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A Study to Comparing SCD411 and Eylea® in Subjects With Wet Age-related Macular Degeneration (AMD)

Sponsor
Sam Chun Dang Pharm. Co. Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04480463
Collaborator
(none)
576
Enrollment
140
Locations
2
Arms
24.6
Anticipated Duration (Months)
4.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Age-related macular degeneration (AMD) is a leading cause of vision loss in adults. Abnormal blood vessels grow under the macula at the back of the eye, and also leak blood and fluid, which damages and scars the macula, affecting vision. The current standard of care for patients with neovascular (exudative / wet) AMD is anti-vascular endothelial growth factor (anti-VEGF) therapy, which prevents or slows down the growth of the abnormal blood vessels. SCD411 is being developed as a biosimilar to the reference product Eylea® (aflibercept), an anti-VEGF drug. The study aims to prove equivalence of SCD411 to Eylea in adults with wet AMD, and will look at safety, tolerance, effectiveness, immune response and the movement of the drug through the body.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
576 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Only the unmasked investigator involved in performing the IVT injections will be unmasked to study treatment. These individuals are not allowed to discuss treatment and/or subject outcome with masked study staff, including the evaluating investigator.
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Aug 13, 2020
Actual Primary Completion Date :
Nov 2, 2021
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: SCD411

Drug: SCD411
IVT (intravitreal) injection
Active Comparator: Aflibercept

Drug: Aflibercept
IVT injection
Other Names:
  • Eylea®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in BCVA (best corrected visual acuity) [Baseline to Week 8]

      Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts

    Secondary Outcome Measures

    1. Change from baseline in BCVA (best corrected visual acuity) [Baseline to Week 52]

      Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts

    2. Percentage of subjects with anti-SCD411 antibodies [Baseline, Weeks 4, 8, 20, 36 and 52]

      Assessed by blood samples

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Provides written informed consent.

    • Clinical diagnosis of wet (neovascular) age-related macular degeneration (AMD).

    • BCVA (best corrected visual acuity) letter score of 73 to 35 at screening and prior to randomization.

    • Women of child-bearing potential with negative serum pregnancy test at screening must agree to use protocol-defined methods of contraception throughout study until 3 months after last injection of aflibercept/SCD411.

    • Males with female partners of child-bearing potential must agree to use protocol-defined methods of contraception and refrain from donating sperm throughout study until 3 months after last injection of aflibercept/SCD411.

    Exclusion Criteria:

    • Any prior eye (study eye and fellow eye) or systemic treatment or surgery for neovascular AMD, except dietary supplements or vitamins.

    • Any prior or current treatment with another investigational agent to great neovascular AMD in the study eye, except dietary supplements or vitamins.

    • Fellow eye shows signed of AMD that may need treatment during study period.

    • Any prior treatment with anti-VEGF agents in both eyes.

    • Blood, scars, atrophy, fibrosis, and neovascularization, based on assessment at screening.

    • Central retina thickness of <300 µm in the study eye.

    • Subretinal hemorrhage.

    • Scar or fibrosis.

    • Scar, fibrosis, or atrophy in the study eye.

    • Presence of retinal pigment epithelial tears or rips involving the macular in the study eye.

    • Cataract in the study eye that, in the Investigator's opinion, interferes with visualization of retina or retinal imaging.

    • Inflammation outside the eyeball in either eye, or within the eyeball of the study eye.

    • History of any vitreous hemorrhage in the study eye.

    • History or clinical evidence of diabetic retinopathy, diabetic macular edema, or any other vascular disease.

    • History of, treatment or surgery for detached retina.

    • History of uncomplicated surgery within the eyeball or around the study eye, except lid surgery.

    • Absence of lens in study eye.

    • Uncontrolled hypertension, defined as systolic blood pressure (BP) >180 mmHg or diastolic BP >100 mmHg under appropriate antihypertensive treatment.

    • Hypersensitivity to aflibercept or medications used in the study (fluorescein, mydriatic eye drops, etc.).

    • Pregnancy or lactation at Screening or at baseline for women of child-bearing potential.

    • History of blood clotting events.

    • History or evidence of cardiac conditions, or inability to perform any physical activity without discomfort; ventricular arrhythmia; and atrial fibrillation.

    • History of laser therapy in the macular region.

    • Any prior or current treatment with corticosteroids inside or immediately around the study eye.

    • Any prior or current treatment involving the macula with photodynamic therapy (PDT) with verteporfin, transpupillary thermotherapy, radiation therapy, or retinal laser treatment in the study eye.

    • Any prior or current treatment with pan-retinal photocoagulation.

    • Any prior or current treatment with ethambutol; deferoxamine and topiramate; tamoxifen, hydroxychloroquine, chloroquine, or vigabatrin; and amiodarone.

