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
Overview
- Phase
- Phase 3
- Intervention
- SCD411
- Conditions
- Wet Age-related Macular Degeneration
- Sponsor
- Sam Chun Dang Pharm. Co. Ltd.
- Enrollment
- 576
- Locations
- 1
- Primary Endpoint
- Change From Baseline in BCVA (Best Corrected Visual Acuity)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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/SCD
- •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.
Arms & Interventions
SCD411
Intervention: SCD411
Aflibercept
Intervention: Aflibercept
Outcomes
Primary Outcomes
Change From Baseline in BCVA (Best Corrected Visual Acuity)
Time Frame: Baseline to Week 8
Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts
Secondary Outcomes
- 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)