Clinical trial NCT05658237: 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
Overall status: RECRUITING
Phase: NA
Conditions: Myopic Chorioretinal Atrophy
Keywords: regenerative product
mesenchymal stem cell
Lead sponsor: PharmaBio Corporation
Sponsor class: INDUSTRY
First posted: 2022-12-20
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of changes in the chorioretinal atrophic area
timeFrame: Just before transplantation，after 3days and 1,2,4,8,12,16,20,24,32,40,52weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya city university hospital
state: Aichi
Study officials:
affiliation: PhamaBio Coorporation
name: Hitoshi Kusano, M.D.
role: STUDY_DIRECTOR
References: