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    Summary
    EudraCT Number:2020-000676-38
    Sponsor's Protocol Code Number:ISEE2008
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-05-10
    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 ConcernedSpain - AEMPS
    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
    Ensayo clínico de fase III multicéntrico, aleatorizado, con doble enmascaramiento y controlado con un tratamiento simulado para evaluar la seguridad y la eficacia de la administración intravítrea de Zimura™ (inhibidor del complemento C5) en pacientes con atrofia geográfica secundaria a la degeneración macular seca asociada con la edad.
    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
    Ensayo Clinico para evaluar la seguridad y eficacia de la administración intravitrea de Zimura en sujetos con Atrofia Geografica Secundaria a la degeneración macular seca asociada con la edad.
    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 number+1 862 579 8283
    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 20 MG/ML
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 geográfica secundaria a la degeneración macular seca asociada con la edad.
    E.1.1.1Medical condition in easily understood language
    Geographic atrophy secondary to dry age-related macular degeneration
    Atrofia geográfica secundaria a la degeneración macular seca asociada con la edad.
    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)
    Los objetivos de este estudio son evaluar la seguridad y la eficacia de la administración intravítrea de Zimura en pacientes con atrofia geográfica secundaria a la degeneración macular asociada a la edad (DMAE) seca.
    E.2.2Secondary objectives of the trial
    n/a
    n/a
    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 must be using two forms of effective contraception, be postmenopausal 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 60 days following the last dose of test medication.
    - Provide written informed consent.
    - Ability to return for all trial visits.
    Criterios de inclusión oftalmológicos:
    Los siguientes criterios de inclusión corresponden al ojo en estudio (OE):
    -AG no foveal secundaria a DMAE seca.
    -La lesión atrófica debe poder fotografiarse en su totalidad.
    -Mejor agudeza visual corregida en el OE entre 20/25-20/320, inclusive

    Criterios generales de inclusión:
    -Pacientes de ambos sexos de ≥50 años de edad.
    -Las mujeres deben utilizar dos métodos anticonceptivos eficaces, encontrarse en la etapa posmenopáusica al menos en los 12 meses previos a la inclusión en el ensayo clínico o ser estériles quirúrgicamente. En caso de encontrarse en edad fértil, debe obtenerse un resultado negativo en una prueba de embarazo en suero realizada en los 14 días previos a la primera inyección. Los dos métodos anticonceptivos eficaces tienen que utilizarse durante la participación en el ensayo clínico y, como mínimo, durante los 60 días posteriores a la última dosis de la medicación en estudio
    -Dar consentimiento informado por escrito.
    -Capacidad para acudir a todas las visitas del estudio durante los 24 meses de duración del estudio.
    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.
    Los pacientes no serán aptos para el ensayo si no pueden asistir a todas las visitas requeridas del ensayo o si alguno de los siguientes criterios está presente sistémicamente o en el OE:
    Criterios de exclusión oftalmológicos
    Los siguientes criterios de exclusión se aplican al OE:
    -Indicios de neovascularización coroidea (NVC) en cualquier ojo.
    -Cualquier tratamiento previo para la DMAE (seca o húmeda) o cualquier tratamiento intravítreo previo para cualquier indicación en cualquiera de los ojos, excepto complementos orales de vitaminas y minerales.
    -Cualquier afección ocular en el OE que progrese durante el transcurso del estudio que podría afectar a la visión central o suponer un factor de confusión.
    -Presencia de otras causas de neovascularización coroidea
    -Cualquier intervención quirúrgica intraocular o procedimiento con láser térmico en los 3 meses previos a la inclusión en el estudio. Cualquier procedimiento previo con láser térmico en la región macular, con independencia de la indicación.
    -Cualquier infección ocular o periocular (incluida blefaritis) o inflamación de la superficie ocular en las 12 semanas anteriores.
    -Cualquier signo de retinopatía diabética en cualquier ojo.
    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)
    Criterio principal de valoración de la eficacia:
    -Tasa media de cambio en la atrofia geográfica durante 12 meses medida por autofluorescencia del fondo de ojo (FAF) en tres momentos: Inicio, mes 6 y mes 12 (transformación cuadrática)


    Criterios de valoración de la seguridad:
    -Acontecimientos adversos (AA)
    -Constantes vitales (pulso, tensión arterial sistólica y diastólica)
    -Hallazgos oftalmológicos (mejor agudeza visual corregida [MAVC], MAVC con baja luminosidad, presión intraocular [PIO] y exploración oftalmológica)
    -Electrocardiograma (ECG) (12 derivaciones)
    -Variables analíticas (sangre: hemograma, función renal, función hepática y electrolitos; análisis de orina)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Month 6, and Month 12
    Visita basal. mes 6 y mes 12
    E.5.2Secondary end point(s)
    not applicable
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    No aplica
    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 y simulación administrada por un investigador desenmascarado
    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 No
    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
    Ultima visita del ultimo sujeto
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 state33
    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
    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 Decision2020-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-30
    P. End of Trial
    P.End of Trial StatusCompleted
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