A Multi-center, Open-Label, Phase 1, Single- and Multiple Ascending Dose Study to Assess Safety and Tolerability of PMC-403 in Subjects With Neovascular Age-related Macular Degeneration (nAMD).
This is a Phase 1 study, first-in-human (FIH), open label study to evaluate the safety, tolerability and identify the maximum tolerated dose (MTD) of PMC-403 and determine the recommended phase 2 dose (RP2D).
∙ To be eligible for study participation, subjects must meet all of the following inclusion criteria.
∙ \* Criteria for the selection of the study eye
∙ If both eyes meet the criteria, the study eye will be selected according to the following criteria:
• The eye with lower (severer) best corrected visual acuity (BCVA) at baseline will be selected as the study eye.
• If both eyes have the same BCVA, the right eye will be selected as the study.
‣ Male and female ≥50 years of age at the time of written informed consent.
⁃ Treatment required, based on the judgment of the investigator, due to insufficient therapeutic efficacy despite ≥ 3 repeated doses of anti-vascular endothelial growth factor (anti-VEGF) intravitreal injection (IVT) for nAMD in the study eye, and the subject's agreement to receive the study drug instead of conventional standard therapy
⁃ \>12 weeks must have elapsed since the last dose of anti-VEGF IVT at the time of screening.
⁃ Active subfoveal or parafoveal choroidal neovascularization (CNV)\* confirmed by fundus fluorescein angiography (FFA), spectral domain-optical coherence tomography (SD-OCT), and IndoCyanine Green (ICG) angiography.
‣ \*Active CNV (confirmed by the central reading center) is defined as the presence of subretinal fluid (SRF) or intraretinal fluid (IRF) in consequence of vascular leakage.
⁃ The size of the entire lesion in the study eye (including blood, atrophy, fibrosis, and neovascularization) must be ≤ 9-disc areas, and the area of CNV in the study eye must account for ≥ 50% of the total area of the lesion, as confirmed by FFA and ICG angiography.
⁃ BCVA measured in the study eye must be between ≥ 23 letters and ≤ 78 letters based on the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart (Snellen visual acuity 20/25 - 20/320).
⁃ Voluntary written informed consent to study participation.