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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05658237
Recruitment Status : Recruiting
First Posted : December 20, 2022
Last Update Posted : March 20, 2023
Sponsor:
Information provided by (Responsible Party):
PharmaBio Corporation

Study Description
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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.


Condition or disease Intervention/treatment Phase
Myopic Chorioretinal Atrophy Procedure: Pars plana vitrectomy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/IIa Clinical Study of PAL-222 Targeting Patients With Myopic Chorioretinal Atrophy (PAMyCA)
Actual Study Start Date : February 17, 2023
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : October 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05658237


Contacts
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Contact: Toshihiko Sugioka +81 44-589-6479 clinicaltrial@pharmabio.co.jp

Locations
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Japan
Nagoya city university hospital Recruiting
Nagoya, Aichi, Japan
Sponsors and Collaborators
PharmaBio Corporation
Investigators
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Study Director: Hitoshi Kusano, M.D. PhamaBio Coorporation
More Information
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Responsible Party: PharmaBio Corporation
ClinicalTrials.gov Identifier: NCT05658237    
Other Study ID Numbers: PAL-222-P1
First Posted: December 20, 2022    Key Record Dates
Last Update Posted: March 20, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PharmaBio Corporation:
regenerative product
mesenchymal stem cell
Additional relevant MeSH terms:
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Myopia
Atrophy
Pathological Conditions, Anatomical
Refractive Errors
Eye Diseases