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

October 6, 2023 updated by: Sam Chun Dang Pharm. Co. Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

576

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • SCD Research Site
      • Sydney, New South Wales, Australia, 2000
        • SCD Research Site
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • SCD Research Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • SCD Research Site
  • Bulgaria
      • Sofia, Bulgaria, 1618
        • SCD Research Site
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgaria, 1431
        • SCD Research Site
      • Sofia, Sofia-Grad, Bulgaria, 1784
        • SCD Research Site
  • Czechia
      • Praha, Czechia, 128 08
        • SCD Research Site
    • Pardubicky Kraj
      • Pardubice, Pardubicky Kraj, Czechia, 530 02
        • SCD Research Site
  • Hungary
      • Budapest, Hungary, 1062
        • SCD Research Site
      • Budapest, Hungary, 1085
        • SCD Research Site
      • Budapest, Hungary, 1133
        • SCD Research Site
      • Budapest, Hungary, 1204
        • SCD Research Site
      • Debrecen, Hungary, 4032
        • SCD Research Site
      • Nyíregyháza, Hungary, 4400
        • SCD Research Site
      • Pécs, Hungary, 7621
        • SCD Research Site
  • India
    • Maharashtra
      • Wardha, Maharashtra, India, 442001
        • SCD Research Site
    • Orissa
      • Bhubaneswar, Orissa, India, 751024
        • SCD Research Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302015
        • SCD Research Site
    • Telangana
      • Hyderabad, Telangana, India, 500018
        • SCD Research Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226001
        • SCD Research Site
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • SCD Research Site
      • Kolkata, West Bengal, India, 700073
        • SCD Research Site
  • Israel
      • Haifa, Israel, 31096
        • SCD Research Site
      • Haifa, Israel, 34362
        • SCD Research Site
      • H̱olon, Israel, 58100
        • SCD Research Site
      • Jerusalem, Israel, 91120
        • SCD Research Site
      • Kfar Saba, Israel, 44281
        • SCD Research Site
      • Nahariya, Israel, 22100
        • SCD Research Site
      • Petah tikva, Israel, 49100
        • SCD Research Site
      • Ramat Gan, Israel, 52621
        • SCD Research Site
      • Reẖovot, Israel, 76100
        • SCD Research Site
      • Tel Aviv, Israel, 64239
        • SCD Research Site
      • Tiberias, Israel, 15208
        • SCD Research Site
      • Zerifin, Israel, 70300
        • SCD Research Site
  • Japan
      • Fukuoka, Japan, 812-0011
        • SCD Research Site
      • Fukushima, Japan, 960-1295
        • SCD Research Site
      • Kita, Japan, 761-0793
        • SCD Research Site
      • Nagakute, Japan, 480-1195
        • SCD Research Site
      • Niigata, Japan, 951-8520
        • SCD Research Site
      • Saga, Japan, 849-8501
        • SCD Research Site
      • Sakai, Japan, 593-8304
        • SCD Research Site
      • Sakura, Japan, 285-8741
        • SCD Research Site
      • Toyama, Japan, 930-0194
        • SCD Research Site
    • Aiti
      • Nagoya, Aiti, Japan, 457-8510
        • SCD Research Site
    • Hukuoka
      • Kurume, Hukuoka, Japan, 830-0011
        • SCD Research Site
    • Hyogo
      • Kobe, Hyogo, Japan, 650-0047
        • SCD Research Site
      • Nishinomiya, Hyogo, Japan, 663-8501
        • SCD Research Site
    • Hyôgo
      • Amagasaki, Hyôgo, Japan, 660-8550
        • SCD Research Site
    • Kogosima
      • Kagoshima, Kogosima, Japan, 890-8520
        • SCD Research Site
    • Kyôto
      • Kyoto, Kyôto, Japan, 607-8062
        • SCD Research Site
    • Okinawa
      • Nakagami, Okinawa, Japan, 903-0215
        • SCD Research Site
    • Tokyo
      • Chuo Ku, Tokyo, Japan, 104-8560
        • SCD Research Site
      • Hachiōji, Tokyo, Japan, 193-0998
        • SCD Research Site
      • Meguro, Tokyo, Japan, 152-8902
        • SCD Research Site
      • Nerima-ku, Tokyo, Japan, 177-8521
        • SCD Research Site
    • Yamaguti
