Trials / Completed
CompletedNCT04480463
A Study to Comparing SCD411 and Eylea® in Subjects With Wet Age-related Macular Degeneration (AMD)
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 576 (actual)
- Sponsor
- Sam Chun Dang Pharm. Co. Ltd. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SCD411 | IVT (intravitreal) injection |
| DRUG | Aflibercept | IVT injection |
Timeline
- Start date
- 2020-08-13
- Primary completion
- 2022-09-08
- Completion
- 2022-09-08
- First posted
- 2020-07-21
- Last updated
- 2023-10-10
- Results posted
- 2023-10-10
Locations
130 sites across 14 countries: United States, Australia, Bulgaria, Czechia, Hungary, India, Israel, Japan, Latvia, Poland, Russia, Slovakia, South Korea, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04480463. Inclusion in this directory is not an endorsement.