone measured by a horizontal scan through the foveal center with SDOCT
    over 18 months.
    • Mean rate of change in the area of atrophic lesion (definite decrease in
    autofluorescence, DDAF) over 18 months measured by fundus
    autofluorescence (FAF).
    • Mean change in photopic and/or mesopic macular sensitivity measured
    by microperimetry from Baseline to Month 18.
    • Mean rate of change in the thickness of the outer nuclear layer
    measured by a horizontal scan through the foveal center at the position
    of maximum width of ellipsoid zone loss at Baseline over 18 months
    measured by SD-OCT.
    • Mean change in best corrected visual acuity (Early Treatment Diabetic
    Retinopathy Study [ETDRS] letters) from Baseline to Month 18.
    • Emergence of at least one new atrophic lesion (DDAF) over 18 months
    measured by FAF at Month 18.
    Endpoint secondari e di supporto
    • Tasso medio di variazione dell'ampiezza orizzontale della zona dell'ellissoide non rilevabile, misurata mediante una scansione orizzontale attraverso il centro foveale con SD-OCT nell'arco di 18 mesi.
    • Tasso medio di variazione dell'area della lesione atrofica (calo definito dell'autofluorescenza [Definite Decrease in Autofluorescence, DDAF]) nell'arco di 18 mesi misurata mediante autofluorescenza del fondo oculare (Fundus Autofluorescence, FAF).
    • Variazione media della sensibilità maculare fotopica e/o mesopica misurata mediante microperimetria dal Baseline fino al Mese 18.
    • Tasso medio di variazione dello spessore dello strato nucleare esterno misurato mediante una scansione orizzontale attraverso il centro foveale con SD-OCT al Baseline e nell'arco di 18 mesi.
    • Variazione media della migliore acuità visiva corretta (tavola dell'Early Treatment Diabetic Retinopathy Study [ETDRS]) dal Baseline al Mese 18.
    • Insorgenza di almeno una nuova lesione atrofica (DDAF) nell'arco di 18 mesi misurata mediante FAF al Mese 18.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to Month 18
    dalla basale al mese 18
    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) No
    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
    Trattamento fittizio
    Sham
    E.8.2.4Number of treatment arms in the trial2
    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 EEA25
    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
    Canada
    Israel
    United States
    France
    Germany
    Hungary
    Italy
    Spain
    United Kingdom
    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
    LVLS
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days15
    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: 120
    F.1.3Elderly (>=65 years) No
    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 state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 120
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-05
    P. End of Trial
    P.End of Trial StatusCompleted
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    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.

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