      • Ube, Yamaguti, Japan, 755-8505
        • SCD Research Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 48108
        • SCD Research Site
      • Busan, Korea, Republic of, 49201
        • SCD Research Site
      • Busan, Korea, Republic of, 49241
        • SCD Research Site
      • Busan, Korea, Republic of, 49267
        • SCD Research Site
      • Daegu, Korea, Republic of, 41944
        • SCD Research Site
      • Daegu, Korea, Republic of, 42415
        • SCD Research Site
      • Daegu, Korea, Republic of, 42601
        • SCD Research Site
      • Daejeon, Korea, Republic of, 35015
        • SCD Research Site
      • Daejeon, Korea, Republic of, 35365
        • SCD Research Site
      • Gwangju, Korea, Republic of, 61469
        • SCD Research Site
      • Incheon, Korea, Republic of, 21565
        • SCD Research Site
      • Incheon, Korea, Republic of, 22332
        • SCD Research Site
      • Jinju-si, Korea, Republic of, 52727
        • SCD Research Site
      • Seoul, Korea, Republic of, 02447
        • SCD Research Site
      • Seoul, Korea, Republic of, 02841
        • SCD Research Site
      • Seoul, Korea, Republic of, 03080
        • SCD Research Site
      • Seoul, Korea, Republic of, 05355
        • SCD Research Site
      • Seoul, Korea, Republic of, 05505
        • SCD Research Site
      • Seoul, Korea, Republic of, 06198
        • SCD Research Site
      • Seoul, Korea, Republic of, 06351
        • SCD Research Site
      • Seoul, Korea, Republic of, 07441
        • SCD Research Site
      • Seoul, Korea, Republic of, 7061
        • SCD Research Site
    • Chungcheongbugdo
      • Cheongju-si, Chungcheongbugdo, Korea, Republic of, 28644
        • SCD Research Site
    • Gyeonggido
      • Guri-si, Gyeonggido, Korea, Republic of, 11923
        • SCD Research Site
      • Suwon, Gyeonggido, Korea, Republic of, 16499
        • SCD Research Site
    • Gyeongsangnamdo
      • Changwon-Si, Gyeongsangnamdo, Korea, Republic of, 51472
        • SCD Research Site
  • Latvia
      • Jelgava, Latvia, LV-3001
        • SCD Research Site
      • Riga, Latvia, LV-1002
        • SCD Research Site
      • Riga, Latvia, LV-1006
        • SCD Research Site
      • Riga, Latvia, LV-1009
        • SCD Research Site
  • Poland
      • Bydgoszcz, Poland, 85-631
        • SCD Research Site
      • Bydgoszcz, Poland, 85-870
        • SCD Research Site
      • Lublin, Poland, 20-079
        • SCD Research Site
      • Warszawa, Poland, 00-215
        • SCD Research Site
    • Dolnoslaskie
      • Wałbrzych, Dolnoslaskie, Poland, 58-309
        • SCD Research Site
      • Wrocław, Dolnoslaskie, Poland, 50-556
        • SCD Research Site
      • Wrocław, Dolnoslaskie, Poland, 50-981
        • SCD Research Site
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 01-258
        • SCD Research Site
      • Warszawa, Mazowieckie, Poland, 01-364
        • SCD Research Site
    • Podkarpackie
      • Rzeszów, Podkarpackie, Poland, 35-017
        • SCD Research Site
    • Pomorskie
      • Gdańsk, Pomorskie, Poland, 80-809
        • SCD Research Site
    • Slaskie
      • Katowice, Slaskie, Poland, 40-514
        • SCD Research Site
      • Katowice, Slaskie, Poland, 40-594
        • SCD Research Site
    • Warminsko-marzurskie
      • Olsztyn, Warminsko-marzurskie, Poland, 10-424
        • SCD Research Site
  • Russian Federation
      • Moscow, Russian Federation, 101750
        • SCD Research Site
      • Moscow, Russian Federation, 127473
        • SCD Research Site
      • Moscow, Russian Federation, 127486
        • SCD Research Site
      • Novosibirsk, Russian Federation, 630087
        • SCD Research Site
  • Slovakia
      • Bratislava, Slovakia, 826 06
        • SCD Research Site
      • Poprad, Slovakia, 058 45
        • SCD Research Site
      • Trebišov, Slovakia, 075 01
        • SCD Research Site
      • Žilina, Slovakia, 012 07
        • SCD Research Site
  • Spain
      • Barcelona, Spain, 08022
        • SCD Research Site
      • Barcelona, Spain, 08025
        • SCD Research Site
      • Bilbao, Spain, 48006
        • SCD Research Site
