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    Summary
    EudraCT Number:2021-004530-11
    Sponsor's Protocol Code Number:ALT-L9-03
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-01-04
    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 number2021-004530-11
    A.3Full title of the trial
    A Randomized, Phase 3, Double Masked, Parallel Group, Multicenter Study to Compare the Efficacy and Safety of ALT L9 Versus Eylea® in Patients With Neovascular Age Related Macular Degeneration (ALTERA)
    Randomizált, 3. fázisú, kétszeresen maszkolt, párhuzamos csoportos, multicentrikus vizsgálat az ALT-L9 hatásosságának és biztonságosságának Eylea®-val szembeni összehasonlítására neovaszkuláris időskori makuladegenerációban szenvedő betegeknél (ALTERA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, Phase 3, Double Masked, Parallel Group, Multicenter Study to Compare the Efficacy and Safety of ALT L9 Versus Eylea®
    A.3.2Name or abbreviated title of the trial where available
    ALTERA
    A.4.1Sponsor's protocol code numberALT-L9-03
    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 SponsorAltos Biologics Inc.
    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 supportAltos Biologics Inc.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAltos Biologics Inc.
    B.5.2Functional name of contact pointKoh Hyojin
    B.5.3 Address:
    B.5.3.1Street Address8F, 15, Teheran-ro 84-gil, Gangnam-gu
    B.5.3.2Town/ citySeoul
    B.5.3.3Post code06179
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number+8222039 9522
    B.5.6E-mailhyojin.koh@altosbio.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 nameAflibercept biosimilar
    D.3.2Product code ALT-L9
    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.3.9.2Current sponsor codeALT-L9
    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 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.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.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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.3.9.4EV 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 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 Age Related Macular Degeneration
    E.1.1.1Medical condition in easily understood language
    Eye disease that can blur 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 LLT
    E.1.2Classification code 10075568
    E.1.2Term Wet age-related macular degeneration
    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
    The primary objective of the study is to demonstrate that the biosimilar candidate ALT-L9 2 mg/50 µL is equivalent to Eylea® (aflibercept) in subjects with wet (neovascular) age related macular degeneration (nAMD) in terms of best corrected visual acuity (BCVA).
    E.2.2Secondary objectives of the trial
    - Evaluate the efficacy of ALT-L9 versus Eylea® in subjects with nAMD based on central subfield thickness (CST), area of choroidal neovascularization (CNV), and leakage from CNV lesion
    - Evaluate the safety of ALT-L9 versus Eylea®
    - Evaluate the systemic exposure of ALT-L9 versus Eylea® in subjects participating in pharmacokinetic (PK) evaluation
    - Evaluate the immunogenicity of ALT-L9 versus Eylea®
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able and willing to read, understand, and sign the informed consent form (ICF). The signed ICF must be obtained before any study-related procedures are performed. The subject must be willing and able to undertake all scheduled visits and assessments as judged by the investigator
    2. Subjects aged 50 years or older at the time of screening, when obtaining written informed consent
    3. BCVA of 20/40 to 20/200 (both inclusive) in the study eye using the ETDRS letter chart (≤73 and ≥34 ETDRS letters) at screening and Day 1 before randomization
    4. Newly diagnosed, treatment-naive, active subfoveal or juxtafoveal CNV lesion secondary to AMD in the study eye. Active CNV means the presence of leakage as evidenced by FA and intraretinal or subretinal fluid as evidenced by SD-OCT that is confirmed by the CRC during screening
    5. Total lesion area of ≤9.0 disc areas (≤22.86 mm2) in size (including blood, scars, and neovascularization) in the study eye as assessed by FA and confirmed by the CRC before randomization
    6. The area of CNV must be ≥50% of the total lesion area in the study eye confirmed by the CRC before randomization
    7. Female subjects must agree to use a highly effective method of contraception consistent with local regulations during the course of the study and for at least 90 days after the last dose of the study drug (excluding women who are not of childbearing potential). Refer to Appendix 1 for more details.
    Contraception is not required if the subject or his/her partner has been surgically sterilized with documentation of surgical success at least 24 weeks before the date of informed consent.
    a. Male subjects of reproductive potential must be willing to completely abstain from sexual intercourse or agree to use an appropriate method of contraception from the time of signing the ICF and for the duration of study participation through 90 days after the last dose of the study drug. (The investigator and each subject will determine the appropriate method of contraception for the subject during study participation.) Refer to Appendix 1 for more details
    b. Subjects must agree to refrain from donating sperm (male subjects) and ova (female subjects) from screening through 90 days after receiving the last dose of study drug.
    E.4Principal exclusion criteria
    Considerations for Study Eye
    1. Previous ocular treatment/surgery (including any macular laser or photodynamic therapy) for nAMD in the study eye
    2. Any previous IVT anti-VEGF treatment (eg, bevacizumab, aflibercept, ranibizumab, or brolucizumab) in the study eye
    3. Subretinal or intraretinal hemorrhage in the study eye involving 50% or more of the total lesion area, or with a size of ≥1 disc area (≥2.54 mm2) if involving the fovea, as assessed by FA and confirmed by the CRC
    4. Subfoveal fibrosis or atrophy in the study eye as assessed by FA and confirmed by the CRC
    5. Fibrosis exceeding 50% of the total lesion size in the study eye as assessed by FA and confirmed by the CRC
    6. Retinal pigment epithelial rips or tears involving the macula in the study eye as assessed by FA or SD-OCT and confirmed by the CRC
    7. Previous IVT surgery or scleral buckling in the study eye
    8. Other intraocular surgery (including cataract surgery, laser-assisted in situ keratomileusis [LASIK], or Yttrium Aluminum Garnet [YAG] laser) or periocular surgery in the study eye within 90 days before screening, except for eyelid surgery within 30 days before screening
    9. Corneal transplant in the study eye
    10. Any concurrent intraocular condition in the study eye (eg, cataract or diabetic retinopathy) that, in the opinion of the investigator, could require treatment during the study period to prevent or treat loss of visual acuity or could interfere with visual acuity, optical imaging, or safety assessments defined by the study protocol
    11. Aphakia or absence of the posterior capsule in the study eye, unless it occurred as a result of a YAG laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation
    12. Current vitreous hemorrhage in the study eye
    13. History of retinal detachment in the study eye
    14. History of macular hole in the study eye
    15. Uncontrolled ocular hypertension in the study eye, defined as an IOP of ≥25 mm Hg despite treatment with antiglaucoma medication
    16. Presence of advanced glaucoma or optic neuropathy that involves or threatens the central visual field in the study eye
    17. History of any glaucoma filtering surgery, corneal transplantation, or panretinal photocoagulation; such therapies are not allowed during the study in the study eye
    18. Spherical equivalent of the refractive error in the study eye demonstrating more than 8 diopters of myopia
    19. Use of ongoing topical ocular corticosteroids at screening or administrated for ≥30 consecutive days in the study eye within 90 days before screening, or the use of intraocular corticosteroid implants in the study eye within 180 days before screening for Ozurdex® or within 3 years before screening for Iluvien®
    20. Prior therapeutic radiation in the study eye region

