Clinical trial NCT04480463: A Study to Comparing SCD411 and Eylea® in Subjects With Wet Age-related Macular Degeneration (AMD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Wet Age-related Macular Degeneration
Neovascular Age-related Macular Degeneration
Keywords: Age-related macular degeneration
AMD
Neovascular
Exudative
Lead sponsor: Sam Chun Dang Pharm. Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-07-21
Enrollment: 576
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in BCVA (Best Corrected Visual Acuity)
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change From Baseline in BCVA (Best Corrected Visual Acuity)
timeFrame: Baseline to Week 52
measure: Percentage of Subjects With Anti-SCD411 Antibodies
timeFrame: Baseline, Weeks 4, 8, 20, 36 and 52
Other outcomes:
Locations:
city: Campbell
country: United States
facility: SCD Research Site
state: California
city: Clearwater
country: United States
facility: SCD Research Site
state: Florida
city: Coral Springs
country: United States
facility: SCD Research Site
state: Florida
city: Fort Myers
country: United States
facility: SCD Research Site
state: Florida
city: Stuart
country: United States
facility: SCD Research Site
state: Florida
city: Marietta
country: United States
facility: SCD Research Site
state: Georgia
city: Lemont
country: United States
facility: SCD Research Site
state: Illinois
city: Liverpool
country: United States
facility: SCD Research Site
state: New York
city: Springfield
country: United States
facility: SCD Research Site
state: Oregon
city: Rapid City
country: United States
facility: SCD Research Site
state: South Dakota
city: Abilene
country: United States
facility: SCD Research Site
state: Texas
city: Willow Park
country: United States
facility: SCD Research Site
state: Texas
city: Liverpool
country: Australia
facility: SCD Research Site
state: New South Wales
city: Sydney
country: Australia
facility: SCD Research Site
state: New South Wales
city: East Melbourne
country: Australia
facility: SCD Research Site
state: Victoria
city: Nedlands
country: Australia
facility: SCD Research Site
state: Western Australia
city: Sofia
country: Bulgaria
facility: SCD Research Site
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: SCD Research Site
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: SCD Research Site
city: Pardubice
country: Czechia
facility: SCD Research Site
state: Pardubicky Kraj
city: Praha
country: Czechia
facility: SCD Research Site
city: Budapest
country: Hungary
facility: SCD Research Site
city: Budapest
country: Hungary
facility: SCD Research Site
city: Budapest
country: Hungary
facility: SCD Research Site
city: Budapest
country: Hungary
facility: SCD Research Site
city: Debrecen
country: Hungary
facility: SCD Research Site
city: Nyíregyháza
country: Hungary
facility: SCD Research Site
city: Pécs
country: Hungary
facility: SCD Research Site
city: Wardha
country: India
facility: SCD Research Site
state: Maharashtra
city: Bhubaneswar
country: India
facility: SCD Research Site
state: Orissa
city: Jaipur
country: India
facility: SCD Research Site
state: Rajasthan
city: Hyderabad
country: India
facility: SCD Research Site
state: Telangana
city: Lucknow
country: India
facility: SCD Research Site
state: Uttar Pradesh
city: Kolkata
country: India
facility: SCD Research Site
state: West Bengal
city: Kolkata
country: India
facility: SCD Research Site
state: West Bengal
city: Haifa
country: Israel
facility: SCD Research Site
city: Haifa
country: Israel
facility: SCD Research Site
city: H̱olon
country: Israel
facility: SCD Research Site
city: Jerusalem
country: Israel
facility: SCD Research Site
city: Kfar Saba
country: Israel
facility: SCD Research Site
city: Nahariya
country: Israel
facility: SCD Research Site
city: Petah tikva
country: Israel
facility: SCD Research Site
city: Ramat Gan
country: Israel
facility: SCD Research Site
city: Reẖovot
country: Israel
facility: SCD Research Site
city: Tel Aviv
country: Israel
facility: SCD Research Site
city: Tiberias
country: Israel
facility: SCD Research Site
city: Zerifin
country: Israel
facility: SCD Research Site
city: Nagoya
country: Japan
facility: SCD Research Site
state: Aiti
city: Kurume
country: Japan
facility: SCD Research Site
state: Hukuoka
city: Kobe
country: Japan
facility: SCD Research Site
state: Hyogo
city: Nishinomiya
country: Japan
facility: SCD Research Site
state: Hyogo
city: Amagasaki
country: Japan
facility: SCD Research Site
state: Hyôgo
city: Kagoshima
country: Japan
facility: SCD Research Site
state: Kogosima
city: Kyoto
country: Japan
facility: SCD Research Site
state: Kyôto
city: Nakagami
country: Japan
facility: SCD Research Site
state: Okinawa
city: Chuo Ku
country: Japan
facility: SCD Research Site
state: Tokyo
city: Hachiōji
country: Japan
facility: SCD Research Site
state: Tokyo
city: Meguro
country: Japan
facility: SCD Research Site
state: Tokyo
city: Nerima-ku
