drugset / Trial / NCT04919096

Study of SCB-420 in Subjects With Neovascular Age-related Macular Degeneration

NCT04919096

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase 1, randomized, double-masked, multicenter, parallel-assignment, pilot study to evaluate the safety, tolerability, initial clinical effectiveness, pharmacokinetics (PK), and immunogenicity of SCB-420 as compared with Eylea (aflibercept), in subjects with Neovascular Age-related Macular Degeneration. A total of 20 subjects with Neovascular Age-related Macular Degeneration will be enrolled across up to 11 sites in 3 countries (Australia, New Zealand, and China). The study will be conducted in 2 parts - Sentinel Safety Cohort and Open Enrolment. Subjects will be administered with 2 mg of SCB-420 or Eylea via intravitreal (IVT) injection every 4 weeks for a total 3 doses.

Timeline

Start
2022-04
Primary completion
2022-09
Completion
2023-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aflibercept Protein / enzyme biologic 2 mg Intravitreal
Subject SCB-420 Unknown 2 mg Intravitreal