Clinical Study of PAL-222 Targeting Patients With Myopic Chorioretinal Atrophy (PAMyCA)

Inclusion criteria

• Patients aged 20 years or older at the time of consent acquisition
• Patients with binocular intensity myopia (myopia of -6.0 diopter (D) or more) or patients with axial length (26 mm) or more equivalent to -6.0 D
• Corrected characters of the test eye patients with visual acuity of less than 60 characters (equivalent to decimal visual acuity 0.32)
• Patients diagnosed with binocular myopic chorioretinal atrophy and having atrophy of 1 papillary diameter (1.5 mm) or more in the area within 2 papillary diameter (3.0 mm) including the fovea centralis in the subject eye
• Patients without active choroidal neovascularization

Exclusion criteria

• Patients with abnormal findings that pose a problem in clinical trial participation in screening tests.
• Patients with positive hepatitis B surface (HBs) antigen, Hepatitis C virus (HCV) antibody, Human immunodeficiency virus (HIV) antibody, Human T-lymphotropic virus type 1 (HTLV-1) antibody, syphilis serum reaction
• Patients with allergies to human serum albumin antibiotics, trypsin
• Patients with eye infections
• Patients with other retinal diseases (diabetic retinopathy, hypertensive retinopathy, vascular occlusion)
• Patients with confirmed optic nerve atrophy
• Patients with glaucoma who cannot control intraocular pressure
• Patients with findings associated with myopic traction macular disease (apparent posterior macular tumor, vitreous macular traction, retinal separation, macular hole detachment, macular hole)
• Patients with atrophy in all areas of the circle within 3 papilla diameter (4.5 mm) (9.0 mm in diameter) from the fovea
• Patients with corrected visual acuity of control eye 0.08 or less
• Patients with severe blood disorders, heart failure, liver disorders, and renal disorders
• Patients diagnosed with malignant tumor within 5 years or patients requiring treatment
• Pregnant women, lactating women, patients wishing to become pregnant during the trial period
• Patients who cannot discontinue anticoagulants or antiplatelet drugs before the trial
• Patients with drug addiction or alcoholism
• Patients receiving treatment with vascular endothelial growth factor inhibitor or photodynamic therapy within 4 months prior to transplantation for test eye or 2 months for reference eye.
• Patients who underwent eye surgery (excluding lens reconstruction) within 3 months before transplantation. In the case of cataract surgery, if 7 days or more have passed since surgery and postoperative inflammation is stable, registration is possible.