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    Summary
    EudraCT Number:2019-004132-37
    Sponsor's Protocol Code Number:SCD411-CP101
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-21
    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 number2019-004132-37
    A.3Full title of the trial
    A Phase III Randomized, Double-Masked, Parallel Group, Multicenter Study to Compare the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity between SCD411 and Eylea® in Subjects with Neovascular Age-related Macular Degeneration
    Studio multicentrico di Fase III, randomizzato, a doppio mascheramento, a gruppi paralleli, per confrontare l'efficacia, la sicurezza, la tollerabilità, la farmacocinetica e l'immunogenicità tra SCD411 ed Eylea® in soggetti affetti da degenerazione maculare neovascolare correlata all'età.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to determine if a potential new drug (SCD411) is similar to the marketed product Eylea® in the efficacy, is safe and similar tolerable and distributed, by testing its effect on the body in patients with Neovascular Age-related Macular Degeneration
    Uno studio clinico per determinare se un potenziale nuovo farmaco (SCD411) è simile al prodotto commercializzato Eylea® nell'efficacia, è sicuro e ugualmente tollerabile e distribuito, testando il suo effetto sul corpo in pazienti con degenerazione maculare legata all'età neovascolare
    A.3.2Name or abbreviated title of the trial where available
    not available
    not available
    A.4.1Sponsor's protocol code numberSCD411-CP101
    A.5.4Other Identifiers
    Name:INDNumber:144376
    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 SponsorSam Chun Dang Pharm. Co. Ltd
    B.1.3.4CountryKorea, Republic of
    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 supportSamChunDang Pharm. Co. Ltd.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSamChunDang Pharm. Co. Ltd
    B.5.2Functional name of contact pointClinical Development
    B.5.3 Address:
    B.5.3.1Street Address351, Hyoryeong-ro, Seocho-gu
    B.5.3.2Town/ citySeoul
    B.5.3.3Post code06643
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number+82318886367
    B.5.5Fax number+82318886366
    B.5.6E-mailSCD411clinial@scd.co.kr
    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 nameSCD411
    D.3.2Product code [SCD411]
    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 codeSCD411
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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
    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 nameEylea
    D.3.2Product code [Eylea]
    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 code-
    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 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
    Neovascular Age-related Macular Degeneration
    Degenerazione maculare neovascolare correlata all'età
    E.1.1.1Medical condition in easily understood language
    Age-related macular degeneration (AMD) is a disease that impacts the central area of the retina in the eye, called the macula. AMD is a leading cause of blindness
    La degenerazione maculare correlata all'età (AMD) è una malattia che colpisce l'area centrale della retina nell'occhio, chiamata macula. AMD è una delle principali cause di cecità
    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 prove the equivalence of SCD411 as compared to Eylea (aflibercept) in best corrected visual acuity (BCVA) after 8 weeks of treatment among subjects with wet AMD
    Dimostrare l'equivalenza di SCD411 rispetto a Eylea (aflibercept) nella migliore acuità visiva corretta (BCVA) dopo 8 settimane di trattamento tra soggetti affetti da AMD umida.
    E.2.2Secondary objectives of the trial
    • To compare the safety and tolerability of SCD411 and aflibercept
    • To compare the efficacy of SCD411 and aflibercept after 8 weeks and 52 weeks of treatment demonstrated by BCVA, central retinal thickness (CRT), and CNV
    • To compare the immunogenicity of SCD411 and aflibercept by presenting information of the development of anti-SCD411 antibodies
    • Mettere a confronto la sicurezza e la tollerabilità di SCD411 e aflibercept
    • Mettere a confronto l'efficacia di SCD411 e aflibercept dopo 8 settimane e dopo 52 settimane di trattamento dimostrata da BCVA, spessore retinico centrale (CRT) e neovascolarizzazione coroideale (CNV)
    • Mettere a confronto l'immunogenicità di SCD411 e aflibercept presentando informazioni sullo sviluppo di anticorpi anti-SCD411.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements.
    2. Age greater than or equal to 50 years.
    3. Active choroidal neovascularization lesions secondary to AMD evidenced by fluorescein angiography (FA) in the study eye at screening and confirmed by the central reading center.
    4. The BCVA letter score of 73 to 35 using original series ETDRS charts or 2702 series number charts in the study eye at screening and at Week 0 (Day 1) prior to randomization. In addition, fellow eye should not be less than 35 letter score using the ETDRS chart or 2702 series number chart
    5. Women of child-bearing potential with a negative serum pregnancy test at screening must agree to use protocol-defined methods of contraception throughout the study until 3 months after the last
    injection of aflibercept/SCD411 (Section 4.1.3 and Section 4.1.4).
    6. Males with female partners of child-bearing potential must agree to use protocol-defined methods of contraception and agree to refrain from donating sperm throughout the study until 3 months after the last injection of aflibercept/SCD411.
