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    Summary
    EudraCT Number:2020-000676-38
    Sponsor's Protocol Code Number:ISEE2008
    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:2020-10-21
    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 number2020-000676-38
    A.3Full title of the trial
    A Phase 3 Multicenter, Randomized, Double Masked, Sham-Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura™ (Complement C5 Inhibitor) in Patients with Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
    Studio clinico di fase III multicentrico, randomizzato, in doppio cieco, controllato con trattamento simulato, volto a valutare la sicurezza e l’efficacia della somministrazione intravitreale di Zimura™ (inibitore del componente C5 del complemento) in pazienti con atrofia geografica secondaria a degenerazione maculare senile secca
    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 Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
    Studio clinico per valutare la sicurezza e l’efficacia della somministrazione intravitreale di Zimura in soggetti con atrofia geografica secondaria a degenerazione maculare senile secca
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberISEE2008
    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 supportIVERIC bio, Inc.
    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 pointVP, Global Regulatory Affairs
    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 number0018625798283
    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.3.9.4EV 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
    geographic atrophy secondary to dry age-related macular degeneration
    atrofia geografica secondaria a degenerazione maculare senile secca
    E.1.1.1Medical condition in easily understood language
    geographic atrophy secondary to dry age-related macular degeneration
    atrofia geografica secondaria a degenerazione maculare secca legata all'età
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10075567
    E.1.2Term Dry age-related macular degeneration
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    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 administration in patients with geographic atrophy secondary to dry age-related macular degeneration (AMD)
    Gli obiettivi di questo studio riguardano la valutazione della sicurezza e dell’efficacia della somministrazione intravitreale di Zimura in pazienti con atrofia geografica secondaria a degenerazione maculare senile secca (Age-related Macular Degeneration, AMD)
    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 (SE):
    - Non-foveal GA secondary to dry AMD.
    - The atrophic lesion must be able to be photographed in its entirety.
    - Best corrected visual acuity in the SE between 20/25 – 20/320, inclusive.

    General Inclusion Criteria
    - Patients of either gender aged >= 50 years.
    - Women of non-childbearing potential is defined as follows:
    • Woman who has had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy)
    • Woman >= 60 years of age
    • Woman >= 40 and =< 60 years of age who fulfills at least one of the following
    o A cessation of menses for at least 12 months and a folliclestimulating hormone (FSH) test confirming non-childbearing potential (refer to laboratory reference ranges for confirmatory levels)
    o A cessation of menses for at least 24 months without FSH levels confirmed

    For patients who are women of childbearing potential involved in any sexual intercourse that could lead to pregnancy, the patient has used a protocol approved highly effective contraceptive method during the trial and agrees to continue the same method until at least 90 days following the last dose of test medication. Protocol approved highly effective contraceptive methods are hormonal contraceptives (i.e., combined oral contraceptive, patch, vaginal ring, injectable, or implant), intrauterine devices or intrauterine systems, abstinence as defined by refraining from heterosexual intercourse during the entire period of the study and until at least 90 days following the last dose of study medication, vasectomy, and tubal ligation.
    If patient is a woman of childbearing potential, she must have a negative serum pregnancy test within 14 days prior to the first injection and have no plans to donate ova during the duration of the trial and at least 90 days following the last dose of test medication.
    If patient is a male, the patient should use condom and not donate sperm 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 for the 24-month duration of the study.

    ...
    PLEASE REFER TO THE STUDY PROTOCOL FOR THE COMPLETE LIST OF INCLUSION CRITERIA
    Criteri di inclusione oftalmici
    I seguenti criteri di inclusione si applicano all’occhio di studio (Study Eye, SE):
    - GA non foveale secondaria ad AMD secca.
    - La lesione atrofica deve poter essere fotografata interamente.
    - Migliore acuità visiva corretta nello SE compresa tra 20/25 e 20/320, entrambi inclusi.

    Criteri di inclusione generali
    - Pazienti di ambo i sessi di età >= 50 anni.
    - Le donne non potenzialmente fertili sono definite come segue:
    • Donna sottoposta a sterilizzazione chirurgica (isterectomia, ooforectomia bilaterale o salpingectomia bilaterale)
    • Donna di età >= 60 anni
    • Donna di età >= 40 e =<60 anni che soddisfa almeno uno dei seguenti requisiti:
    o Scomparsa delle mestruazioni da almeno 12 mesi e conferma della non potenziale fertilità mediante test dell’ormone follicolo-stimolante (FSH) (per i livelli di conferma fare riferimento agli intervalli di riferimento del laboratorio)
    o Scomparsa delle mestruazioni da almeno 24 mesi senza livelli dell’FSH confermati

    Per le pazienti potenzialmente fertili che hanno avuto qualsiasi rapporto sessuale che potrebbe portare a una gravidanza, la paziente ha utilizzato un metodo contraccettivo altamente efficace approvato secondo il protocollo durante lo studio e si impegna a continuare ad utilizzare lo stesso metodo fino ad almeno 90 giorni dopo l’ultima dose del farmaco in studio. I metodi contraccettivi altamente efficaci approvati secondo il protocollo sono i contraccettivi ormonali (cioè contraccettivi orali combinati, cerotto, anello vaginale e contraccettivi iniettabili o impiantabili), i dispositivi o i sistemi intrauterini, l’astinenza, definita come l’astensione dai rapporti eterosessuali durante l’intero periodo dello studio e fino ad almeno 90 giorni dopo l’ultima dose del farmaco in studio, la vasectomia e la legatura delle tube.
    Se la paziente è una donna potenzialmente fertile, deve presentare un test di gravidanza sul siero negativo nei 14 giorni precedenti alla prima iniezione e non avere in programma di donare ovuli durante lo studio e fino ad almeno 90 giorni dopo l’ultima dose del farmaco in studio.
    Se il paziente è un uomo, deve utilizzare il preservativo e non deve donare sperma durante il periodo di esposizione al farmaco in studio e per i 90 giorni successivi all’ultima esposizione al farmaco in studio.

