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

NCT ID: NCT04480463

Last Updated: 2023-10-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

576 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-13

Study Completion Date

2022-09-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Wet Age-related Macular Degeneration Neovascular Age-related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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SCD411

Group Type EXPERIMENTAL

SCD411

Intervention Type DRUG

IVT (intravitreal) injection

Aflibercept

Group Type ACTIVE_COMPARATOR

Aflibercept

Intervention Type DRUG

IVT injection

Interventions

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SCD411

IVT (intravitreal) injection

Intervention Type DRUG

Aflibercept

IVT injection

Intervention Type DRUG

Other Intervention Names

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Eylea®

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sam Chun Dang Pharm. Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Byung Jhip Ha

Role: STUDY_DIRECTOR

Sam Chun Dang Pharm. Co. Ltd.

Locations

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SCD Research Site

Žilina, , Slovakia

Site Status

SCD Research Site

Guri-si, Gyeonggido, South Korea

Site Status

SCD Research Site

Suwon, Gyeonggido, South Korea

Site Status

SCD Research Site

Changwon-Si, Gyeongsangnam-do, South Korea

Site Status

SCD Research Site

Novosibirsk, , Russia

Site Status

SCD Research Site

Bratislava, , Slovakia

Site Status

SCD Research Site

Campbell, California, United States

Site Status

SCD Research Site

Clearwater, Florida, United States

Site Status

SCD Research Site

Coral Springs, Florida, United States

Site Status

SCD Research Site

Fort Myers, Florida, United States

Site Status

SCD Research Site

Stuart, Florida, United States

Site Status

SCD Research Site

Marietta, Georgia, United States

Site Status

SCD Research Site

Lemont, Illinois, United States

Site Status

SCD Research Site

Liverpool, New York, United States

Site Status

SCD Research Site

Springfield, Oregon, United States

Site Status

SCD Research Site

Rapid City, South Dakota, United States

Site Status

SCD Research Site

Abilene, Texas, United States

Site Status

SCD Research Site

Willow Park, Texas, United States

Site Status

SCD Research Site

Liverpool, New South Wales, Australia

Site Status

SCD Research Site

Sydney, New South Wales, Australia

Site Status

SCD Research Site

East Melbourne, Victoria, Australia

Site Status

SCD Research Site

Poprad, , Slovakia

Site Status

SCD Research Site

Trebišov, , Slovakia

Site Status

SCD Research Site

Nedlands, Western Australia, Australia

Site Status

SCD Research Site

Sofia, Sofia-Grad, Bulgaria

Site Status

SCD Research Site

Sofia, Sofia-Grad, Bulgaria

Site Status

SCD Research Site

Sofia, , Bulgaria

Site Status

SCD Research Site

Pardubice, Pardubický kraj, Czechia

Site Status

SCD Research Site

Prague, , Czechia

Site Status

SCD Research Site

Budapest, , Hungary

Site Status

SCD Research Site

Budapest, , Hungary

Site Status

SCD Research Site

Budapest, , Hungary

Site Status

SCD Research Site

Budapest, , Hungary

Site Status

SCD Research Site

Debrecen, , Hungary

Site Status

SCD Research Site

Nyíregyháza, , Hungary

Site Status

SCD Research Site

Pécs, , Hungary

Site Status

SCD Research Site

Wardha, Maharashtra, India

Site Status

SCD Research Site

Bhubaneswar, Odisha, India

Site Status

SCD Research Site

Jaipur, Rajasthan, India

Site Status

SCD Research Site

Hyderabad, Telangana, India

Site Status

SCD Research Site

Lucknow, Uttar Pradesh, India

Site Status

SCD Research Site

Kolkata, West Bengal, India

Site Status

SCD Research Site

Kolkata, West Bengal, India

Site Status

SCD Research Site

Haifa, , Israel

Site Status

SCD Research Site

Haifa, , Israel

Site Status

SCD Research Site

Holon, , Israel

Site Status

SCD Research Site

Jerusalem, , Israel

Site Status

SCD Research Site

Kfar Saba, , Israel

Site Status

SCD Research Site

Nahariya, , Israel

Site Status

SCD Research Site

Petah Tikva, , Israel

Site Status

SCD Research Site

Ramat Gan, , Israel

Site Status

SCD Research Site

Rehovot, , Israel

Site Status

SCD Research Site

Tel Aviv, , Israel

Site Status

SCD Research Site

Tiberias, , Israel

Site Status

SCD Research Site

Ẕerifin, , Israel

Site Status

SCD Research Site

Nagoya, Aiti, Japan

Site Status

SCD Research Site

Kurume, Hukuoka, Japan

Site Status

SCD Research Site

Amagasaki, Hyôgo, Japan

Site Status

SCD Research Site

Kobe, Hyōgo, Japan

Site Status

SCD Research Site

Nishinomiya, Hyōgo, Japan

Site Status

SCD Research Site

Kagoshima, Kagoshima-ken, Japan

Site Status

SCD Research Site

Kyoto, Kyôto, Japan

Site Status

SCD Research Site

Nakagami, Okinawa, Japan

Site Status

SCD Research Site

Chuo Ku, Tokyo, Japan

Site Status

SCD Research Site

Hachiōji, Tokyo, Japan

Site Status

SCD Research Site

Meguro City, Tokyo, Japan

Site Status

SCD Research Site

Nerima-ku, Tokyo, Japan

Site Status

SCD Research Site

Ube, Yamaguchi, Japan

Site Status

SCD Research Site

Fukuoka, , Japan

Site Status

SCD Research Site

Fukushima, , Japan

Site Status

SCD Research Site

Kita-ku, , Japan

Site Status

SCD Research Site

Nagakute, , Japan

Site Status

SCD Research Site

Niigata, , Japan

Site Status

SCD Research Site

Saga, , Japan

Site Status

SCD Research Site

Sakai, , Japan

Site Status

SCD Research Site

Sakura, , Japan

Site Status

SCD Research Site

Toyama, , Japan

Site Status

SCD Research Site

Jelgava, , Latvia

Site Status

SCD Research Site

Riga, , Latvia

Site Status

SCD Research Site

Riga, , Latvia

Site Status

SCD Research Site

Riga, , Latvia

Site Status

SCD Research Site

Wałbrzych, Lower Silesian Voivodeship, Poland

Site Status

SCD Research Site

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

SCD Research Site

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

SCD Research Site

Warsaw, Masovian Voivodeship, Poland

Site Status

SCD Research Site

Warsaw, Masovian Voivodeship, Poland

Site Status

SCD Research Site

Rzeszów, Podkarpackie Voivodeship, Poland

Site Status

SCD Research Site

Gdansk, Pomeranian Voivodeship, Poland

Site Status

SCD Research Site

Katowice, Silesian Voivodeship, Poland

Site Status

SCD Research Site

Katowice, Silesian Voivodeship, Poland

Site Status

SCD Research Site

Olsztyn, Warminsko-marzurskie, Poland

Site Status

SCD Research Site

Bydgoszcz, , Poland

Site Status

SCD Research Site

Bydgoszcz, , Poland

Site Status

SCD Research Site

Lublin, , Poland

Site Status

SCD Research Site

Warsaw, , Poland

Site Status

SCD Research Site

Moscow, , Russia

Site Status

SCD Research Site

Moscow, , Russia

Site Status

SCD Research Site

Moscow, , Russia

Site Status

SCD Research Site

Cheongju-si, North Chungcheong, South Korea

Site Status

SCD Research Site

Busan, , South Korea

Site Status

SCD Research Site

Busan, , South Korea

Site Status

SCD Research Site

Busan, , South Korea

Site Status

SCD Research Site

Busan, , South Korea

Site Status

SCD Research Site

Daegu, , South Korea

Site Status

SCD Research Site

Daegu, , South Korea

Site Status

SCD Research Site

Daegu, , South Korea

Site Status

SCD Research Site

Daejeon, , South Korea

Site Status

SCD Research Site

Daejeon, , South Korea

Site Status

SCD Research Site

Gwangju, , South Korea

Site Status

SCD Research Site

Incheon, , South Korea

Site Status

SCD Research Site

Incheon, , South Korea

Site Status

SCD Research Site

Jinju, , South Korea

Site Status

SCD Research Site

Seoul, , South Korea

Site Status

SCD Research Site

Seoul, , South Korea

Site Status

SCD Research Site

Seoul, , South Korea

Site Status

SCD Research Site

Seoul, , South Korea

Site Status

SCD Research Site

Seoul, , South Korea

Site Status

SCD Research Site

Seoul, , South Korea

Site Status

SCD Research Site

Seoul, , South Korea

Site Status

SCD Research Site

Seoul, , South Korea

Site Status

SCD Research Site

Seoul, , South Korea

Site Status

SCD Research Site

Sant Cugat del Vallès, Barcelona, Spain

Site Status

SCD Research Site

Barcelona, , Spain

Site Status

SCD Research Site

Barcelona, , Spain

Site Status

SCD Research Site

Bilbao, , Spain

Site Status

SCD Research Site

Bilbao, , Spain

Site Status

SCD Research Site

Majadahonda, , Spain

Site Status

SCD Research Site

Valencia, , Spain

Site Status

SCD Research Site

Valladolid, , Spain

Site Status

SCD Research Site

Zaragoza, , Spain

Site Status

Countries

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United States Australia Bulgaria Czechia Hungary India Israel Japan Latvia Poland Russia Slovakia South Korea Spain

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

FDA Recalls, Market Withdrawals, and Safety Alerts

Other Identifiers

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2019-004132-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SCD411-CP101

Identifier Type: -

Identifier Source: org_study_id

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