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    Summary
    EudraCT Number:2017-005104-10
    Sponsor's Protocol Code Number:GR40349
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-10-02
    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 ConcernedAustria - BASG
    A.2EudraCT number2017-005104-10
    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 (RO6867461) IN PATIENTS WITH DIABETIC MACULAR EDEMA (YOSEMITE)
    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 Diabetic Macular Edema (YOSEMITE)
    A.3.2Name or abbreviated title of the trial where available
    YOSEMITE
    A.4.1Sponsor's protocol code numberGR40349
    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
    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 INNFaricimab
    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
    Diabetic Macular Edema (DME)
    E.1.1.1Medical condition in easily understood language
    Diabetic macular edema (DME)
    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 10057934
    E.1.2Term Diabetic macular edema
    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
    •To evaluate the efficacy of intravitreal (IVT) injections of Faricimab on best-corrected visual acuity (BCVA) outcomes
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of Faricimab on diabetic retinopathy (DR) severity outcomes
    •To evaluate the efficacy of Faricimab on additional BCVA outcomes
    •To evaluate the efficacy of Faricimab on additional DR outcomes
    •To evaluate Faricimab treatment intervals as specified in the protocol
    •To evaluate the efficacy of Fricimab on anatomical outcome measures using spectral-domain optical coherence tomography (SD OCT)
    •To evaluate the efficacy of Faricimab on patient-reported visionrelated functioning and quality of life using the National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25)
    •To evaluate the ocular and systemic 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 antibodies (ADAs)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >= 18 years
    - Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
    - Ability and willingness to undertake all scheduled visits and assessments
    - 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
    - Macular thickening secondary to DME involving the center of the fovea
    - Documented BCVA of 20/40 to 20/320 (letter score of 73 to 25) in the study eye at the initiation of treatment
    E.4Principal exclusion criteria
    - Currently untreated diabetes mellitus or previously untreated patients who initiated oral anti-diabetic medication or insulin within 3 months prior to Day 1
    - Uncontrolled blood pressure
    - Pregnancy or breastfeeding, or intention to become pregnant during the study

    Ocular Exclusion Criteria for Study Eye
    - Treatment with panretinal photocoagulation within 3 months prior to Day 1 to the study eye
    - Macular laser within 3 months prior to Day 1 to the study eye
    - Any IVT or periocular corticosteroid treatment within 6 months prior to Day 1 to the study eye
    - Any use of medicated intraocular implants, including Ozurdex®, within 6 months of Day 1 and Iluvien® implants at any time prior to Day 1 to the study eye
    - Prior administration of IVT RO6867461 in either eye
    - Active intraocular or periocular infection or active intraocular inflammation in the study eye
    - Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
    - Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
    E.5 End points
    E.5.1Primary end point(s)
    1. Change from baseline in BCVA at 1 year


    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline (Day 1) and 1 year
    E.5.2Secondary end point(s)
    1. Proportion of patients with a >= 2-step DRS improvement from baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at 1 year
    2. Change from baseline in BCVA over time
    3. Proportion of patients gaining >=15, >=10, >= 5, or >= 0 letters in BCVA from baseline over time
    4. Proportion of patients avoiding a loss of >= 15, >= 10, >= 5, or > 0 letters in BCVA from baseline over time
    5. Proportion of patients with a >= 2-step DRS improvement from baseline on the ETDRS DRSS over time
    6. Proportion of patients with a >= 3-step DRS improvement from baseline on the ETDRS DRSS over time
    7. Proportion of patients gaining >=15 letters or achieving BCVA of >= 84 letters over time
    8. Proportion of patients with BCVA Snellen equivalent of 20/40 or better over time
    9. Proportion of patients with BCVA Snellen equivalent of 20/200 or worse over time
    10. Proportion of patients who develop new PDR over time
    11. Proportion of patients in the personalized treatment interval (PTI) arm on every 4, 8, 12 weeks or 16 weeks treatment interval at 1 year and 2 years
    12. Treatment intervals in the PTI arm over time
    13. Change from baseline in central subfield thickness (CST) over time
    14. Change from baseline in NEI VFQ-25 composite score over time
    15. Proportion of patients with absence of DME over time
    16. Incidence and severity of ocular adverse events
    17. Incidence and severity of non-ocular adverse events
    18. Plasma concentration of Faricimab over time
    19. Presence of ADAs during the study relative to the presence of ADAs at baseline
    20. Relationship between ADA status and efficacy, safety, or PK endpoints
    21. Change from baseline in CST at 1 year
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At 1 year
    2-6. Baseline to 2 years
    7-10. Up to 2 years
    11. At 1 and 2 years
    12. Up to 2 years
    13-14. Baseline to 2 year
    15-18. Up to 2 years
    19-20. Day 1, Week 4; Week 28; Week 52; Week 76; Week 100, at early termination visit
    21. Baseline to 1 year

    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 trial3
    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 EEA76
    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
    Israel
    Japan
    Mexico
    Peru
    Russian Federation
    Turkey
    United States
    Austria
    Bulgaria
    France
    Germany
    Hungary
    Italy
    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
    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 days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    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: 540
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 360
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 289
    F.4.2.2In the whole clinical trial 900
    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 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 Decision2018-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-09-03
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