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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopic Chorioretinal Atrophy
• Intervention / Treatment: Procedure: Pars plana vitrectomy

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Nagoya, Aichi, Japan
      • Nagoya City University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: PharmaBio Corporation
• Investigators: Study Director: Hitoshi Kusano, M.D., PhamaBio Coorporation

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2023
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: mesenchymal stem cell; regenerative product
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Eye Diseases; Refractive Errors; Myopia; Atrophy
• Other Study ID Numbers: PAL-222-P1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No