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

The goal of this clinical trial is to assess efficacy and safety in patients with myopic chorioretinal atrophy.The main question it aims to answer are:• Percentage of changes in the chorioretinal atrophic areaParticipants will be implanted one sheet of PAL-222 into the subretinal space through pars plana vitrectomy.Researchers will compare non-therapeutic eye to see if the changes is significant different.

Inclusion Criteria:Patients aged 20 years or older at the time of consent acquisitionPatients 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 DCorrected 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 eyePatients without active choroidal neovascularizationExclusion 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 reactionPatients with allergies to human serum albumin antibiotics, trypsinPatients with eye infectionsPatients with other retinal diseases (diabetic retinopathy, hypertensive retinopathy, vascular occlusion)Patients with confirmed optic nerve atrophyPatients with glaucoma who cannot control intraocular pressurePatients 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 foveaPatients with corrected visual acuity of control eye 0.08 or lessPatients with severe blood disorders, heart failure, liver disorders, and renal disordersPatients diagnosed with malignant tumor within 5 years or patients requiring treatmentPregnant women, lactating women, patients wishing to become pregnant during the trial periodPatients who cannot discontinue anticoagulants or antiplatelet drugs before the trialPatients with drug addiction or alcoholismPatients receiving treatment with vascular endothelial growth factor inhibitor or photodynamic therapy within 6 months prior to transplantationPatients 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.