Trial to Evaluate the Safety and Efficacy of SCAI-005 Ophthalmic solution in Patients with Neovascular Age-related Macular Degeneration.
The purpose of this study is to investigate the efficacy, safety and tolerability of SCAI-005 Ophthalmic solution by dose in patients with neovascular Age-related Macular Degeneration (nAMD).
Adults aged 50 years or older
Subjects who were diagnosed with nAMD in the study eye within 3 years prior to the Screening Visit, who demonstrated a treatment response to at least 3 repeated intravitreal injections of anti-VEGF IVT for nAMD, and whose last anti-VEGF IVT administration was more than 12 weeks prior to the planned date of the first administration of the investigational product.
Active MNV secondary to nAMD with a subfoveal component related to the MNV activity in the study eye as assessed by FA (evidence of leakage) or SD-OCT (presence of fluid) at screening
CST ≤ 450 μm at screening
Subjects with choroidal neovascularization in the study eye due to causes other than nAMD (however, polypoidal choroidal vasculopathy (PCV) can be enrolled)
Presence of scarring, fibrosis, or atrophy involving the fovea in the study eye at Screening
Subjects who have a hemorrhage in the subfoveal region of the study eye and in whom the subretinal hemorrhage area is ≥ 1 optic disk area
History of glaucoma surgery, vitrectomy, submacular surgery, or macular laser treatment (e.g., photodynamic therapy [PDT], laser photocoagulation, etc.) in the study eye