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

Last updated: January 30, 2024
Sponsor: PharmaBio Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myopia

Treatment

Pars plana vitrectomy

Clinical Study ID

NCT05658237
PAL-222-P1
  • Ages > 20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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) orpatients 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 60characters (equivalent to decimal visual acuity 0.32)
  • Patients diagnosed with binocular myopic chorioretinal atrophy and having atrophy of 1papillary 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

Exclusion Criteria:

  • Patients with abnormal findings that pose a problem in clinical trial participation inscreening 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 (apparentposterior macular tumor, vitreous macular traction, retinal separation, macular holedetachment, 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 renaldisorders
  • Patients diagnosed with malignant tumor within 5 years or patients requiring treatment
  • Pregnant women, lactating women, patients wishing to become pregnant during the trialperiod
  • 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 orphotodynamic therapy within 4 months prior to transplantation for test eye or 2 monthsfor reference eye.
  • Patients who underwent eye surgery (excluding lens reconstruction) within 3 monthsbefore transplantation. In the case of cataract surgery, if 7 days or more have passedsince surgery and postoperative inflammation is stable, registration is possible.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Pars plana vitrectomy
Phase:
Study Start date:
February 17, 2023
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Nagoya city university hospital

    Nagoya, Aichi
    Japan

    Active - Recruiting

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