Myopic Chorioretinal AtrophyNCT05658237
Clinical Study of PAL-222 Targeting Patients With Myopic Chorioretinal Atrophy (PAMyCA)
A study testing Pars plana vitrectomy in people with Myopic Chorioretinal Atrophy, run by PharmaBio Corporation at 2 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Myopic Chorioretinal Atrophy
- What is being tested?
- Pars plana vitrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesJapan
- Study dates
- 17 Feb 2023to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Nagoya city university hospital
Nagoya, Aichi-ken
Yamguchi University Hospital
Ube
About this study
Official title: Phase I/IIa Clinical Study of PAL-222 Targeting Patients With Myopic Chorioretinal Atrophy (PAMyCA)
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.
- Conditions
- Myopic Chorioretinal Atrophy
- Being tested
- Pars plana vitrectomy
- Keywords
- regenerative product, mesenchymal stem cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pars plana vitrectomyProcedure or surgery
One sheet of PAL-222 is implanted into the subretinal space of either of eyes through pars plana vitrectomy.
| Study group | Role | What they receive |
|---|---|---|
| therapeutic group | Experimental | Not described Receives: Procedure: Pars plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Just before transplantation，after 3days and 1,2,4,8,12,16,20,24,32,40,52,60,72,84,96-104weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start17 Feb 2023
- Primary completionJun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myopic Chorioretinal AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PharmaBio Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hitoshi Kusano, M.D., Study director, PhamaBio Coorporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658237
- Sponsor's protocol ID
- PAL-222-P1
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2022
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nagano N, Hirano Y, Kimura M, Morita H, Yasukawa T. Preclinical study of novel human allogeneic adipose tissue-derived mesenchymal stem cell sheets toward a first-in-human clinical trial for myopic chorioretinal atrophy. Stem Cell Res Ther. 2024 Dec 23;15(1):498. doi: 10.1186/s13287-024-04118-z.
PubMed 39716323
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IIa Clinical Study of PAL-222 Targeting Patients With Myopic Chorioretinal Atrophy (PAMyCA)
- ClinicalTrials.gov ID
- NCT05658237
- Acronym / sponsor ID
- PAL-222-P1
- Conditions
- Myopic Chorioretinal Atrophy
- Keywords
- regenerative product, mesenchymal stem cell
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- PharmaBio CorporationIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| therapeutic group | Experimental | Procedure: Pars plana vitrectomy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pars plana vitrectomyOne sheet of PAL-222 is implanted into the subretinal space of either of eyes through pars plana vitrectomy. | Procedure or surgery | therapeutic group |
Primary outcome
Percentage of changes in the chorioretinal atrophic area
Time frame: Just before transplantation，after 3days and 1,2,4,8,12,16,20,24,32,40,52,60,72,84,96-104weeks
Assesment by the principal investigator or sub-investigator will be conducted and central committee will adjudicate the assessment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Derived from this study: PubMed 39716323Nagano N, Hirano Y, Kimura M, Morita H, Yasukawa T. Preclinical study of novel human allogeneic adipose tissue-derived mesenchymal stem cell sheets toward a first-in-human clinical trial for myopic chorioretinal atrophy. Stem Cell Res Ther. 2024 Dec 23;15(1):498. doi: 10.1186/s13287-024-04118-z.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hitoshi Kusano, M.D. study director
PhamaBio Coorporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pars plana vitrectomy in people with Myopic Chorioretinal Atrophy, run by PharmaBio Corporation at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of changes in the chorioretinal atrophic area (time frame: Just before transplantation，after 3days and 1,2,4,8,12,16,20,24,32,40,52,60,72,84,96-104weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05658237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.