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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04480463




Registration number
NCT04480463
Ethics application status
Date submitted
17/07/2020
Date registered
21/07/2020
Date last updated
10/10/2023

Titles & IDs
Public title
A Study to Comparing SCD411 and Eylea® in Subjects With Wet Age-related Macular Degeneration (AMD)
Scientific 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
Secondary ID [1] 0 0
2019-004132-37
Secondary ID [2] 0 0
SCD411-CP101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wet Age-related Macular Degeneration 0 0
Neovascular Age-related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SCD411
Treatment: Drugs - Aflibercept

Experimental: SCD411 -

Active Comparator: Aflibercept -


Treatment: Drugs: SCD411
IVT (intravitreal) injection

Treatment: Drugs: Aflibercept
IVT injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in BCVA (Best Corrected Visual Acuity)
Timepoint [1] 0 0
Baseline to Week 8
Secondary outcome [1] 0 0
Change From Baseline in BCVA (Best Corrected Visual Acuity)
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [2] 0 0
Percentage of Subjects With Anti-SCD411 Antibodies
Timepoint [2] 0 0
Baseline, Weeks 4, 8, 20, 36 and 52

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/09/2022
Sample size
Target
Accrual to date
Final
576
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
SCD Research Site - Liverpool
Recruitment hospital [2] 0 0
SCD Research Site - Sydney
Recruitment hospital [3] 0 0
SCD Research Site - East Melbourne
Recruitment hospital [4] 0 0
SCD Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Florida
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United States of America
State/province [3] 0 0
Georgia
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United States of America
State/province [4] 0 0
Illinois
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United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
South Dakota
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Sofia-Grad
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Sofia
Country [11] 0 0
Czechia
State/province [11] 0 0
Pardubicky Kraj
Country [12] 0 0
Czechia
State/province [12] 0 0
Praha
Country [13] 0 0
Hungary
State/province [13] 0 0
Budapest
Country [14] 0 0
Hungary
State/province [14] 0 0
Debrecen
Country [15] 0 0
Hungary
State/province [15] 0 0
Nyíregyháza
Country [16] 0 0
Hungary
State/province [16] 0 0
Pécs
Country [17] 0 0
India
State/province [17] 0 0
Maharashtra
Country [18] 0 0
India
State/province [18] 0 0
Orissa
Country [19] 0 0
India
State/province [19] 0 0
Rajasthan
Country [20] 0 0
India
State/province [20] 0 0
Telangana
Country [21] 0 0
India
State/province [21] 0 0
Uttar Pradesh
Country [22] 0 0
India
State/province [22] 0 0
West Bengal
Country [23] 0 0
Israel
State/province [23] 0 0
Haifa
Country [24] 0 0
Israel
State/province [24] 0 0
H_olon
Country [25] 0 0
Israel
State/province [25] 0 0
Jerusalem
Country [26] 0 0
Israel
State/province [26] 0 0
Kfar Saba
Country [27] 0 0
Israel
State/province [27] 0 0
Nahariya
Country [28] 0 0
Israel
State/province [28] 0 0
Petah tikva
Country [29] 0 0
Israel
State/province [29] 0 0
Ramat Gan
Country [30] 0 0
Israel
State/province [30] 0 0
Re?ovot
Country [31] 0 0
Israel
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Tel Aviv
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Israel
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Tiberias
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Israel
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Zerifin
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Japan
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Aiti
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Japan
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Hukuoka
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Japan
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Hyogo
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Japan
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Hyôgo
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Japan
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Kogosima
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Japan
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Kyôto
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Japan
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Okinawa
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Japan
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Tokyo
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Japan
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Yamaguti
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Japan
State/province [43] 0 0
Fukuoka
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Japan
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Fukushima
Country [45] 0 0
Japan
State/province [45] 0 0
Kita
Country [46] 0 0
Japan
State/province [46] 0 0
Nagakute
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Japan
State/province [47] 0 0
Niigata
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Japan
State/province [48] 0 0
Saga
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Japan
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Sakai
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Japan
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Sakura
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Japan
State/province [51] 0 0
Toyama
Country [52] 0 0
Korea, Republic of
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Chungcheongbugdo
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Gyeongsangnamdo
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
State/province [57] 0 0
Daejeon
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Korea, Republic of
State/province [58] 0 0
Gwangju
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Korea, Republic of
State/province [59] 0 0
Incheon
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Korea, Republic of
State/province [60] 0 0
Jinju-si
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Korea, Republic of
State/province [61] 0 0
Seoul
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Latvia
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Jelgava
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Latvia
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Riga
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Poland
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Dolnoslaskie
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Poland
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Mazowieckie
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Poland
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Podkarpackie
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Poland
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Pomorskie
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Poland
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Slaskie
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Poland
State/province [69] 0 0
Warminsko-marzurskie
Country [70] 0 0
Poland
State/province [70] 0 0
Bydgoszcz
Country [71] 0 0
Poland
State/province [71] 0 0
Lublin
Country [72] 0 0
Poland
State/province [72] 0 0
Warszawa
Country [73] 0 0
Russian Federation
State/province [73] 0 0
Moscow
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Russian Federation
State/province [74] 0 0
Novosibirsk
Country [75] 0 0
Slovakia
State/province [75] 0 0
Bratislava
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Slovakia
State/province [76] 0 0
Poprad
Country [77] 0 0
Slovakia
State/province [77] 0 0
Trebišov
Country [78] 0 0
Slovakia
State/province [78] 0 0
Žilina
Country [79] 0 0
Spain
State/province [79] 0 0
Barcelona
Country [80] 0 0
Spain
State/province [80] 0 0
Bilbao
Country [81] 0 0
Spain
State/province [81] 0 0
Majadahonda
Country [82] 0 0
Spain
State/province [82] 0 0
Valencia
Country [83] 0 0
Spain
State/province [83] 0 0
Valladolid
Country [84] 0 0
Spain
State/province [84] 0 0
Zaragoza

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sam Chun Dang Pharm. Co. Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04480463
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Byung Jhip Ha
Address 0 0
Sam Chun Dang Pharm. Co. Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04480463