Age-related Macular Degeneration (AMD) Clinical Trial
Official title:
An Open-label Single Ascending Dose and Randomized Double-Masked, Ranibizumab Controlled, Safety, Tolerability, and Efficacy Study of Intravitreal LMG324 in Subjects With Neovascular Age-Related Macular Degeneration
The purpose of this first-in-human study is to evaluate the safety and tolerability of single ascending doses of LMG324 to determine the maximum tolerated dose (MTD) in neovascular age-related macular degeneration (nvAMD) subjects. Enrollment will be expanded at a safe and tolerated dose in treatment naïve nvAMD subjects to compare a single intravitreal (IVT) dose of LMG324 to ranibizumab 0.5 mg administered every 4 weeks for change from baseline in best-corrected visual acuity (BCVA) at Week 12 (Day 85).
The study will start with a single dose ascending (SAD) phase. LMG324 will be administered on
Day 1 with no further treatment until implementation of standard of care (SoC) therapy. SoC
therapy is ranibizumab 0.5 mg administered per label. Dose groups will be implemented
sequentially to allow for safety review between the current and subsequent dose group. All
treatments will be open-label, including ranibizumab used as SoC therapy.
In the enrollment expansion phase, subjects randomized to LMG324 arm will receive a single
LMG324 IVT injection on Day 1 followed by sham (fake) IVT injections until implementation of
SoC therapy. After implementation, SoC therapy will be applied monthly with sham injections
applied at the interim planned visits. The enrollment expansion phase may start at a selected
dose level whilst the dose escalation phase is still ongoing.
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