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

Neovascular Age-related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04480463
• Other study ID #: SCD411-CP101
• Secondary ID: 2019-004132-37
• Status: Completed
• Phase: Phase 3
• Start date: August 13, 2020
• Est. completion date: September 8, 2022

Study information

• Verified date: October 2023
• Source: Sam Chun Dang Pharm. Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 576
• Est. completion date: September 8, 2022
• Est. primary completion date: September 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• SCD411
IVT (intravitreal) injection
• Aflibercept
IVT injection

Locations

Country	Name	City	State
Australia	SCD Research Site	East Melbourne	Victoria
Australia	SCD Research Site	Liverpool	New South Wales
Australia	SCD Research Site	Nedlands	Western Australia
Australia	SCD Research Site	Sydney	New South Wales
Bulgaria	SCD Research Site	Sofia	Sofia-Grad
Bulgaria	SCD Research Site	Sofia	Sofia-Grad
Bulgaria	SCD Research Site	Sofia
Czechia	SCD Research Site	Pardubice	Pardubicky Kraj
Czechia	SCD Research Site	Praha
Hungary	SCD Research Site	Budapest
Hungary	SCD Research Site	Budapest
Hungary	SCD Research Site	Budapest
Hungary	SCD Research Site	Budapest
Hungary	SCD Research Site	Debrecen
Hungary	SCD Research Site	Nyíregyháza
Hungary	SCD Research Site	Pécs
India	SCD Research Site	Bhubaneswar	Orissa
India	SCD Research Site	Hyderabad	Telangana
India	SCD Research Site	Jaipur	Rajasthan
India	SCD Research Site	Kolkata	West Bengal
India	SCD Research Site	Kolkata	West Bengal
India	SCD Research Site	Lucknow	Uttar Pradesh
India	SCD Research Site	Wardha	Maharashtra
Israel	SCD Research Site	H_olon
Israel	SCD Research Site	Haifa
Israel	SCD Research Site	Haifa
Israel	SCD Research Site	Jerusalem
Israel	SCD Research Site	Kfar Saba
Israel	SCD Research Site	Nahariya
Israel	SCD Research Site	Petah tikva
Israel	SCD Research Site	Ramat Gan
Israel	SCD Research Site	Re?ovot
Israel	SCD Research Site	Tel Aviv
Israel	SCD Research Site	Tiberias
Israel	SCD Research Site	Zerifin
Japan	SCD Research Site	Amagasaki	Hyôgo
Japan	SCD Research Site	Chuo Ku	Tokyo
Japan	SCD Research Site	Fukuoka
Japan	SCD Research Site	Fukushima
Japan	SCD Research Site	Hachioji	Tokyo
Japan	SCD Research Site	Kagoshima	Kogosima
Japan	SCD Research Site	Kita
Japan	SCD Research Site	Kobe	Hyogo
Japan	SCD Research Site	Kurume	Hukuoka
Japan	SCD Research Site	Kyoto	Kyôto
Japan	SCD Research Site	Meguro	Tokyo
Japan	SCD Research Site	Nagakute
Japan	SCD Research Site	Nagoya	Aiti
Japan	SCD Research Site	Nakagami	Okinawa
Japan	SCD Research Site	Nerima-ku	Tokyo
Japan	SCD Research Site	Niigata
Japan	SCD Research Site	Nishinomiya	Hyogo
Japan	SCD Research Site	Saga
Japan	SCD Research Site	Sakai
Japan	SCD Research Site	Sakura
Japan	SCD Research Site	Toyama
Japan	SCD Research Site	Ube	Yamaguti
Korea, Republic of	SCD Research Site	Busan
Korea, Republic of	SCD Research Site	Busan
Korea, Republic of	SCD Research Site	Busan
Korea, Republic of	SCD Research Site	Busan
Korea, Republic of	SCD Research Site	Changwon-Si	Gyeongsangnamdo
Korea, Republic of	SCD Research Site	Cheongju-si	Chungcheongbugdo
Korea, Republic of	SCD Research Site	Daegu
Korea, Republic of	SCD Research Site	Daegu
Korea, Republic of	SCD Research Site	Daegu
Korea, Republic of	SCD Research Site	Daejeon
Korea, Republic of	SCD Research Site	Daejeon
Korea, Republic of	SCD Research Site	Guri-si	Gyeonggido
Korea, Republic of	SCD Research Site	Gwangju
Korea, Republic of	SCD Research Site	Incheon
Korea, Republic of	SCD Research Site	Incheon
Korea, Republic of	SCD Research Site	Jinju-si
Korea, Republic of	SCD Research Site	Seoul
Korea, Republic of	SCD Research Site	Seoul
Korea, Republic of	SCD Research Site	Seoul
Korea, Republic of	SCD Research Site	Seoul
Korea, Republic of	SCD Research Site	Seoul
Korea, Republic of	SCD Research Site	Seoul
Korea, Republic of	SCD Research Site	Seoul
Korea, Republic of	SCD Research Site	Seoul
Korea, Republic of	SCD Research Site	Seoul
Korea, Republic of	SCD Research Site	Suwon	Gyeonggido
Latvia	SCD Research Site	Jelgava
Latvia	SCD Research Site	Riga
Latvia	SCD Research Site	Riga
Latvia	SCD Research Site	Riga
Poland	SCD Research Site	Bydgoszcz
Poland	SCD Research Site	Bydgoszcz
Poland	SCD Research Site	Gdansk	Pomorskie
Poland	SCD Research Site	Katowice	Slaskie
Poland	SCD Research Site	Katowice	Slaskie
Poland	SCD Research Site	Lublin
Poland	SCD Research Site	Olsztyn	Warminsko-marzurskie
Poland	SCD Research Site	Rzeszów	Podkarpackie
Poland	SCD Research Site	Walbrzych	Dolnoslaskie
Poland	SCD Research Site	Warszawa	Mazowieckie
Poland	SCD Research Site	Warszawa	Mazowieckie
Poland	SCD Research Site	Warszawa
Poland	SCD Research Site	Wroclaw	Dolnoslaskie
Poland	SCD Research Site	Wroclaw	Dolnoslaskie
Russian Federation	SCD Research Site	Moscow
Russian Federation	SCD Research Site	Moscow
Russian Federation	SCD Research Site	Moscow
Russian Federation	SCD Research Site	Novosibirsk
Slovakia	SCD Research Site	Žilina
Slovakia	SCD Research Site	Bratislava
Slovakia	SCD Research Site	Poprad
Slovakia	SCD Research Site	Trebišov
Spain	SCD Research Site	Barcelona
Spain	SCD Research Site	Barcelona
Spain	SCD Research Site	Bilbao
Spain	SCD Research Site	Bilbao
Spain	SCD Research Site	Majadahonda
Spain	SCD Research Site	Sant Cugat Del Vallès	Barcelona
Spain	SCD Research Site	Valencia
Spain	SCD Research Site	Valladolid
Spain	SCD Research Site	Zaragoza
United States	SCD Research Site	Abilene	Texas
United States	SCD Research Site	Campbell	California
United States	SCD Research Site	Clearwater	Florida
United States	SCD Research Site	Coral Springs	Florida
United States	SCD Research Site	Fort Myers	Florida
United States	SCD Research Site	Lemont	Illinois
United States	SCD Research Site	Liverpool	New York
United States	SCD Research Site	Marietta	Georgia
United States	SCD Research Site	Rapid City	South Dakota
United States	SCD Research Site	Springfield	Oregon
United States	SCD Research Site	Stuart	Florida
United States	SCD Research Site	Willow Park	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sam Chun Dang Pharm. Co. Ltd.

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Czechia,  Hungary,  India,  Israel,  Japan,  Korea, Republic of,  Latvia,  Poland,  Russian Federation,  Slovakia,  Spain, 

Outcome

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

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