country: Japan
facility: SCD Research Site
state: Tokyo
city: Ube
country: Japan
facility: SCD Research Site
state: Yamaguti
city: Fukuoka
country: Japan
facility: SCD Research Site
city: Fukushima
country: Japan
facility: SCD Research Site
city: Kita
country: Japan
facility: SCD Research Site
city: Nagakute
country: Japan
facility: SCD Research Site
city: Niigata
country: Japan
facility: SCD Research Site
city: Saga
country: Japan
facility: SCD Research Site
city: Sakai
country: Japan
facility: SCD Research Site
city: Sakura
country: Japan
facility: SCD Research Site
city: Toyama
country: Japan
facility: SCD Research Site
city: Cheongju-si
country: Korea, Republic of
facility: SCD Research Site
state: Chungcheongbugdo
city: Guri-si
country: Korea, Republic of
facility: SCD Research Site
state: Gyeonggido
city: Suwon
country: Korea, Republic of
facility: SCD Research Site
state: Gyeonggido
city: Changwon-Si
country: Korea, Republic of
facility: SCD Research Site
state: Gyeongsangnamdo
city: Busan
country: Korea, Republic of
facility: SCD Research Site
city: Busan
country: Korea, Republic of
facility: SCD Research Site
city: Busan
country: Korea, Republic of
facility: SCD Research Site
city: Busan
country: Korea, Republic of
facility: SCD Research Site
city: Daegu
country: Korea, Republic of
facility: SCD Research Site
city: Daegu
country: Korea, Republic of
facility: SCD Research Site
city: Daegu
country: Korea, Republic of
facility: SCD Research Site
city: Daejeon
country: Korea, Republic of
facility: SCD Research Site
city: Daejeon
country: Korea, Republic of
facility: SCD Research Site
city: Gwangju
country: Korea, Republic of
facility: SCD Research Site
city: Incheon
country: Korea, Republic of
facility: SCD Research Site
city: Incheon
country: Korea, Republic of
facility: SCD Research Site
city: Jinju-si
country: Korea, Republic of
facility: SCD Research Site
city: Seoul
country: Korea, Republic of
facility: SCD Research Site
city: Seoul
country: Korea, Republic of
facility: SCD Research Site
city: Seoul
country: Korea, Republic of
facility: SCD Research Site
city: Seoul
country: Korea, Republic of
facility: SCD Research Site
city: Seoul
country: Korea, Republic of
facility: SCD Research Site
city: Seoul
country: Korea, Republic of
facility: SCD Research Site
city: Seoul
country: Korea, Republic of
facility: SCD Research Site
city: Seoul
country: Korea, Republic of
facility: SCD Research Site
city: Seoul
country: Korea, Republic of
facility: SCD Research Site
city: Jelgava
country: Latvia
facility: SCD Research Site
city: Riga
country: Latvia
facility: SCD Research Site
city: Riga
country: Latvia
facility: SCD Research Site
city: Riga
country: Latvia
facility: SCD Research Site
city: Wałbrzych
country: Poland
facility: SCD Research Site
state: Dolnoslaskie
city: Wrocław
country: Poland
facility: SCD Research Site
state: Dolnoslaskie
city: Wrocław
country: Poland
facility: SCD Research Site
state: Dolnoslaskie
city: Warszawa
country: Poland
facility: SCD Research Site
state: Mazowieckie
city: Warszawa
country: Poland
facility: SCD Research Site
state: Mazowieckie
city: Rzeszów
country: Poland
facility: SCD Research Site
state: Podkarpackie
city: Gdańsk
country: Poland
facility: SCD Research Site
state: Pomorskie
city: Katowice
country: Poland
facility: SCD Research Site
state: Slaskie
city: Katowice
country: Poland
facility: SCD Research Site
state: Slaskie
city: Olsztyn
country: Poland
facility: SCD Research Site
state: Warminsko-marzurskie
city: Bydgoszcz
country: Poland
facility: SCD Research Site
city: Bydgoszcz
country: Poland
facility: SCD Research Site
city: Lublin
country: Poland
facility: SCD Research Site
city: Warszawa
country: Poland
facility: SCD Research Site
city: Moscow
country: Russian Federation
facility: SCD Research Site
city: Moscow
country: Russian Federation
facility: SCD Research Site
city: Moscow
country: Russian Federation
facility: SCD Research Site
city: Novosibirsk
country: Russian Federation
facility: SCD Research Site
city: Bratislava
country: Slovakia
facility: SCD Research Site
city: Poprad
country: Slovakia
facility: SCD Research Site
city: Trebišov
country: Slovakia
facility: SCD Research Site
city: Žilina
country: Slovakia
facility: SCD Research Site
city: Sant Cugat Del Vallès
country: Spain
facility: SCD Research Site
state: Barcelona
city: Barcelona
country: Spain
facility: SCD Research Site
city: Barcelona
country: Spain
facility: SCD Research Site
city: Bilbao
country: Spain
facility: SCD Research Site
city: Bilbao
country: Spain
facility: SCD Research Site
city: Majadahonda
country: Spain
facility: SCD Research Site
city: Valencia
country: Spain
facility: SCD Research Site
city: Valladolid
country: Spain
facility: SCD Research Site
city: Zaragoza
country: Spain
facility: SCD Research Site
Study officials:
affiliation: Sam Chun Dang Pharm. Co. Ltd.
name: Byung Jhip Ha
role: STUDY_DIRECTOR
References: