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    Summary
    EudraCT Number:2020-001174-30
    Sponsor's Protocol Code Number:MR41926
    National Competent Authority:Croatia - MIZ
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-09-02
    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 ConcernedCroatia - MIZ
    A.2EudraCT number2020-001174-30
    A.3Full title of the trial
    AN EXPLORATORY, PROSPECTIVE,
    MULTI-CENTER, OPEN-LABEL, SINGLE-ARM,
    INTERVENTIONAL, PHASE IIB STUDY TO
    INVESTIGATE AQUEOUS HUMOR AND
    MULTIMODAL IMAGING BIOMARKERS IN
    TREATMENT-NAÏVE PATIENTS WITH DIABETIC
    MACULAR EDEMA TREATED WITH FARICIMAB
    (RO6867461) - ALTIMETER STUDY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Investigate Aqueous Humor and Multimodal Imaging Biomarkers in Treatment-Naïve Patients with Diabetic Macular Edema Treated with Faricimab (RO6867461) - Altimeter Study
    A.3.2Name or abbreviated title of the trial where available
    ALIMETER
    A.4.1Sponsor's protocol code numberMR41926
    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.Hoffman-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.Hoffman La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffman 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 nameRecombinant humanized anti-human VEGF-A and anti-human Ang2-ab
    D.3.9.4EV Substance CodeSUB194079
    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.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, a complication of Diabetic Retinopathy

    E.1.1.1Medical condition in easily understood language
    DME is a complication of diabetes caused by fluid accumulation in the macula that can affect the fovea.
    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
    This is an exploratory, prospective, multicenter, open-label, single-arm, interventional, Phase IIb study designed to explore the associations over time between clinical assessments, multimodal imaging assessments, AH biomarker patterns, and genetic polymorphisms in patients with DME who are treated with faricimab (RO6867461).
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Informed Consent
    1. Signed ICF prior to any study-related assessments
    o All patients are able and willing to provide written informed consent and to comply with the study protocol according to International Council for Harmonisation (ICH) and local regulations.
    o Patients are willing to allow AH collection and in the opinion of the Investigator, sampling of >90 μl of AH seems feasible and safe.
    2. Ability to comply with the study protocol, in the Investigator’s judgment
    Age
    3. Age ≥18 years at the time of signing the ICF
    Type of DME Patients and Disease Characteristics
    4. Diagnosis of diabetes mellitus (Type 1 or Type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association and
    o Current regular use of insulin or other injectable drugs (e.g., dulaglutide and liraglutide) for the treatment of diabetes
    and/or
    o Current regular use of oral anti-hyperglycemic agents for the treatment of diabetes
    5. Hemoglobin A1c (HbA1c) ≤10% (historic values up to 2 months before the screening visit will be permissible; otherwise, the study site may collect a sample for analysis at screening)
    6. Patients who are IVT treatment-naïve in the study eye (i.e., have not received previous treatment with any anti-VEGF IVT or any corticosteroids periocular or IVT in the study eye).
    Ocular Inclusion Criteria for Study Eye
    7. Diabetic macular edema (DME) defined as macular thickening by spectral-domain optical coherence tomography (SD-OCT) involving the center of the macula: CST of ≥325 μm with Spectralis® (Heidelberg Engineering, Heidelberg, Germany) at screening. This inclusion criterion is to be assessed by the central reading center (CRC).
    8. Moderately severe to severe non-proliferative DR (NPDR) (defined as any ETDRS DRSS from 47A through 53E [Ip et al. 2012]) or mild or moderate proliferative DR (PDR) (defined as ETDRS DRSS 60 through 65C [Ip et al. 2012]). This inclusion criterion is to be assessed by the CRC.
    9. Decreased VA attributable primarily to DME, with BCVA letter score of 75 to 20 letters (both inclusive) on ETDRS-like charts at the screening visit
    10. Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis
    Contraception
    11. For women of childbearing potential (WOCBP): agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined below:
    o Women must remain abstinent or use contraceptive methods with a failure rate of <1% per year during the treatment period and for at least 3 months after the final dose of faricimab.
    o A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the Investigator (e.g., Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.
    o Examples of contraceptive methods with a failure rate of <1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
    o Contraception methods that do not result in a failure rate of <1% per year such as male or female condom with or without spermicide; and cap, diaphragm, or sponge with spermicide are not acceptable.
    o The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local ICF.