      • Bilbao, Spain, 48010
        • SCD Research Site
      • Majadahonda, Spain, 28222
        • SCD Research Site
      • Valencia, Spain, 46014
        • SCD Research Site
      • Valladolid, Spain, 47012
        • SCD Research Site
      • Zaragoza, Spain, 50009
        • SCD Research Site
    • Barcelona
      • Sant Cugat Del Vallès, Barcelona, Spain, 08195
        • SCD Research Site
  • United States
    • California
      • Campbell, California, United States, 95008
        • SCD Research Site
    • Florida
      • Clearwater, Florida, United States, 33761
        • SCD Research Site
      • Coral Springs, Florida, United States, 33067
        • SCD Research Site
      • Fort Myers, Florida, United States, 33912
        • SCD Research Site
      • Stuart, Florida, United States, 34994
        • SCD Research Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • SCD Research Site
    • Illinois
      • Lemont, Illinois, United States, 60439
        • SCD Research Site
    • New York
      • Liverpool, New York, United States, 13088
        • SCD Research Site
    • Oregon
      • Springfield, Oregon, United States, 97477
        • SCD Research Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • SCD Research Site
    • Texas
      • Abilene, Texas, United States, 79606
        • SCD Research Site
      • Willow Park, Texas, United States, 76087
        • SCD Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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. In addition, fellow eye should not be less than 35 letter score using the ETDRS chart or 2702 series number chart.
  • 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.
  • Total lesion size >30.5 mm2, Blood, scars, atrophy, fibrosis, and neovascularization, based on assessment at screening.
  • Central retina thickness of <300 µm in the study eye.
  • Subretinal hemorrhage that is either 50% or more of the total lesion area.
  • Scar or fibrosis making up >50% of the total lesion.
  • Scar, fibrosis, or atrophy involving the center of the fovea 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 have Lens Opacity Classification System II (LOCS II) grade IV cataract in the study eye or 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) >160 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.
  • Intraocular pressure ≥25 mmHg in spite of anti-glaucoma treatment.
  • Any prior or ongoing systemic medical condition (including but not limited to infectious, inflammatory, psychiatric, neurological, renal, hepatic, respiratory conditions or malignancies) or clinically significant screening laboratory value that in the opinion of the investigator may present a safety risk, interfere with study compliance and follow-up, or confound data interpretation throughout the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SCD411
Drug: SCD411
IVT (intravitreal) injection
Active Comparator: Aflibercept
Drug: Aflibercept
IVT injection
Other Names:
  • Eylea®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in BCVA (Best Corrected Visual Acuity)
Time Frame: Baseline to Week 8
Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts
Baseline to Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in BCVA (Best Corrected Visual Acuity)
Time Frame: Baseline to Week 52
Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts
Baseline to Week 52
Percentage of Subjects With Anti-SCD411 Antibodies
Time Frame: Baseline, Weeks 4, 8, 20, 36 and 52
Assessed by blood samples
Baseline, Weeks 4, 8, 20, 36 and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sam Chun Dang Pharm. Co. Ltd.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2020

Primary Completion (Actual)

September 8, 2022

Study Completion (Actual)

September 8, 2022

Study Registration Dates

First Submitted

July 17, 2020

First Submitted That Met QC Criteria

July 17, 2020

First Posted (Actual)

July 21, 2020

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCD411-CP101
  • 2019-004132-37 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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