    1. Il soggetto è in grado di comprendere il consenso informato scritto, fornisce il consenso informato scritto firmato e alla presenza di un testimone e si impegna a rispettare i requisiti del protocollo
    2. Età maggiore o uguale 50 anni
    3. Lesioni attive di neovascolarizzazione coroideale secondarie ad AMD dimostrate dall'angiografia con fluoresceina (FA) nell'occhio oggetto di studio allo screening e confermate dal laboratorio di lettura centralizzata.
    4. Punteggio BCVA compreso tra 73 e 35 lettere utilizzando la serie originale di tavole dello studio sul trattamento precoce della retinopatia diabetica (ETDRS) o le tavole di serie numeriche 2702 nell'occhio oggetto di studio allo screening e alla Settimana 0 (Giorno 1) prima della randomizzazione. Inoltre, il punteggio dell’altro occhio non dovrebbe essere inferiore a 35 lettere utilizzando la tavola ETDRS o la tavola di serie numeriche 2702.
    5. Le donne in età fertile con un test di gravidanza sul siero negativo allo screening devono accettare di usare metodi contraccettivi definiti dal protocollo per tutta la durata dello studio fino a 3 mesi dopo l'ultima iniezione di aflibercept/SCD411.
    6. Gli uomini con partner di sesso femminile in età fertile devono accettare di utilizzare metodi di contraccezione definiti dal protocollo e accettare di astenersi dal donare sperma durante tutto lo studio fino a 3 mesi dopo l'ultima iniezione di aflibercept/SCD411.
    E.4Principal exclusion criteria
    1. Any prior ocular (in the study eye and fellow eye) or systemic treatment or surgery for neovascular AMD except dietary supplements or vitamins
    2. Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins
    3. Fellow eye shows signs of AMD that, in investigator's medical opinion, may need any treatment during study period
    4. Any prior treatment with anti-VEGF agents in the both eyes
    5. Total lesion size >30.5 mm2, including blood, scars, atrophy, fibrosis, and neovascularization as assessed by FA in the study eye and confirmed by the central reading center
    6. Central retina thickness of <300 µm in the study eye and confirmed by the central reading center
    7. Subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye and confirmed by the central reading center.
    8. Scar or fibrosis, making up >50% of the total lesion in the study eye and confirmed by the central reading center
    9. Scar, fibrosis, or atrophy involving the center of the fovea in the study eye and confirmed by the central reading center
    10. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye and confirmed by the central reading center
    11. Lens Opacity Classification System II grade IV cataract in the study eye, or other significant cataract in the study eye that in the Investigator's opinion interferes with visualization of retina or interferes
    with retinal imaging
    12. Active intraocular/periocular infection and inflammation in either eye
    13. History of any vitreous hemorrhage in the study eye within 4 wks prior to the Screening Visit
    14. Presence of other causes of CNV in the study eye as confirmed by central reading center
    15. History or clinical evidence of diabetic retinopathy, DME, or any other vascular disease affecting the retina, other than AMD, in either eye
    16. Prior vitrectomy in the study eye
    17. History of retinal detachment, treatment, or surgery for retinal detachment in the study eye
    18. History of macular hole of Stage 2 and above in the study eye as confirmed by central reading center
    19. History of uncomplicated intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of Day 1
    20. Presence of aphakia in the study eye

    Please, refer to study protocol V1.3_24Jul2020 for the complete exclusion criteria list
    1. Eventuale precedente trattamento oculare (nell'occhio oggetto di studio e nell'altro occhio) o trattamento sistemico o intervento chirurgico per AMD neovascolare ad eccezione di integratori alimentari o vitamine.
    2. Eventuale terapia precedente o concomitante con un altro agente sperimentale per il trattamento di AMD neovascolare nell'occhio oggetto di studio, ad eccezione di integratori alimentari o vitamine.
    3. L'altro occhio mostra segni di AMD che, secondo il giudizio clinico dello sperimentatore, potrebbero necessitare di trattamento durante il periodo dello studio
    4. Eventuale trattamento precedente con agenti anti-fattore di crescita vascolare endoteliale (VEGF) in entrambi gli occhi (ossia devono essere inclusi solamente soggetti completamente naïve al trattamento)
    5. Dimensione totale della lesione >30,5 mm2, inclusi sangue, cicatrici, atrofia, fibrosi e neovascolarizzazione, valutata in base a FA nell'occhio oggetto di studio e confermata dal centro di lettura centralizzata
    6. Spessore retinico centrale di <300 µm nell'occhio oggetto di studio e confermato dal centro di lettura centralizzata
    7. Emorragia sottoretinica pari al 50% o più dell'area totale della lesione, o se è presente sangue sotto la fovea e ha una dimensione di 1 o più aree del disco nell'occhio oggetto di studio, confermato dal centro di lettura centralizzata. (Se c’è sangue sotto la fovea, allora la fovea deve essere circondata a 270 gradi da CNV visibile)
    8. Cicatrice o fibrosi, che costituisce >50% della lesione totale nell'occhio oggetto di studio ed è confermata dal centro di lettura centralizzata
    9. Cicatrice, fibrosi o atrofia che coinvolge il centro della fovea nell'occhio oggetto di studio ed è confermata dal centro di lettura centralizzata
    10. Presenza di lacerazioni o strappi dell’epitelio pigmentato retinico che coinvolgono la macula nell'occhio oggetto di studio e sono confermati dal centro di lettura centralizzata
    11. Cataratta di grado IV nell'occhio oggetto di studio secondo il Sistema di classificazione delle opacità del cristallino (LOCS II). - o altre cataratte significative nell'occhio oggetto di studio che secondo l’opinione dello Sperimentatore interferiscono con la visualizzazione della retina o interferiscono con l'imaging retinico.