    • Any investigational product for the treatment of eye conditions and systemic conditions, 30 days or 5 half-lives (whichever is longer), prior to randomization, and throughout the study, except dietary supplements or vitamins.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SCD Research Site Beverly Hills California United States 90211
    2 SCD Research Site Campbell California United States 95008
    3 SCD Research Site Clearwater Florida United States 33761
    4 SCD Research Site Coral Springs Florida United States 33067
    5 SCD Research Site Fort Myers Florida United States 33912
    6 SCD Research Site Stuart Florida United States 34994
    7 SCD Research Site Winter Haven Florida United States 33880
    8 SCD Research Site Augusta Georgia United States 30909
    9 SCD Research Site Marietta Georgia United States 30060
    10 SCD Research Site Lemont Illinois United States 60439
    11 SCD Research Site Grand Rapids Michigan United States 49546
    12 SCD Research Site Liverpool New York United States 13088
    13 SCD Research Site Springfield Oregon United States 97477
    14 SCD Research Site Rapid City South Dakota United States 57701
    15 SCD Research Site Abilene Texas United States 79606
    16 SCD Research Site Houston Texas United States 77030
    17 SCD Research Site The Woodlands Texas United States 77384
    18 SCD Research Site Willow Park Texas United States 76087
    19 SCD Research Site Castle Hill New South Wales Australia 2154
    20 SCD Research Site Liverpool New South Wales Australia 2170
    21 SCD Research Site Sydney New South Wales Australia 2000
    22 SCD Research Site East Melbourne Victoria Australia 3002
    23 SCD Research Site Nedlands Western Australia Australia 6009
    24 SCD Research Site Sofia Sofia-Grad Bulgaria 1431
    25 SCD Research Site Sofia Sofia-Grad Bulgaria 1784
    26 SCD Research Site Sofia Bulgaria 1618
    27 SCD Research Site Varna Bulgaria 9002
    28 SCD Research Site Pardubice Pardubicky Kraj Czechia 530 02
    29 SCD Research Site Praha Czechia 128 08
    30 SCD Research Site Budapest Hungary 1062
    31 SCD Research Site Budapest Hungary 1085
    32 SCD Research Site Budapest Hungary 1133
    33 SCD Research Site Budapest Hungary 1204
    34 SCD Research Site Debrecen Hungary 4032
    35 SCD Research Site Nyíregyháza Hungary 4400
    36 SCD Research Site Pécs Hungary 7621
    37 SCD Research Site Wardha Maharashtra India 442001
    38 SCD Research Site Bhubaneswar Orissa India 751024
    39 SCD Research Site Jaipur Rajasthan India 302015
    40 SCD Research Site Lucknow Uttar Pradesh India 226001
    41 SCD Research Site Kolkata West Bengal India 700020
    42 SCD Research Site Kolkata West Bengal India 700073
    43 SCD Research Site Haifa Israel 31048
    44 SCD Research Site Haifa Israel 31096
    45 SCD Research Site Haifa Israel 34362
    46 SCD Research Site H̱olon Israel 58100
    47 SCD Research Site Jerusalem Israel 91120
    48 SCD Research Site Kfar Saba Israel 44281
    49 SCD Research Site Nahariya Israel 22100
    50 SCD Research Site Petach Tikva Israel 4941492
    51 SCD Research Site Petah tikva Israel 49100
    52 SCD Research Site Ramat Gan Israel 52621
    53 SCD Research Site Reẖovot Israel 76100
    54 SCD Research Site Tel Aviv Israel 64239
    55 SCD Research Site Tiberias Israel 15208
    56 SCD Research Site Zerifin Israel 70300
    57 SCD Research Site Nagoya Aiti Japan 457-8510
    58 SCD Research Site Kurume Hukuoka Japan 830-0011
    59 SCD Research Site Kobe Hyogo Japan 650-0047
    60 SCD Research Site Nishinomiya Hyogo Japan 663-8501
    61 SCD Research Site Amagasaki Hyôgo Japan 660-8550
    62 SCD Research Site Kagoshima Kogosima Japan 890-8520
    63 SCD Research Site Kyoto Kyôto Japan 607-8062
    64 SCD Research Site Nakagami Okinawa Japan 903-0215
    65 SCD Research Site Chuo Ku Tokyo Japan 104-8560
    66 SCD Research Site Hachiōji Tokyo Japan 193-0998
    67 SCD Research Site Meguro Tokyo Japan 152-8902
    68 SCD Research Site Nerima-ku Tokyo Japan 177-8521
    69 SCD Research Site Ube Yamaguti Japan 755-8505
    70 SCD Research Site Fukuoka Japan 812-0011
    71 SCD Research Site Fukushima Japan 960-1295
    72 SCD Research Site Kita Japan 761-0793
    73 SCD Research Site Nagakute Japan 480-1195
    74 SCD Research Site Niigata Japan 951-8520
