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    Summary
    EudraCT Number:2022-002860-59
    Sponsor's Protocol Code Number:ISEE2009
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-10-07
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2022-002860-59
    A.3Full title of the trial
    An Open-label Extension (OLE) Phase 3 Trial to Assess the Safety of Intravitreal Administration of avacincaptad pegol (Complement C5 Inhibitor) in Patients with Geographic Atrophy Who Previously Completed Phase 3 Study ISEE2008 (GATHER2)
    Estudio de extensión abierta (OLE) de fase III para evaluar la seguridad de la administración intravítrea de avacincaptad pegol (inhibidor del complemento C5) en pacientes con atrofia geográfica que han completado previamente el estudio de fase III ISEE2008 (GATHER2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-Label Extension Study for Patients who Previously Completed Study ISEE2008 (GATHER2).
    Un estudio de extensió abierto para pacientes que completaron previamente el estudio ISEE2008 (GATHER2).
    A.3.2Name or abbreviated title of the trial where available
    GATHER2 OLE
    GATHER2 OLE
    A.4.1Sponsor's protocol code numberISEE2009
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05536297
    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 Clinical Development
    B.5.3 Address:
    B.5.3.1Street Address1249 South River Road, Suite 107
    B.5.3.2Town/ cityCranbury
    B.5.3.3Post codeNJ 08512
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1917-692-1788
    B.5.6E-mailjulie.clark@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 nameavacincaptad pegol
    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
    Atrofia geográfica
    E.1.1.1Medical condition in easily understood language
    geographic atrophy
    Atrofia greográfica
    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 10063947
    E.1.2Term Geographic atrophy
    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
    The objectives of this trial are to assess long-term safety of avacincaptad pegol monthly intravitreal administration for patients with GA who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham).
    Los objetivos de este estudio son evaluar la seguridad a largo plazo de la administración intravítrea de avacincaptad pegol en pacientes con atrofia geográfica (AG) que completaron el estudio ISEE2008 (GATHER2) y continuaron con el tratamiento del estudio (avacincaptad pegol o el tratamiento simulado) hasta la visita del mes 24.
    E.2.2Secondary objectives of the trial
    n/a
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female patients aged 50 years or greater diagnosed with GA inside and/or outside of the fovea who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment, regardless of whether they received treatment with avacincaptad pegol or Sham previously, refer to Section 8.2 of the ISEE2008 protocol for inclusion criteria details. Patients must provide new written informed consent for this OLE trial prior to participating and have the ability to return for all trial visits for the duration of the 18-month trial.
    Pacientes masculinos o femeninos de 50 años o más diagnosticados con AG dentro y/o fuera de la fóvea que completaron el estudio ISEE2008 (GATHER2) hasta la visita del Mes 24 en el tratamiento del estudio, independientemente de si recibieron tratamiento con avacincaptad pegol o Sham anteriormente, derivar a la Sección 8.2 del protocolo ISEE2008 para conocer los detalles de los criterios de inclusión. Los pacientes deben proporcionar un nuevo consentimiento informado por escrito para este ensayo OLE antes de participar y tener la posibilidad de regresar para todas las visitas del ensayo durante los 18 meses del ensayo.
    E.4Principal exclusion criteria
    Patients will not be eligible for the trial if:
    1. Patient did not complete Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham),
    2. Any patients who had the study drug permanently withdrawn for an AE are not eligible; patients who had study drug temporarily withheld for an AE(s) or elective ocular surgery will be reviewed on case by case basis for eligibility,
    3. Patient did not enroll into this OLE trial within the 90 days enrollment period.
    4. Patients who are pregnant or nursing
    Los pacientes no serán elegibles para el estudio si:
    1. El paciente no completó el estudio ISEE2008 (GATHER2) hasta la visita del mes 24 de tratamiento del estudio (ya sea avacincaptad pegol o Sham),
    2. Los pacientes a los que se les retiró el fármaco del estudio de forma permanente por un EA no son elegibles; los pacientes a los que se les retuvo temporalmente el fármaco del estudio debido a un AA o cirugía ocular electiva serán revisados caso por caso para determinar su elegibilidad,
    3. El paciente no se inscribió en este ensayo OLE dentro del período de inscripción de 90 días.
    4. Pacientes embarazadas o lactantes.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Endpoints:
    • AEs
    • Ophthalmic variables
    o best corrected visual acuity (BCVA)
    o low luminance visual acuity (LL VA)
    o intraocular pressure (IOP)
    o ophthalmic examination
    • Immunogenicity and Pharmacokinetics
    Puntos finales de seguridad:
    • EA
    • Variables oftálmicas
    o mejor agudeza visual corregida (MAVC)
    o agudeza visual de baja luminancia (LL VA)
    o presión intraocular (PIO)
    examen oftalmológico
    • Inmunogenicidad y Farmacocinética
    E.5.1.1Timepoint(s) of evaluation of this end point
    n/a
    No aplica
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 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 concerned7
    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
    Israel
    Austria
    France
    Latvia
    Poland
    Spain
    Czechia
    Germany
    Italy
    Belgium
    Croatia
    Hungary
    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
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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 state28
    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
    Niguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-25
    P. End of Trial
    P.End of Trial StatusOngoing
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