    12. Infezione e infiammazione attiva intraoculare/perioculare in uno dei due occhi.
    13. Anamnesi di eventuale emorragia vitreale nell'occhio oggetto di studio entro le 4 settimane precedenti la Visita di screening.
    14. Presenza di altre cause di CNV nell'occhio oggetto di studio, come confermato dal centro di lettura centralizzata.
    15. Anamnesi o evidenza clinica di retinopatia diabetica, edema maculare diabetico o qualsiasi altra malattia vascolare che colpisca la retina, diversa dall'AMD, in uno dei due occhi.
    16. Precedente vitrectomia nell'occhio oggetto di studio.
    17. Anamnesi di distacco della retina, trattamento o intervento chirurgico per il distacco della retina nell'occhio oggetto di studio
    18. Anamnesi di foro maculare di Stadio 2 e superiore nell'occhio oggetto di studio, come confermato dal centro di lettura centralizzata.
    19. Anamnesi di intervento chirurgico intraoculare o perioculare non complicato entro 3 mesi dal Giorno 1 sull’occhio oggetto di studio, ad eccezione della chirurgia palpebrale, che può non essere stata eseguita entro 1 mese dal Giorno 1 dello studio
    Nota: Un soggetto con capsulotomia laser al granato di ittrio e alluminio drogato al neodimio (Nd:YAG) non complicata, eseguita per l'opacizzazione secondaria della capsula posteriore in occhio con impianto intraoculare di cristallino, entro 3 mesi prima del Giorno 1 nell'occhio oggetto di studio, sarà considerato eleggibile.
    20. Presenza di afachia nell'occhio oggetto di studio.

    Per la lista completa dei criteri di esclusione si prega di far riferimento al protocollo V1.3_24Jul2020
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    • Change from baseline in BCVA as measured by ETDRS letters score or 2702 charts.
    Endpoint primario:
    • Variazione rispetto alla baseline della BCVA misurata in base al punteggio per le lettere delle tavole ETDRS o 2702 alla Settimana 8.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at week 8
    alla settimana 8
    E.5.2Secondary end point(s)
    Secondary endpoints:
    • Change from baseline in best corrected visual acuity (BCVA) as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score or 2702 charts at Week 52
    • Change from baseline in CRT at Week 8 as assessed by optical coherence tomography (OCT)
    • Change from baseline in central retinal thickness (CRT) at Week 52 as assessed by OCT
    • Change from baseline in choroidal neovascularization (CNV) area at Week 8
    • Change from baseline in CNV area at Week 52
    • Percentage of subjects who gain at least 15 letters in BCVA as measured by ETDRS letter score or 2702 charts compared with baseline at Week 8
    • Percentage of subjects who gain at least 15 letters in BCVA as measured by ETDRS letter score or 2702 charts compared with baseline at Week 52.
    Endpoint secondari:
    • Variazione rispetto alla baseline della BCVA, misurata in base al punteggio per le lettere delle tavole ETDRS o 2702 alla settimana 52
    • Variazione rispetto alla baseline del CRT alla Settimana 8 valutata mediante tomografia ottica computerizzata (OCT)
    • Variazione rispetto alla baseline del CRT alla Settimana 52 valutata mediante OCT
    • Variazione rispetto alla baseline dell’area di CNV alla Settimana 8
    • Variazione rispetto alla baseline dell’area di CNV alla Settimana 52
    • Percentuale di soggetti che migliorano di almeno 15 lettere nella BCVA misurata in base al punteggio per le lettere delle tavole ETDRS o 2702 rispetto alla baseline alla Settimana 8
    • Percentuale di soggetti che migliorano di almeno 15 lettere nella BCVA misurata in base al punteggio per le lettere delle tavole ETDRS o 2702 rispetto alla baseline alla Settimana 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at week 8, at week 52
    alle settimane 8 e 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Inmunogenicity
    Immunogenicità
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    Australia
    India
    Israel
    Japan
    Korea, Republic of
    Russian Federation
    United States
    Bulgaria
    Czechia
    Hungary
    Italy
    Latvia
    Poland
    Slovakia
    Spain
    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 months10
    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 months8
    E.8.9.2In all countries concerned by the trial days24
    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: 168
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 392
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 232
    F.4.2.2In the whole clinical trial 560
    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)
    Treatment of Neovascular Age-related Macular Degeneration in both eyes as per PI's standard of care (SOC) and his/her discretion
    Trattamento della degenerazione maculare neovascolare correlata all'età in entrambi gli occhi secondo lo standard di cura e a discrezione del PI
    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 Decision2020-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-10
    P. End of Trial
    P.End of Trial StatusOngoing
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