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SamChungDang SCD411-CP101
Research 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
Sponsor: Sam Chung Dang Pharm. Co. Ltd.
Principal Investigator: Robert A. Stoltz, MD, PhD
Description: 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.
Start Date: September 2020
Recruitment: Enrolling
Project Personnel: Leslie Marcus, CCRC; Caitlin Harrison, CCRC; Stephanie Campbell, CRC; Amber Adams, CRC
Location(s): Marietta; 833 Campbell Hill Street, Suite 300, Marietta, GA 30060
Clinical Trial Team
Active Trials
- Amgen 20170542
- Apellis APL2-303 DERBY
- Gemini GEM-NH-001 Clarity 1
- Genentech GR40349 YOSEMITE
- Genentech GR40548 ARCHWAY
- Genentech GR40973 Gallego
- Gyroscope Therapeutics GTSCOPE
- Iveric Bio ISEE2008 GATHER2
- NGM Biopharmaceuticals NGM621-GA-201 CATALINA
- Novartis CRTH258A2303 TALON
- Novartis CRTH258B2305 Kingfisher
- Novartis CRTH258C2302 Raven
- Novo Nordisk NN9535-4352 FOCUS
- Regeneron VGFTe(HD)-DME-1934 PHOTON
- Roche GR40549 PORTAL
- Roche GR40550 PAGODA
- Roche GR40844 LUCERNE
- Roche GR41675 PAVILION
- Roche GR41987 RHONE-X
- SamChungDang SCD411-CP101
- Xbrane XBR1002 XPLORE
Past Trials
- AART C-02-60
- Acucela 4429-202 SEATTLE
- Aerpio AKB-9778-CI-5001 TIME-2b
- Allergan 150998-005 CEDAR
- Allergan 1771-201-008 MAPLE
- Allergan 190342-038 BEACON
- ALLERGAN 206207-012
- AREDS2
- AREDS2 ForeseeHome
- C-09-067 RACE
- DRCR.net Protocol N
- Gemini GEM-NH-002 Clarity 2
- Genentech GR39821
- Graybug GBV-102-002 Altissimo
- HORIZON FVF3426g
- KalVista KVD011-201
- LFG316A2203
- MARINA FVF2598g
- Novartis CSPP100A2244
- Ocriplasmin Research to Better Inform Treatment (ORBIT)
- OPH1002
- OPH1004
- Ophthotech OPH2003
- PDEX
- Regeneron R2176-3-AMD-1417 CAPELLA
- Regeneron R910-3-AMD-1517 ONYX
- Regeneron R910-3-DME-1518 RUBY
- Regeneron VGFTe-OD-1411 PANORAMA
- RIDE FVF4168g
- RISE FVF4170g
- Roche BP 30099 BOULEVARD
- Roche BP29647 AVENUE
- Roche GX29176 CHROMA
- Roche GX30191 OMASPECT
- SAILOR FVF3689g
- SCORE
- SCORE2
- Suprachoroidal Buckling for Retinal Detachment
- Taiwan Liposome Company (TLC) TLC399A2002
- Xcenda C-01-17 ForeseeHome