drugset / Trial / NCT04049266
A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.
RandomizedParallel-groupTriple-blindTreatment
Summary
This study will evaluate the efficacy, safety, durability, and pharmacokinetics of KSI-301 administered at 12, 16 and 20 weeks intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with treatment-naïve neovascular (wet) age-related macular degeneration (nAMD).
Timeline
- Start
- 2019-10-08
- Primary completion
- 2021-11-17
- Completion
- 2022-04-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aflibercept | Protein / enzyme biologic | 2 mg | Intravitreal |
| Subject | Tarcocimab tedromer | Protein / enzyme biologic | 5 mg | Intravitreal |