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    Summary
    EudraCT Number:2022-000690-73
    Sponsor's Protocol Code Number:BAY86-5321/21912
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-07-28
    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 ConcernedFrance - ANSM
    A.2EudraCT number2022-000690-73
    A.3Full title of the trial
    A Parallel-group Phase 4, Open-label, Two-arm Study to Assess the Safety and Efficacy of Intravitreal (IVT) Aflibercept with Proactive customized Treatment Intervals in Patients ≥50 Years of Age with No Fluid Due to Choroidal Neovascularization (CNV) Lesions Secondary to Neovascular (wet) Age-related Macular Degeneration (nAMD) Following Treatment Initiation with Aflibercept
    Étude de phase 4, en ouvert, à deux groupes parallèles, évaluant la sécurité et l’efficacité d’un traitement intravitréen (IVT) par aflibercept à intervalles thérapeutiques personnalisés proactifs chez des patients âgés de ≥ 50 ans sans présence de liquide dû à une néovascularisation choroïdienne (NVC) secondaire à une dégénérescence maculaire liée à l’âge néovasculaire (humide) (DMLAn), après l’instauration d’un traitement par aflibercept
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to learn how well Aflibercept injected into the eye works and how safe it is when given in customized treatment intervals in patients with an eye disease called neovascular age-related macular degeneration after start of treatment
    Une étude pour savoir comment l’Aflibercept injecté dans l’œil fonctionne bien et à quel point il est sûr lorsqu’il est administré à des intervalles thérapeutiques personnalisés chez les patients atteints d’une maladie oculaire appelée dégénérescence maculaire liée à l’âge après le début du traitement
    A.3.2Name or abbreviated title of the trial where available
    XPAND
    A.4.1Sponsor's protocol code numberBAY86-5321/21912
    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 SponsorBayer AG
    B.1.3.4CountryGermany
    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 supportBayer AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressCTP Team/Ref:”EU CTR”/Bayer AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayer.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 Yes
    D.2.1.1.1Trade name Eylea 40mg/ml solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAflibercept
    D.3.2Product code BAY 86-5321
    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 INNAflibercept
    D.3.9.1CAS number 862111-32-8
    D.3.9.2Current sponsor codeBAY 86-5321
    D.3.9.3Other descriptive nameVEGF Trap-Eye
    D.3.9.4EV Substance CodeSUB26987
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    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
    Neovascular (wet) age-related macular degeneration
    Dégénérescence maculaire liée à l’âge néovasculaire (humide)
    E.1.1.1Medical condition in easily understood language
    An eye disorder caused by abnormal blood vessels that leak fluid into the central part of the retina at the back of the eye leading to blurring or a blind spot in the central (straight ahead) vision
    Trouble oculaire du à des vaisseaux sanguins anormaux laissant échapper du liquide dans la partie centrale de la rétine à l’arrière de l’œil entraînant un flou ou un angle mort dans la vision centrale
    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 10071129
    E.1.2Term Neovascular 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
    To assess whether 2 mg intravitreal (IVT) aflibercept administered at a customized treatment interval (determined after the first extended treatment interval) is non-inferior to 2 mg IVT aflibercept administered according to a standard treat and extend (T&E) regimen (initiated after the first extended treatment interval) in patients with no fluid following treatment initiation for neovascular (wet) age-related macular degeneration (nAMD)
    Évaluer si un traitement intravitréen (IVT) par aflibercept 2 mg administré à un intervalle thérapeutique personnalisé (déterminé après le premier intervalle prolongé) est non inférieur à un traitement IVT par aflibercept 2 mg administré selon une approche standard « traitement et extension » (T&E) (débutant après le premier intervalle thérapeutique prolongé) chez des patients sans présence de liquide après l’instauration d’un traitement pour une dégénérescence maculaire liée à l’âge néovasculaire (humide) (DMLAn)
    E.2.2Secondary objectives of the trial
    1. To assess treatment burden of 2 mg IVT aflibercept administered at a customized treatment interval compared with 2 mg IVT aflibercept administered according to a standard T&E regimen (initiated after the first extended treatment interval) in patients with no fluid following treatment initiation for nAMD
    2. To evaluate the safety of aflibercept with proactive treatment intervals
    1. Évaluer la charge thérapeutique de l’administration IVT d’aflibercept 2 mg à un intervalle thérapeutique personnalisé par rapport à l’administration IVT d’aflibercept 2 mg selon une approche standard T&E (débutant après le premier intervalle thérapeutique prolongé) chez des patients sans présence de liquide après l’instauration d’un traitement pour une DMLAn
    2. Évaluer la sécurité de l’aflibercept à des intervalles thérapeutiques proactifs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent and able to read (or if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member), understand, and willing to sign the ICF.
