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

NCT04480463 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: SCD411-CP1012019-004132-37
• Study Type: interventional
• Target: 576
• Locations: 14 countries
• Sites: 130

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.

Conditions

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

Keywords

Age-related macular degeneration; AMD; Neovascular; Exudative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change From Baseline in BCVA (Best Corrected Visual Acuity)

  Baseline to Week 52

• Percentage of Subjects With Anti-SCD411 Antibodies

  Baseline, Weeks 4, 8, 20, 36 and 52

Study Arms (2)

SCD411

EXPERIMENTAL

Drug: SCD411

Aflibercept

ACTIVE COMPARATOR

Drug: Aflibercept

Interventions

SCD411 DRUG

IVT (intravitreal) injection

SCD411

Aflibercept DRUG

IVT injection

Also known as: Eylea®

Aflibercept

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sam Chun Dang Pharm. Co. Ltd.: lead

Study Sites (130)

SCD Research Site

Campbell, California, 95008, United States

Location

SCD Research Site

Clearwater, Florida, 33761, United States

Location

SCD Research Site

Coral Springs, Florida, 33067, United States

Location

SCD Research Site

Fort Myers, Florida, 33912, United States

Location

SCD Research Site

Stuart, Florida, 34994, United States

Location

SCD Research Site

Marietta, Georgia, 30060, United States

Location

SCD Research Site

Lemont, Illinois, 60439, United States

Location

SCD Research Site

Liverpool, New York, 13088, United States

Location

SCD Research Site

Springfield, Oregon, 97477, United States

Location

SCD Research Site

Rapid City, South Dakota, 57701, United States

Location

SCD Research Site

Abilene, Texas, 79606, United States

Location

SCD Research Site

Willow Park, Texas, 76087, United States

Location

SCD Research Site

Liverpool, New South Wales, 2170, Australia

Location

SCD Research Site

Sydney, New South Wales, 2000, Australia

Location

SCD Research Site

East Melbourne, Victoria, 3002, Australia

Location

SCD Research Site

Nedlands, Western Australia, 6009, Australia

Location

SCD Research Site

Sofia, Sofia-Grad, 1431, Bulgaria

Location

SCD Research Site

Sofia, Sofia-Grad, 1784, Bulgaria

Location

SCD Research Site

Sofia, 1618, Bulgaria

Location

SCD Research Site

Pardubice, Pardubický kraj, 530 02, Czechia

Location

SCD Research Site

Prague, 128 08, Czechia

Location

SCD Research Site

Budapest, 1062, Hungary

Location

SCD Research Site

Budapest, 1085, Hungary

Location

SCD Research Site

Budapest, 1133, Hungary

Location

SCD Research Site

Budapest, 1204, Hungary

Location

SCD Research Site

Debrecen, 4032, Hungary

Location

SCD Research Site

Nyíregyháza, 4400, Hungary

Location

SCD Research Site

Pécs, 7621, Hungary

Location

SCD Research Site

Wardha, Maharashtra, 442001, India

Location

SCD Research Site

Bhubaneswar, Odisha, 751024, India

Location

SCD Research Site

Jaipur, Rajasthan, 302015, India

Location

SCD Research Site

Hyderabad, Telangana, 500018, India

Location

SCD Research Site

Lucknow, Uttar Pradesh, 226001, India

Location

SCD Research Site

Kolkata, West Bengal, 700020, India

Location

SCD Research Site

Kolkata, West Bengal, 700073, India

Location

SCD Research Site

Haifa, 31096, Israel

Location

SCD Research Site

Haifa, 34362, Israel

Location

SCD Research Site

Holon, 58100, Israel

Location

SCD Research Site

Jerusalem, 91120, Israel

Location

SCD Research Site

Kfar Saba, 44281, Israel

Location

SCD Research Site

Nahariya, 22100, Israel

Location

SCD Research Site

Petah Tikva, 49100, Israel

Location

SCD Research Site

Ramat Gan, 52621, Israel

Location

SCD Research Site

Rehovot, 76100, Israel

Location

SCD Research Site

Tel Aviv, 64239, Israel

Location

SCD Research Site

Tiberias, 15208, Israel

Location

SCD Research Site

Ẕerifin, 70300, Israel

Location

SCD Research Site

Nagoya, Aiti, 457-8510, Japan

Location

SCD Research Site

Kurume, Hukuoka, 830-0011, Japan

Location

SCD Research Site

Amagasaki, Hyôgo, 660-8550, Japan

Location

SCD Research Site

Kobe, Hyōgo, 650-0047, Japan

Location

SCD Research Site

Nishinomiya, Hyōgo, 663-8501, Japan

Location

SCD Research Site

Kagoshima, Kagoshima-ken, 890-8520, Japan

Location

SCD Research Site

Kyoto, Kyôto, 607-8062, Japan

Location

SCD Research Site

Nakagami, Okinawa, 903-0215, Japan

Location

SCD Research Site

Chuo Ku, Tokyo, 104-8560, Japan

Location

SCD Research Site

Hachiōji, Tokyo, 193-0998, Japan

Location

SCD Research Site

Meguro City, Tokyo, 152-8902, Japan

Location

SCD Research Site

Nerima-ku, Tokyo, 177-8521, Japan

Location

SCD Research Site

Ube, Yamaguchi, 755-8505, Japan

Location

SCD Research Site

Fukuoka, 812-0011, Japan

Location

SCD Research Site

