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

• ClinicalTrials.gov Identifier: NCT05658237
• Recruitment Status: Recruiting
• First Posted: December 20, 2022
• Last Update Posted: January 31, 2024
• Sponsor: PharmaBio Corporation
• Information provided by (Responsible Party): PharmaBio Corporation

Tracking Information

• First Submitted Date: December 12, 2022
• First Posted Date: December 20, 2022
• Last Update Posted Date: January 31, 2024
• Actual Study Start Date: February 17, 2023
• Estimated Primary Completion Date: January 31, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 12, 2022)

Percentage of changes in the chorioretinal atrophic area [ Time Frame: Just before transplantation，after 3days and 1,2,4,8,12,16,20,24,32,40,52weeks ]

Assesment by the principal investigator or sub-investigator will be conducted and central committee will adjudicate the assessment.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Myopic Chorioretinal Atrophy

Intervention

Procedure: Pars plana vitrectomy

One sheet of PAL-222 is implanted into the subretinal space of either of eyes through pars plana vitrectomy.

Study Arms

Experimental: therapeutic group

Intervention: Procedure: Pars plana vitrectomy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 12, 2022): 10
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 31, 2026
• Estimated Primary Completion Date: January 31, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Hitoshi Kusano, M.D.; +81 44-589-6479; clinicaltrial@pharmabio.co.jp

• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT05658237
• Other Study ID Numbers: PAL-222-P1
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: PharmaBio Corporation
• Original Responsible Party: Same as current
• Current Study Sponsor: PharmaBio Corporation
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Hitoshi Kusano, M.D.; PhamaBio Coorporation

• PRS Account: PharmaBio Corporation
• Verification Date: January 2024