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

Study Overview
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Brief Summary
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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 area Participants 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.

Official Title
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Phase I/IIa Clinical Study of PAL-222 Targeting Patients With Myopic Chorioretinal Atrophy (PAMyCA)

Conditions
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Myopic Chorioretinal Atrophy

Intervention / Treatment
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* Procedure: Pars plana vitrectomy


Participation Criteria
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Eligibility Criteria
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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 6 months prior to transplantation 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: therapeutic group<br> | Procedure: Pars plana vitrectomy<br>* One sheet of PAL-222 is implanted into the subretinal space of either of eyes through pars plana vitrectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of changes in the chorioretinal atrophic area | Assesment by the principal investigator or sub-investigator will be conducted and central committee will adjudicate the assessment. | Just before transplantation，after 3days and 1,2,4,8,12,16,20,24,32,40,52weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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regenerative product, mesenchymal stem cell