    2. Men and women ≥50 years of age.
    3. At treatment initiation, active macular neovascular lesions secondary to nAMD (Patients with polypoidal choroidal vasculopathy or retinal angiomatous proliferation are eligible to participate in the study, and their condition should be captured in the electronic case report form [eCRF]).
    4. Treatment initiation with 3 × monthly IVT aflibercept injections (Weeks -16, -12, and -8 to planned study baseline visit) resulting in absence of any fluid at week -8.
    5. ETDRS BCVA of at least 25 letters (20/320 Snellen equivalent) in the study eye at screening visit.
    6. Willing, committed, and able to return for all clinic visits and complete all study-related procedures.
    7. Able to use the provided monitoring device and willing to perform 5 × weekly self-assessments in the Investigator’s opinion.
    8. Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the ICF and 3 months after the last administration of study drug.
    1. Consentement éclairé écrit et capacité à lire (ou si incapacité à lire en raison d’une déficience visuelle, lecture mot à mot par la personne qui administre le consentement éclairé ou un membre de la famille), comprendre et volonté de signer le FCE.
    2. Hommes et femmes âgés de ≥ 50 ans.
    3. Lors de l’instauration du traitement, présence de lésions néovasculaires maculaires actives secondaires à une DMLAn (les patients ayant une vasculopathie polypoïdale choroïdienne ou une prolifération angiomateuse rétinienne sont éligibles pour participer à l’étude, et leur pathologie doit être consignée dans le cahier d’observation électronique [eCRF]).
    4. Instauration du traitement par 3 × injections IVT mensuelles d’aflibercept (Semaines -16, -12 et -8 par rapport à la visite programmée d’inclusion dans l’étude) aboutissant à une absence de liquide à la Semaine -8.
    5. MAVC d’au moins 25 lettres ETDRS (équivalent 20/320 Snellen) dans l’œil à l’étude à la visite de sélection.
    6. Volonté, engagement et capacité à se rendre à toutes les visites cliniques et à effectuer toutes les procédures liées à l’étude.
    7. Selon l’opinion de l’investigateur, capacité, à utiliser le dispositif de surveillance fourni et volonté d’effectuer 5 × auto-évaluations hebdomadaires.
    8. Les hommes et femmes aptes à procréer devront accepter d’utiliser des moyens de contraception appropriés lors des rapports sexuels. Cela s’applique à la période entre la signature du FCE et 3 mois après la dernière administration du médicament à l’étude.
    E.4Principal exclusion criteria
    1. Any contraindication to IVT anti-VEGF treatment or treatment with Eylea® as detailed in the Summary of Product Characteristics (SmPC).
    2. Any prior ocular (in the study eye) or systemic treatment (including investigational agents) or surgery for nAMD, except the 3 × monthly IVT aflibercept injections required for treatment initiation and dietary supplements or vitamins.
    3. Any presence of intraretinal and subretinal fluid.
    4. Any ocular or systemic condition expected to interfere with study outcomes and procedures, including but not limited to:
    • Scar, fibrosis or other lesions (e.g., retinal pigment epithelium [RPE] tears, macular hole stage 2 or above and others) involving the center of the macula in the study eye.
    • Clinically relevant opacities or conditions involving the optic media including cataract, corneal dystrophies or s.p. corneal transplant in the study eye.
    • Uncontrolled glaucoma (defined as IOP ≥25 mm Hg despite treatment with antiglaucoma medication) in the study eye or prior trabeculectomy or other filtration surgery in the study eye.
    • Intraocular surgery, periocular surgery, or cataract surgery within 90 days before Day 1 in the study eye, except the IVT aflibercept injections required for treatment initiation and any history of vitrectomy, retinal radiation therapy, retinal detachment or treatment or surgery for retinal detachment in the study eye.
    • Aphakia or pseudophakia with absence of posterior capsule (unless as a result of an yttrium aluminum garnet posterior capsulotomy) in the study eye.
    5. Participation as a patient in any clinical study within 12 weeks before screening.
    6. Close affiliation with the investigational site; e.g., a close relative of the Investigator, dependent person (e.g., employee or student of the investigational site).
    7. Previously screen failed patients for this study
    1. Toute contre-indication au traitement IVT par anti-VEGF ou au traitement par Eylea®conformément à ce qui est détaillé dans le résumé des caractéristiques du produit (RCP).