    75 SCD Research Site Saga Japan 849-8501
    76 SCD Research Site Sakai Japan 593-8304
    77 SCD Research Site Sakura Japan 285-8741
    78 SCD Research Site Toyama Japan 930-0194
    79 SCD Research Site Cheongju-si Chungcheongbugdo Korea, Republic of 28644
    80 SCD Research Site Guri-si Gyeonggido Korea, Republic of 11923
    81 SCD Research Site Suwon Gyeonggido Korea, Republic of 16499
    82 SCD Research Site Changwon-Si Gyeongsangnamdo Korea, Republic of 51472
    83 SCD Research Site Busan Korea, Republic of 48108
    84 SCD Research Site Busan Korea, Republic of 49201
    85 SCD Research Site Busan Korea, Republic of 49241
    86 SCD Research Site Busan Korea, Republic of 49267
    87 SCD Research Site Daegu Korea, Republic of 41944
    88 SCD Research Site Daegu Korea, Republic of 42415
    89 SCD Research Site Daegu Korea, Republic of 42601
    90 SCD Research Site Daejeon Korea, Republic of 35015
    91 SCD Research Site Daejeon Korea, Republic of 35365
    92 SCD Research Site Gwangju Korea, Republic of 61469
    93 SCD Research Site Incheon Korea, Republic of 21565
    94 SCD Research Site Incheon Korea, Republic of 22332
    95 SCD Research Site Jinju-si Korea, Republic of 52727
    96 SCD Research Site Seoul Korea, Republic of 02447
    97 SCD Research Site Seoul Korea, Republic of 02841
    98 SCD Research Site Seoul Korea, Republic of 03080
    99 SCD Research Site Seoul Korea, Republic of 05355
    100 SCD Research Site Seoul Korea, Republic of 05505
    101 SCD Research Site Seoul Korea, Republic of 06198
    102 SCD Research Site Seoul Korea, Republic of 06351
    103 SCD Research Site Seoul Korea, Republic of 07441
    104 SCD Research Site Seoul Korea, Republic of 7061
    105 SCD Research Site Jelgava Latvia LV-3001
    106 SCD Research Site Riga Latvia LV-1002
    107 SCD Research Site Riga Latvia LV-1006
    108 SCD Research Site Riga Latvia LV-1009
    109 SCD Research Site Wałbrzych Dolnoslaskie Poland 58-309
    110 SCD Research Site Wrocław Dolnoslaskie Poland 50-556
    111 SCD Research Site Wrocław Dolnoslaskie Poland 50-981
    112 SCD Research Site Warszawa Mazowieckie Poland 01-258
    113 SCD Research Site Warszawa Mazowieckie Poland 01-364
    114 SCD Research Site Rzeszów Podkarpackie Poland 35-017
    115 SCD Research Site Gdańsk Pomorskie Poland 80-809
    116 SCD Research Site Katowice Slaskie Poland 40-514
    117 SCD Research Site Katowice Slaskie Poland 40-594
    118 SCD Research Site Olsztyn Warminsko-marzurskie Poland 10-424
    119 SCD Research Site Bydgoszcz Poland 85-631
    120 SCD Research Site Bydgoszcz Poland 85-870
    121 SCD Research Site Lublin Poland 20-079
    122 SCD Research Site Warszawa Poland 00-215
    123 SCD Research Site Warszawa Poland 01-249
    124 SCD Research Site Moscow Russian Federation 101750
    125 SCD Research Site Moscow Russian Federation 127473
    126 SCD Research Site Moscow Russian Federation 127486
    127 SCD Research Site Novosibirsk Russian Federation 630087
    128 SCD Research Site Bratislava Slovakia 826 06
    129 SCD Research Site Poprad Slovakia 058 45
    130 SCD Research Site Trebišov Slovakia 075 01
    131 SCD Research Site Žilina Slovakia 012 07
    132 SCD Research Site Sant Cugat Del Vallès Barcelona Spain 08195
    133 SCD Research Site Barcelona Spain 08022
    134 SCD Research Site Barcelona Spain 08025
    135 SCD Research Site Bilbao Spain 48006
    136 SCD Research Site Bilbao Spain 48010
    137 SCD Research Site Majadahonda Spain 28222
    138 SCD Research Site Valencia Spain 46014
    139 SCD Research Site Valladolid Spain 47012
    140 SCD Research Site Zaragoza Spain 50009

    Sponsors and Collaborators

    • Sam Chun Dang Pharm. Co. Ltd.

    Investigators

    • Study Director: Byung Jhip Ha, Sam Chun Dang Pharm. Co. Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sam Chun Dang Pharm. Co. Ltd.
    ClinicalTrials.gov Identifier:
    NCT04480463
    Other Study ID Numbers:
    • SCD411-CP101
    First Posted:
    Jul 21, 2020
    Last Update Posted:
    May 13, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sam Chun Dang Pharm. Co. Ltd.
    Age-related macular degeneration
    AMD
    Neovascular
    Exudative
    Additional relevant MeSH terms:
    Macular Degeneration
    Wet Macular Degeneration
    Aflibercept

    Study Results

    No Results Posted as of May 13, 2022