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    Summary
    EudraCT Number:2019-004132-37
    Sponsor's Protocol Code Number:SCD411-CP101
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-06-02
    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 ConcernedBulgarian Drug 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
    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
    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 SponsorSamChunDang 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/ city Seoul
    B.5.3.3Post code06643
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number+82 31-888-6367
    B.5.5Fax number+82 31-888-6366
    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.3.9.3Other descriptive nameAFLIBERCEPT
    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.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
    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 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
    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
    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
    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
    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 ≥50 years.
    3. Active choroidal subfoveal, juxtafoveal, or extrafoveal 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.
    7. The area of CNV making up either 50% or more of the total lesion area and confirmed by the central reading center.
    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 both eyes.5.Total lesion size>30.5mm2,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<300μm 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 4wks prior to the Screening Visit.14Presence of other causes of CNV in the study eye as confirmed by central reading center.15History 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.17History of retinal detachment,treatment,or surgery for retinal detachment in the study eye.18History 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 3months of Day1 on the study eye,except lid surgery,which may not have taken place within 1month of Day1.20.Presence of aphakia in the study eye.21History of glaucoma-filtering surgery within 3months of D1 in the study eye.Antiglaucoma laser surgeries will not be considered exclusionary.22History of corneal transplant in the study eye.23History or evidence of any other clinically significant disorder,condition or disease(eg,co-existence of RVO,radiation retinopathy,diabetic retinopathy,glaucoma under treatment) in the study eye that,in the opinion of the investigator,would pose a risk to subject safety or interfere with the study evaluation,procedure or complication.24Uncontrolled hypertension defined as systolic BP>160mmHg or diastolic BP>100mmHg under appropriate antihypertensive treatment.25Hypersensitivity to aflibercept or medications used in this study.26Pregnancy or lactation at the Screening Visit and/or at baseline for women of child-bearing potential.27Any contraindication to IVT injection according to the investigator’s clinical judgment.28History of thrombotic events29. History or evidence of cardiac conditions with congestive cardiac failure resulting in marked limitation on physical activity,or inability to perform any physical activity without discomfort, subjects with ventricular arrhythmia requiring ongoing treatment or subjects with atrial fibrillation.30History of laser therapy in the macular region in the study eye.31.Any prior or concomitant treatment with IVT corticosteroids injection,IVT corticosteroid implant,subtenon corticosteroids,or peribulbar corticosteroids in the study eye 6months before the Screening Visit.32Any prior or concomitant treatment involving the macula with photodynamic therapy(PDT) with verteporfin,transpupillary thermotherapy,radiation therapy,or retinal laser treatment(eg,focal laser photocoagulation)in the study eye.33Any prior or concomitant treatment with pan-retinal photocoagulation 90days in the study eye before the Screening Visit.34Any concomitant or prior treatment with ethambutol(2wks prior to randomization);deferoxamine and topiramate(4wks prior to randomization);tamoxifen,hydroxychloroquine,chloroquine,or vigabatrin(8wks prior to randomization),and amiodarone(12wks prior to randomization).35.Any investigational product for the treatment of ocular conditions(in either eye) and systemic conditions 30days or 5half-lives(whichever is longer),prior to randomization,and throughout the study,except dietary supplements or vitamins.36Intraocular pressure≥25mmHg in spite of anti-glaucoma treatment.37Any prior or ongoing systemic medical condition or clinically significant screening laboratory value,or confound data interpretation throughout the study period.
    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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Week 8
    E.5.2Secondary end point(s)
    Secondary endpoints:
    • Safety endpoints include AEs, vital signs, and laboratory assessments up to Week 52.
    Efficacy:
    • 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.
    • Immunogenicity endpoints include the evaluation of development of
    anti-SCD411 or anti-aflibercept antibodies using blood samples taken at
    Baseline, at Weeks 4, 8, 20, 36, and 52. Neutralizing antibodies will be
    tested when ADA results are confirmed to be positive.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at week 8, at week 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
    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 concerned2
    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 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
    Australia
    India
    Israel
    Japan
    Korea, Republic of
    Russian Federation
    United States
    Bulgaria
    Czechia
    Hungary
    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
    The end of the study is defined as the date of the last visit of the
    last subject in the study.
    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 months8
    E.8.9.1In the Member State concerned days24
    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
    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 Decision2020-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-09-08
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