A Multicenter, Open-label, Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral HX9428 Tablets in Subjects With Wet Age-related Macular Degeneration (wAMD)
This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of Oral HX9428 tablets in patients with wet age-related macular degeneration(wAMD)
• Participants must meet the following criteria for study entry:
‣ Age ≥50 years and ≤80 years (Phase I), Age ≥50 years and ≤85 years (Phase II) at the time of signing informed consent, male or female;
⁃ Active choroidal neovascularization (CNV) secondary to AMD, as evidenced on fluorescein fundus angiography (FFA) and optical coherence tomography (OCT) (Active CNV is defined as the presence of subretinal or intraretinal fluid or leakage); A total lesion size of \<12 disc areas on FFA ;
⁃ Treatment-naive , or previous anti-VEGF treatment that was effective and discontinued for more than 3 months, with OCT evidence of subretinal fluid or cystoid macular edema;
⁃ ETDRS BCVA 19 to 78 letters in the study eyes( corresponding to a Snellen equivalent of approximately 20/32 to 20/400) ;
⁃ Other protocol-specified inclusion criteria may apply