Age-Related Macular Degeneration Clinical Trial
Official title:
A Phase I/II, Open-label, Dose-escalating, Sequential-cohort Study Assessing the Safety, Tolerability, Pharmacokinetics and Bioactivity of a Single Intravitreal Injection of DE-120 Injectable Solution for the Treatment of Late Stage Exudative Age-related Macular Degeneration
The purpose of this study is to assess the safety, tolerability, bioactivity and pharmacokinetics of three concentrations of DE-120 after a single intravitreal injection in subjects with late stage exudative age-related macular degeneration.
This is an open-label, dose-escalating, sequential-cohort study of DE-120 injectable solution
administered in 9, and up to 12, subjects with late stage exudative age-related macular
degeneration.
Three cohorts of 3 subjects will receive a single intravitreal injection in the study eye.
Subjects in Cohort 1 will receive a single intravitreal injection of Low Dose DE-120
injectable solution in the study eye and will be evaluated through Visit 5 (Month 1). If the
Low Dose is considered to be safe, the next higher dose will be administered to Cohort 2.
The same enrollment and safety review procedures will be followed for Cohort 2 (Medium Dose
DE-120) and Cohort 3 (High Dose DE-120).
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