Fukushima, 960-1295, Japan

Location

SCD Research Site

Kita-ku, 761-0793, Japan

Location

SCD Research Site

Nagakute, 480-1195, Japan

Location

SCD Research Site

Niigata, 951-8520, Japan

Location

SCD Research Site

Saga, 849-8501, Japan

Location

SCD Research Site

Sakai, 593-8304, Japan

Location

SCD Research Site

Sakura, 285-8741, Japan

Location

SCD Research Site

Toyama, 930-0194, Japan

Location

SCD Research Site

Jelgava, LV-3001, Latvia

Location

SCD Research Site

Riga, LV-1002, Latvia

Location

SCD Research Site

Riga, LV-1006, Latvia

Location

SCD Research Site

Riga, LV-1009, Latvia

Location

SCD Research Site

Wałbrzych, Lower Silesian Voivodeship, 58-309, Poland

Location

SCD Research Site

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

Location

SCD Research Site

Wroclaw, Lower Silesian Voivodeship, 50-981, Poland

Location

SCD Research Site

Warsaw, Masovian Voivodeship, 01-258, Poland

Location

SCD Research Site

Warsaw, Masovian Voivodeship, 01-364, Poland

Location

SCD Research Site

Rzeszów, Podkarpackie Voivodeship, 35-017, Poland

Location

SCD Research Site

Gdansk, Pomeranian Voivodeship, 80-809, Poland

Location

SCD Research Site

Katowice, Silesian Voivodeship, 40-514, Poland

Location

SCD Research Site

Katowice, Silesian Voivodeship, 40-594, Poland

Location

SCD Research Site

Olsztyn, Warminsko-marzurskie, 10-424, Poland

Location

SCD Research Site

Bydgoszcz, 85-631, Poland

Location

SCD Research Site

Bydgoszcz, 85-870, Poland

Location

SCD Research Site

Lublin, 20-079, Poland

Location

SCD Research Site

Warsaw, 00-215, Poland

Location

SCD Research Site

Moscow, 101750, Russia

Location

SCD Research Site

Moscow, 127473, Russia

Location

SCD Research Site

Moscow, 127486, Russia

Location

SCD Research Site

Novosibirsk, 630087, Russia

Location

SCD Research Site

Bratislava, 826 06, Slovakia

Location

SCD Research Site

Poprad, 058 45, Slovakia

Location

SCD Research Site

Trebišov, 075 01, Slovakia

Location

SCD Research Site

Žilina, 012 07, Slovakia

Location

SCD Research Site

Guri-si, Gyeonggido, 11923, South Korea

Location

SCD Research Site

Suwon, Gyeonggido, 16499, South Korea

Location

SCD Research Site

Changwon-Si, Gyeongsangnam-do, 51472, South Korea

Location

SCD Research Site

Cheongju-si, North Chungcheong, 28644, South Korea

Location

SCD Research Site

Busan, 48108, South Korea

Location

SCD Research Site

Busan, 49201, South Korea

Location

SCD Research Site

Busan, 49241, South Korea

Location

SCD Research Site

Busan, 49267, South Korea

Location

SCD Research Site

Daegu, 41944, South Korea

Location

SCD Research Site

Daegu, 42415, South Korea

Location

SCD Research Site

Daegu, 42601, South Korea

Location

SCD Research Site

Daejeon, 35015, South Korea

Location

SCD Research Site

Daejeon, 35365, South Korea

Location

SCD Research Site

Gwangju, 61469, South Korea

Location

SCD Research Site

Incheon, 21565, South Korea

Location

SCD Research Site

Incheon, 22332, South Korea

Location

SCD Research Site

Jinju, 52727, South Korea

Location

SCD Research Site

Seoul, 02447, South Korea

Location

SCD Research Site

Seoul, 02841, South Korea

Location

SCD Research Site

Seoul, 03080, South Korea

Location

SCD Research Site

Seoul, 05355, South Korea

Location

SCD Research Site

Seoul, 05505, South Korea

Location

SCD Research Site

Seoul, 06198, South Korea

Location

SCD Research Site

Seoul, 06351, South Korea

Location

SCD Research Site

Seoul, 07441, South Korea

Location

SCD Research Site

Seoul, 7061, South Korea

Location

SCD Research Site

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

SCD Research Site

Barcelona, 08022, Spain

Location

SCD Research Site

Barcelona, 08025, Spain

Location

SCD Research Site

Bilbao, 48006, Spain

Location

SCD Research Site

Bilbao, 48010, Spain

Location

SCD Research Site

Majadahonda, 28222, Spain

Location

SCD Research Site

Valencia, 46014, Spain

Location

SCD Research Site

Valladolid, 47012, Spain

Location

SCD Research Site

Zaragoza, 50009, Spain

Location

Related Links

• FDA Safety Alerts and Recalls
• FDA Recalls, Market Withdrawals, and Safety Alerts

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Byung Jhip Ha, Director of Bio Research Center
• Organization: SamChunDang Pharm. Co. Ltd.

scd411clinical@scd.co.kr

+82-31-869-7327

Study Officials

• Byung Jhip Ha

  Sam Chun Dang Pharm. Co. Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: July 21, 2020
• Study Start: August 13, 2020
• Primary Completion: September 8, 2022
• Study Completion: September 8, 2022
• Last Updated: October 10, 2023
• Results First Posted: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (9); JP (22); IL (12); PL (14); LA (4); RU (4); HU (7); US (12); BU (3); AU (4); CZ (2); IN (7); SL (4); KR (26)