Safety and Efficacy Evaluation of SMZ1 With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration Without Polypoidal Choroidal Vasculopathy

Inclusion Criteria:

• 50 years of age or older

• A study eye satisfying all of the following criteria after screening

  ① Active* submacular choroidal neovascularization due to nAMD confirmed by fluorescein angiography (FAG) and optical coherence tomography (OCT)

  *Fluorescence leakage confirmed via FAG and intraretinal or subretinal fluid confirmed via OCT

  ② Absence of active polypoidal lesions due to polypoidal choroidal vasculopathy (PCV) confirmed by indocyanine green angiography (ICGA)

• A study eye with fibrosis covering less than 50% of the total lesion area
• A study eye with ETDRS best corrected visual acuity (BCVA) score range of 73-24 at a distance of 4m (equivalent to 20/40-20/320 of Snellen)
• A study eye with a neovascular lesion area of less than 12 optic-disk areas (For an optic nerve head diameter set to 1.8mm, the corresponding optic-disk area is 2.45mm2)
• Provided written informed consent voluntarily after receiving a full explanation of the clinical trial.

Exclusion Criteria:

• History of ocular treatment, systemic therapies, or surgical procedures, such as photodynamic therapy (PDT) and laser photocoagulation, for the treatment of wet nAMD (supplements and vitamins excluded)
• History of anti-VEGF treatment (e.g., ranibizumab, bevacizumab, aflibercept 2mg, or biosimilars) or combination therapy in the study eye for the treatment of wet nAMD
• A study eye with scarring or fibrosis covering more than 50% of the total lesion area
• A study eye with vitreous hemorrhage occurring within 1 month prior to the Screening Visit
• A study eye with intraocular pressure (IOP) ≥ 25mmHg, including glaucoma with IOP ≥ 25mmHg despite medical treatment
• A study eye with a total lesion area (including vessels, scar tissue, and neovascularization) greater than 12 optic-disk areas (>30.5mm2), as measured by FAG