Treatment for Myopic Chorioretinal Atrophy Using PAL-222
Phase I/IIa Clinical Study of PAL-222 Targeting Patients With Myopic Chorioretinal Atrophy (PAMyCA)
NA · PharmaBio Corporation · NCT05658237
This study is testing a new treatment called PAL-222 to see if it can help people with myopic chorioretinal atrophy improve their vision after a specific eye surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | PharmaBio Corporation (industry) |
| Locations | 1 site (Nagoya, Aichi) |
| Trial ID | NCT05658237 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of PAL-222, a regenerative product, in patients suffering from myopic chorioretinal atrophy. Participants aged 20 and older will undergo pars plana vitrectomy to implant a sheet of PAL-222 into the subretinal space. The study will measure changes in the chorioretinal atrophic area by comparing treated eyes to non-therapeutic eyes. The goal is to determine if the treatment leads to significant improvements in the condition.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20 and older with significant myopia and diagnosed myopic chorioretinal atrophy.
Not a fit: Patients with active choroidal neovascularization or other serious health conditions may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could potentially restore vision or halt the progression of myopic chorioretinal atrophy in affected patients.
How similar studies have performed: While this approach is innovative, similar studies using regenerative products in ocular conditions have shown promise, but results may vary.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nagoya, Aichi
- Nagoya city university hospital — Nagoya, Aichi, Japan (RECRUITING)
Study contacts
- Study coordinator: Hitoshi Kusano, M.D.
- Email: clinicaltrial@pharmabio.co.jp
- Phone: +81 44-589-6479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myopic Chorioretinal Atrophy, regenerative product, mesenchymal stem cell