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    Summary
    EudraCT Number:2018-002152-32
    Sponsor's Protocol Code Number:GR40306
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-03-25
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2018-002152-32
    A.3Full title of the trial
    A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, ACTIVE COMPARATOR-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FARICIMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (TENAYA)
    III-AS FÁZISÚ, MULTICENTRIKUS, RANDOMIZÁLT, KETTŐSEN ÁLCÁZOTT, AKTÍV KOMPARÁTORRAL KONTROLLÁLT VIZSGÁLAT A FARICIMAB HATÁSOSSÁGÁNAK ÉS BIZTONSÁGOSSÁGÁNAK ÉRTÉKELÉSÉRE NEOVASZKULÁRIS IDŐSKORI MAKULADEGENERÁCIÓBAN SZENVEDŐ BETEGEKNÉL (TENAYA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Faricimab in Patients with Neovascular Age-Related Macular Degeneration (Tenaya)
    A.3.2Name or abbreviated title of the trial where available
    TENAYA
    A.4.1Sponsor's protocol code numberGR40306
    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 SponsorF.Hoffmann La-Roche Ltd
    B.1.3.4CountrySwitzerland
    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 supportF.Hoffmann La-Roche Ltd - Basel
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche LTD
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameFaricimab
    D.3.2Product code RO6867461/F06
    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 INNnot available
    D.3.9.1CAS number 1607793-29-2
    D.3.9.2Current sponsor codeRO6867461
    D.3.9.3Other descriptive nameVA2, VEGF-Ang2 ophtha Humanized anti-VEGF-A anti-Ang-2 bispecific Antibody
    D.3.9.4EV Substance CodeSUB126170
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 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.3.4Pharmaceutical 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 codeRo 717-1571
    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 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
    E.1.1.1Medical condition in easily understood language
    Neovascular Age-related macular degeneration (nAMD), also known as wet AMD, is a medical condition which may result in distortion and potentially irreversible loss of the central vision
    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 evaluate the efficacy of IVT (intravitreal) injections of faricimab on change in best-corrected visual acuity (BCVA)
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of faricimab on additional BCVA outcomes
    • To evaluate the frequency of study drug administration
    • To evaluate the efficacy of faricimab on anatomical outcome measures using optical coherence tomography (OCT) and fundus fluorescein angiography (FFA)
    • To evaluate the ocular and non-ocular safety and tolerability of faricimab
    • To characterize the systemic pharmacokinetics of faricimab
    • To evaluate the immune response to faricimab
    • To evaluate potential effects of anti-drug antibody (ADA)s
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >= 50 years
    - Ability to comply with the study protocol
    - For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 3 months after the final dose of study treatment
    - Treatment-naïve choroidal neovascularization (CNV) secondary to AMD (nAMD) in the study eye
    - BCVA of 20/32 to 20/320 (letter score of 78 to 24) in the study eye at the initiation of treatment
    E.4Principal exclusion criteria
    - Uncontrolled blood pressure
    - Pregnancy or breastfeeding, or intention to become pregnant during the study
    - CNV due to causes other than AMD in the study eye
    - Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye
    - Presence at screening of central serous chorioretinopathy in the study eye
    - Retinal pigment epithelial tear involving the macula on Day 1 in the study eye
    - On FFA/ Color fundus photograph:
    o Subretinal hemorrhage of > 50% of the total lesion area and/or that involves the fovea
    o Fibrosis or atrophy of > 50% of the total lesion area and/or that involves the fovea
    - Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study
    - Current vitreous hemorrhage on Day 1 in the study eye
    - Uncontrolled glaucoma in the study eye
    - Spherical equivalent of refractive error demonstrating more than 8 diopters of myopia in the study eye
    - Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye
    - Any cataract surgery or treatment for complications of cataract surgery with steroids or YAG laser capsulotomy in the study eye within 3 months prior to Day 1
    - Any other intraocular surgery in the study eye
    - Prior periocular pharmacological or IVT treatment for other retinal diseases in the study eye
    - Prior IVT administration of faricimab in either eye
    - Active ocular inflammation or suspected or active ocular or periocular infection in either eye
    E.5 End points
    E.5.1Primary end point(s)
    1. Change in BCVA from baseline to average at Weeks 40, 44 and 48


    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline (Day 1), Weeks 40, 44, and 48
    E.5.2Secondary end point(s)
    1. Change from baseline in BCVA over time
    2. Proportion of patients gaining >= 15, >= 10, >= 5, or >= 0 letters in BCVA from baseline over time
    3. Proportion of patients avoiding loss of >= 15, >= 10, >=5, or >= 0 letters in BCVA from baseline over time
    4. Proportion of patients with BCVA Snellen equivalent of 20/40 or better over time
    5. Proportion of patients gaining >= 15 letters or achieving BCVA of >= 84 letters over time
    6. Proportion of patients with BCVA Snellen equivalent of 20/200 or worse over time
    7. Proportion of patients on different treatment intervals at Weeks 48, 60, and 112
    8. Number of study drug injections received through Weeks 48, 60, and 112
    9. Change from baseline in CST based on an average at Weeks 40, 44, and 48
    10. Change from baseline in CST over time
    11. Proportion of patients with absence of intraretinal fluid over time
    12. Proportion of patients with absence of subretinal fluid over time
    13. Proportion of patients with absence of intraretinal and subretinal fluid over time
    14. Proportion of patients with absence of intraretinal cysts over time
    15. Proportion of patients with absence of pigment epithelium detachment over time
    16. Change from baseline in total area of CNV lesion at Week 48 and Week 112
    17. Change from baseline in total area of leakage at Week 48 and Week 112
    18. Incidence and severity of ocular adverse events
    19. Incidence and severity of non-ocular adverse events
    20. Plasma concentration of faricimab over time
    21. Presence of ADAs during the study relative to the presence of ADAs at baseline
    22. Relationship between ADA status and efficacy, safety, or pharmacokinetic endpoints
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-6. Baseline to Week 112
    7-8. Week 48, 60, and 112
    9-15. Baseline to Week 112
    16-17. Baseline, Week 48 and 112
    18-19. Up to Week 112
    20. Week 1, 4, 16, 20, 48, 76, 112
    21-22. Week 1, 4, 20, 48, 76, 112

    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 Yes
    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
    Immunogenicity
    Biomarker
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    Brazil
    Canada
    Germany
    Hungary
    Israel
    Italy
    Japan
    Mexico
    Netherlands
    Poland
    Russian Federation
    Spain
    Switzerland
    Turkey
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    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: 165
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 475
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 640
    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)
    A patient will be eligible to receive Roche IMP (faricimab) after completing the study if all of the following conditions are met:
    • The patient has a sight-threatening or severe medical condition and requires continued Roche IMP treatment for his or her well-being
    • There are no appropriate alternative treatments available to the patient
    • The patient and his or her doctor comply with and satisfy any legal or regulatory requirements that apply to them
    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 Decision2019-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-03
    P. End of Trial
    P.End of Trial StatusOngoing
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