    Considerations for Fellow Eye
    21. Subjects with any diagnosis and/or signs of nAMD requiring IVT anti VEGF treatment in the fellow eye at screening or, in the opinion of the investigator, who are expected to need such treatments, at least before the evaluation of the primary efficacy endpoint
    22. Use of any anti-VEGF treatment in the fellow eye within 90 days before screening
    23. The BCVA of the fellow eye is worse than 20/200 (or <34 ETDRS letters)

    Considerations for Either Eye
    24. CNV in either eye as a result of non-AMD causes (including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis) as assessed by FA and confirmed by the CRC
    25. Presence or history of scleromalacia in either eye
    26. Active or recent (within 28 days before screening) intraocular or periocular inflammation or infection in either eye, including but not limited to conjunctivitis, keratitis, scleritis, or endophthalmitis
    27. History of idiopathic or autoimmune-associated uveitis in either eye

    Considerations for Systemic Treatments and General Conditions
    28. Any systemic treatment to treat nAMD within 30 days before screening; such treatment or therapy will not be allowed during the study period. However, dietary supplements, vitamins, or minerals will be allowed during study
    29. Any previous systemic anti-VEGF therapy within 180 days before screening
    30. Use of systemic corticosteroids (except short-term [<14 consecutive days] oral corticosteroids or; inhaled, nasal, intra articular, and dermal corticosteroids) within 180 days before screening or a plan for the use of systemic corticosteroids during the course of the study
    31. Use of medications known to be toxic to the lens, retina, or optic nerve at screening (such medications will not be allowed during the study period)

    Refer to protocol for the entire list of exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in BCVA at Week 8 as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 8
    E.5.2Secondary end point(s)
    * Change from baseline in BCVA letter score in the study eye overtime up to Week 32 and Week 52 using the ETDRS protocol
    * Proportion of subjects with a loss of at least 5, 10, or 15 letters inBCVA letter score in the study eye over time up to Week 32 andWeek 52, compared with baseline, using the ETDRS protocol
    * Proportion of subjects with a gain of at least 5, 10, or 15 letters in BCVA letter score in the study eye over time up to Week 32 and Week 52, compared with baseline, using the ETDRS protocol
    * Change from baseline in CST in the study eye over time up to Week 4, Week 32, and Week 52, as measured by spectral domain-optical coherence tomography (SD-OCT)
    * Proportion of subjects with existing intraretinal or subretinal fluid in the study eye over time up to Week 4, Week 32, and Week 52 compared with baseline, as measured by SD-OCT
    * Change from baseline in total size of CNV area in the study eye over time up to Week 32 and Week 52, as measured by fluorescein angiography (FA)
    * Proportion of subjects with active CNV leakage in the study eye over time up to Week 32 and Week 52, compared with baseline, as measured by FA
    * Proportion of subjects with stability of vision (gained ≤5 letters or lost ≤5 letters) in BCVA letter score in the study eye over time between Week 32 and Week 52, compared with baseline, using the ETDRS protocol among subjects who underwent a second randomization versus non switched subjects
    E.5.2.1Timepoint(s) of evaluation of this end point
    Refer to protocol Timepoints Section
    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 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
    Immunogenicity
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA56
    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
    Japan
    Korea, Republic of
    Austria
    Estonia
    Latvia
    Lithuania
    Poland
    Bulgaria
    Spain
    Czechia
    Hungary
    Russian Federation
    Slovakia
    Ukraine
    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 years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 222
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 222
    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 state56
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 303
    F.4.2.2In the whole clinical trial 444
    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 Decision2022-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-27
    P. End of Trial
    P.End of Trial StatusCompleted
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