    2. Tout antécédent de traitement oculaire (dans l’œil à l’étude) ou systémique (y compris par des agents expérimentaux) ou chirurgie pour DMLAn, sauf les 3 × injections IVT mensuelles d’aflibercept exigées pour l’instauration du traitement et les compléments nutritionnels ou les vitamines.
    3. Toute présence de liquide intrarétinien et sous-rétinien à la sélection et à la visite d’inclusion.
    4. Toute pathologie oculaire ou systémique susceptible d’interférer avec les résultats et procédures de l’étude, y compris notamment :
    • Cicatrice, fibrose ou autres lésions (par exemple, déchirures de l’épithélium pigmentaire rétinien [EPR], trou maculaire de stade 2 ou supérieur et autres) impliquant le centre de la macula de l’œil à l’étude.
    • Opacités cliniquement significatives ou pathologies impliquant les milieux optiques, y compris cataracte, dystrophies cornéennes ou greffe cornéenne dans l’œil à l’étude.
    • Glaucome non contrôlé (défini comme une PIO ≥25 mm Hg malgré un traitement médicamenteux contre le glaucome) dans l’œil à l’étude ou antécédents de trabéculectomie ou autre chirurgie de filtration dans l’œil à l’étude.
    • Chirurgie intraoculaire, périoculaire ou de la cataracte dans les 90 jours avant le Jour 1 dans l’œil à l’étude, hormis les injections IVT d’aflibercept exigées pour l’instauration du traitement et tout antécédent de vitrectomie, radiothérapie rétinienne, décollement de la rétine ou traitement ou chirurgie d’un décollement de la rétine dans l’œil à l’étude.
    • Aphakie ou pseudophakie avec absence de capsule postérieure (sauf si résultant d’une capsulotomie postérieure au laser YAG [yttrium-aluminium-garnet]), dans l’œil à l’étude.
    5. Participation en tant que patient à une étude clinique dans les 12 semaines avant la sélection.
    6. Affiliation étroite avec le centre d’étude, par exemple, proche parent de l’investigateur, personne dépendante (par exemple, employé ou étudiant dans le centre d’étude).
    7. Antécédents d’échec de sélection dans la présente étude.
    E.5 End points
    E.5.1Primary end point(s)
    Change in best-corrected visual acuity (BCVA) (early treatment diabetic retinopathy study [ETDRS] letters)
    Modification de la meilleure acuité visuelle corrigée (MAVC) (étude sur le traitement précoce de la rétinopathie diabétique [ETDRS] (Early Treatment Diabetic Retinopathy Study)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Week 36
    à la semaine 36 par rapport à l’inclusion
    E.5.2Secondary end point(s)
    1. Number of IVT aflibercept injections per patient
    2. Number of IVT aflibercept injections per patient
    3. Number of patients achieving pre-defined treatment intervals (≥4, ≥8, ≥10, ≥12¸ ≥14, and 16 weeks)
    4. Change in BCVA (ETDRS letters)
    5. Number of subjects with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
    1. Nombre d’injections IVT d’aflibercept par patient
    2. Nombre d’injections IVT d’aflibercept par patient
    3. Nombre de patients parvenant à des intervalles thérapeutiques prédéfinis (≥ 4, ≥ 8, ≥ 10, ≥ 12¸ ≥ 14 et 16 semaines)
    4. Modification de la MAVC (lettres ETDRS)
    5. Événements indésirables apparaissant sous traitement (EIAT) et événements indésirables graves apparaissant sous traitement (EIGAT)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From baseline up to Week 52
    2. From baseline up to Week 36
    3. At Weeks 36 and 52
    4. From baseline up to Week 52
    5. From baseline up to Week 36 and Week 52
    1. de l'inclusion jusqu'à la semaine 52
    2. de l'inclusion jusqu'à la semaine 36
    3. aux semaines 36 et 52
    4. de l'inclusion jusqu'à la semaine 52
    5. de l'inclusion jusqu'à la semaine 36 et la semaine 52

    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    Standard treat and extend regimen-2 week-adjustment
    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 concerned6
    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 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
    Canada
    France
    Spain
    Germany
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    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 subject last visit
    dernière visite du dernier patient
    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 months1
    E.8.9.1In the Member State concerned days11
    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 days11
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 103
    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 No
    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 65
    F.4.2.2In the whole clinical trial 108
    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 Decision2022-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-06-21
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