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

Primary Purpose

Myopic Chorioretinal Atrophy

Status
Recruiting
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Pars plana vitrectomy
Sponsored by
PharmaBio Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopic Chorioretinal Atrophy focused on measuring regenerative product, mesenchymal stem cell

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nagoya city university hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

therapeutic group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 12, 2022
Last Updated
March 16, 2023
Sponsor
PharmaBio Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05658237
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2023 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PharmaBio Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopic Chorioretinal Atrophy
Keywords
regenerative product, mesenchymal stem cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
therapeutic group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Pars plana vitrectomy
Intervention Description
One sheet of PAL-222 is implanted into the subretinal space of either of eyes through pars plana vitrectomy.
Primary Outcome Measure Information:
Title
Percentage of changes in the chorioretinal atrophic area
Description
Assesment by the principal investigator or sub-investigator will be conducted and central committee will adjudicate the assessment.
Time Frame
Just before transplantation,after 3days and 1,2,4,8,12,16,20,24,32,40,52weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toshihiko Sugioka
Phone
+81 44-589-6479
Email
clinicaltrial@pharmabio.co.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hitoshi Kusano, M.D.
Organizational Affiliation
PhamaBio Coorporation
Official's Role
Study Director
Facility Information:
Facility Name
Nagoya city university hospital
City
Nagoya
State/Province
Aichi
Country
Japan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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