Phase 2a Study to Evaluate the Efficacy and Safety of SCAI-005 Ophthalmic Solution in Subjects With Neovascular Age-related Macular Degeneration

Subjects who have been informed about the study and have voluntarily agreed to sign to participate in the study will be screened.

Subjects who meet the inclusion/exclusion criteria will be randomized in 2:2:1 ratio into SCAI-005 0.04% and SCAI-005 0.08% and Placebo group.

Efficacy will be assessed at Weeks 4, 8, and 12. Safety and tolerability will be assessed until 12 weeks after randomization.

Inclusion criteria

• 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
• BCVA ETDRS letter score of 80 letters to 25 letters in the study eye as measured by the ETDRS visual acuity chart at screening

Exclusion criteria

• 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
• Subjects with vitreous hemorrhage in the study eye
• History of ocular treatment (except for anti-VEGF IVT therapy), systemic treatment, or surgical intervention for the treatment of neovascular age-related macular degeneration (nAMD) in the study eye
• Administration of intraocular, periocular, or intravitreal (IVT) steroid injection in the study eye within 24 weeks prior to Screening
• Presence of diabetic retinopathy, diabetic macular edema, or other vascular diseases affecting the retina, other than neovascular age-related macular degeneration (nAMD), in either eye
• History of endophthalmitis or idiopathic or autoimmune-related uveitis in either eye
• Subjects with active macular neovascularization identified in the fellow eye at Screening