    - Fornire il consenso informato scritto.
    - Capacità di sottoporsi a tutte le visite dello studio nell’arco dei 24 mesi di durata dello studio.

    ...
    PER L'ELENCO COMPLETO DEI CRITERI DI INCLUSIONE, SI PREGA DI FARE RIFERIMENTO AL PROTOCOLLO DI STUDIO
    E.4Principal exclusion criteria
    Patients will not be eligible for the trial if patients cannot attend all trial required visits, or if any of the following criteria are present systemically or in the SE:
    Ophthalmic Exclusion Criteria
    The following exclusion criteria apply to the SE:
    Evidence of CNV in either eye.
    - Any prior treatment for AMD (dry or wet) or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals.
    - Any ocular condition in the SE that would progress during the course of the study that could affect central vision or otherwise be a confounding factor.
    - Presence of other causes of choroidal neovascularization
    - 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 (including blepharitis), or ocular surface inflammation in the past 12 weeks.
    - Any sign of diabetic retinopathy in either eye.

    ...
    PLEASE REFER TO THE STUDY PROTOCOL FOR THE COMPLETE LIST OF EXCLUSION CRITERIA
    I pazienti non saranno idonei alla sperimentazione se non possono partecipare a tutte le visite richieste o se uno dei seguenti criteri è presente a livello sistemico o nello SE:
    Criteri di esclusione oftalmici:
    I seguenti criteri di esclusione si applicano allo SE:
    - Evidenza di neovascolarizzazione coroideale (Choroidal NeoVascularization, CNV) in qualsiasi occhio.
    - Qualsiasi trattamento precedente per l’AMD (secca o umida) o qualsiasi precedente trattamento intravitreale per qualunque indicazione in qualsiasi occhio, fatta eccezione per gli integratori orali a base di vitamine e minerali.
    - Qualsiasi condizione oculare nello SE che potrebbe progredire durante lo studio e quindi incidere sulla visione centrale o altrimenti rappresentare un fattore confondente.
    - Presenza di altre cause di neovascolarizzazione coroideale.
    - 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 (inclusa la blefarite) o infiammazione della superficie oculare nelle ultime 12 settimane.
    - Qualunque segno di retinopatia diabetica in qualsiasi occhio.

    ...
    PER L'ELENCO COMPLETO DEI CRITERI DI ESCLUSIONE, SI PREGA DI FARE RIFERIMENTO AL PROTOCOLLO DI STUDIO
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint:
    Mean rate of change in GA over 12 months measured by FAF at three time points:
    Baseline, Month 6 and Month 12 (square root transformation)

    Safety Endpoints:
    • AEs
    • Vital signs (pulse, systolic and diastolic blood pressure)
    • Ophthalmic variables (BCVA, LLBCVA, IOP, and ophthalmic examination)
    • ECG (12-lead)
    • Laboratory variables (blood: hematology, renal function, hepatic function, and electrolytes; urinalysis)
    Endpoint primario di efficacia:
    Tasso di variazione medio dell’atrofia geografica (Geographic Atrophy, GA) nel corso di 12 mesi misurato mediante autofluorescenza del fondo oculare (Fundus AutoFluorescence, FAF) in tre punti temporali:
    Basale, Mese 6 e Mese 12 (trasformazione in radice quadrata)

    Endpoint di sicurezza:
    • Eventi avversi (Adverse Events, AE)
    • Segni vitali (frequenza cardiaca, pressione arteriosa sistolica e diastolica)
    • Risultati oftalmici (migliore acuità visiva corretta [Best Corrected Visual Acuity, BCVA], BCVA a bassa luminanza, pressione intraoculare [Intraocular Pressure, IOP] ed esame oftalmologico)
    • Elettrocardiogramma (ECG) (a 12 derivazioni)
    • Variabili di laboratorio (sangue: ematologia, funzionalità renale, funzionalità epatica ed elettroliti; analisi delle urine)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Month 6 and Month 12
    Basale, Mese 6 e Mese 12
    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) No
    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
    Zimura e il trattamento simulato sono somministrati da uno sperimentatore non in cieco
    Zimura and sham administered by an unmasked investigator
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA58
    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
    Argentina
    Australia
    Brazil
    Canada
    Colombia
    Croatia
    Czech Republic
    Estonia
    France
    Germany
    Hungary
    Israel
    Italy
    Latvia
    Poland
    Spain
    United Kingdom
    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
    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 days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 320
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 133
    F.4.2.2In the whole clinical trial 400
    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 Decision2020-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-22
    P. End of Trial
    P.End of Trial StatusCompleted
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