    E.4Principal exclusion criteria
    Medical Conditions
    • Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to Day 1
    • Any known hypersensitivity to any of the components in the faricimab injection, dilating eye drops, or any of the anesthetics and antimicrobial preparations used by the patient during the study
    • Any major illness or major surgical procedure within 1 month before the Day 1. One re-screening for this criterion is permitted
    • History of other diseases, other non-diabetic metabolic dysfunction, physical examination finding, historical or current clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of the faricimab or that might affect interpretation of the results of the study or renders the patient at high-risk for treatment complications, in the opinion of the Investigator
    • Active cancer within the past 12 months prior to Day 1 except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of ≤6 and a stable prostate-specific antigen for >12 months
    • Stroke or myocardial infarction within 12 months prior to the Day 1. One re-screening for this criterion is permitted
    • Any febrile illness within 1 week prior to Day 1. One re-screening for this criterion is permitted
    • Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of faricimab
    • WOCBP must have a negative serum pregnancy test result within 28 days prior to initiation of faricimab and a negative urine pregnancy test at the baseline visit
    • Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis within 6 months prior to Day 1 or anticipated to require hemodialysis or peritoneal dialysis at any time during the study
    • Any condition resulting in a compromised immune system that is likely to impact the AH inflammatory biomarkers. In case of doubt, the Investigator should consult with the Medical Monitor
    Prior/Concomitant Therapy
    • Patients who are currently enrolled in or have participated in any other clinical study involving an investigational product or device, or in any other type of medical research, within 3 months or 5 half-lives prior to Day 1 and up to completion of the current study
    • Substance abuse occurring within 12 months prior to screening, in the Investigator's judgment
    • Use of systemic immunomodulatory treatments within 6 months or 5 half-lives prior to Day 1, systemic corticosteroids within 1 month prior to Day 1
    • Any prior or concomitant systemic anti-VEGF treatment within 6 months or 5 half-lives prior to Day 1
    • Use of systemic medications known to be toxic to the lens, retina or optic nerve used during the 6-month period or 5 half-lives prior to Day 1 or likely need to be used
    • Received a blood transfusion within 3 months prior to the screening visit, received any treatment that leads to immunosuppression within 6 months or 5 half-lives prior to Day 1
    • Ocular Exclusion Criteria for Study Eye
    • Mild or moderate NPDR. This exclusion criterion is to be assessed by the CRC
    • Any history of or ongoing rubeosis iridis
    • Any panretinal photocoagulation or macular laser photocoagulation treatment received in the study eye prior to the screening visit or expected to be received between the screening visit and Day 1
    • Any history of treatment with anti-VEGF or any periocular or IVT corticosteroids in the study eye and no such treatment planned for the time between screening and Day 1
    • Any treatment for dry eye disease in the last month prior to Day 1. Lubricating eye drops and ointments are permitted
    • Any treatment with anti-inflammatory eye drops within 1 month prior to Day 1
    • Any intraocular surgery within 3 months prior to Day 1 or any planned surgery during the study, any glaucoma surgery prior to the screening visit
    • History of vitreoretinal surgery/pars plana vitrectomy, corneal transplant, or radiotherapy
    • Any active or suspected ocular or periocular infections on Day 1
    • Any presence of active intraocular inflammation on Day 1 or any history of intraocular inflammation
    • Any history of idiopathic, infectious, or noninfectious uveitis
    • Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision
    • Any current ocular condition or other causes of visual impairment for which, in the opinion of the Investigator, VA loss would not improve from resolution of macular edema
    Ocular Exclusion Criteria for Fellow Eye
    • Patient is currently receiving treatment with brolucizumab or bevacizumab in the non-study eye and is unwilling to switch to a protocol allowed non-study eye treatment during the study
    • Any previous treatment with Iluvien® or Retisert® in the non-study eye
    • Non-functioning non-study eye
    E.5 End points
    E.5.1Primary end point(s)
    1.Change in DRSS between day one and day 112
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 29 weeks

    E.5.2Secondary end point(s)
    n/a
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Exploratory
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    United States
    Croatia
    Germany
    Italy
    Poland
    United Kingdom
    Argentina
    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
    LSVS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 31
    F.4.2.2In the whole clinical trial 80
    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 Decision2021-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-12-22
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