This study aims to preliminarily evaluate the efficacy and safety of GB10 intravitreal (IVT) injection for the treatment of patients with neovascular age-related macular degeneration (nAMD). It consists of two parts, single-ascending-dose escalation (SAD) and multiple-ascending-dose escalation (MAD).
In SAD, a single IVT of up to 6 doses will be administered to up to 36 treatment-naïve or previously treated patients with nAMD. If the lowest dose is considered safe without dose-limiting toxicity, escalation will proceed to the next higher dose level. At the end of SAD, the two doses that best balance efficacy and safety will be selected and entered into MAD.
In MAD, a single IVT of 2 doses will be administered to 12 treatment-naïve or previously treated patients with nAMD, who will be enrolled across the low- to high-dose levels.
After GB10 intervention, the participants will undergo tests to evaluate the PK/PD characteristics of GB10 and ocular and non-ocular safety.