Safety and Efficacy of AM712 in Patients with NAMD

The Part 1 of study is a multicenter, open-label, sequentially, multiple ascending-dose study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in subjects with nAMD.

Subjects will be sequentially enrolled into different dose-level cohorts following the traditional "3+3" design until the maximally tolerated dose (MTD) or the maximally administered dose (MAD) has been reached.

The Part 2 of study is a multicenter, open-label, sequential study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in treatment-naïve patients with nAMD.

Inclusion criteria

• Male or female subjects with 50 years of age or older
• Active sub-foveal CNV lesion secondary to nAMD including juxta or extra-foveal lesions that partially affect the fovea
• The area of CNV must occupy at least 50% of total lesion
• Total lesion area ≤ 12 DA
• ETDRS BCVA letter score measured at screening and baseline
• Clear ocular media and adequate pupil dilation to permit good quality photographic imaging in study eye

Exclusion criteria

• Any previous systemic anti-VEGF treatment
• Any systemic treatment or therapy to treat neovascular AMD
• Continuous use of systemic corticosteroids
• Diseases that affect intravenous injection and venous blood sampling
• Presence of CNV due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, or pathologic myopia in study eye
• History or any concurrent ocular condition which, in opinion of investigator, could either confound interpretation of efficacy and safety of IP or require medical or surgical intervention.
• The area of fibrosis occupies ≥ 50% of total lesion area in study eye
• Evidence of myopia degeneration, diagnosis supported by the axial length examination in study eye
• History or any concurrent macular abnormality other than AMD in study eye
• Current vitreous hemorrhage or history of vitreous hemorrhage in study eye
• History of recurrent inflammation in study eye
• History of treatment for nAMD
• Subject having out of range laboratory values defined as:

ALT or AST > 2 x ULN, total bilirubin > 1.5 x ULN Serum creatinine > 1.5 x ULN, BUN > 2 x ULN HbA1c > 7.5% at screening