SCD411
DrugIVT (intravitreal) injection
NCT Number: NCT04480463
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.
Looking for future studies?
Notify Me50 year and older
All sexes
Interventional
Phase 3
SCD Research Site, Liverpool, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IVT (intravitreal) injection
IVT injection
Other names: Eylea®
Time frame: Baseline to Week 8
Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts
Time frame: Baseline to Week 52
Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts
Time frame: Baseline, Weeks 4, 8, 20, 36 and 52
Assessed by blood samples
Sam Chun Dang Pharm. Co. Ltd.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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