Neovascular Age-related Macular Degeneration (AMD)PRESERVENCT07005323
Progression Suppression and Retinal Regression in VEGF-resistant AMD
A study testing Pars plana vitrectomy in people with Neovascular Age-related Macular Degeneration (AMD), run by PharmaBio Corporation at 3 sites in Japan.
Trial summary
The goal of this clinical trial is to assess safety and efficacy in patients with Neovascular Age-related Macular Degeneration with no response to existing therapy. The main measures it aims to answer are: Investigation of adverse events Changes in clinical testing data Changes in vital signs Changes in intraocular… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neovascular Age-related Macular Degeneration (AMD)
- 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
- 3 sitesJapan
- Study dates
- 12 Sep 2024to Aug 2029
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 85 years at the time of consent acquisition
- Patients diagnosed neovascular AMD in one or both eyes
- Patients with corrected letter vision in the subject eye of 20 letters or more (equivalent to decimal vision of 0.05) and less than 70 letters (equivalent to decimal vision of 0.5)
- Patients who apply to one or more of the followings:
- ① RPE defect site in the RPE tear includes the Fovea
- ② The Macular atrophy confirmed by low fundus autofluorescence extends to the fovea
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- ③ Patients with choroidal thinning (200 micrometer and less), and subretinal fluid resistant to standard treatment
- ④ Patients with cystoid macular degeneration with photoreceptor cell loss and intraretinal fluid above fibrovascular pigment epithelial detachment
- Patients who had little improvement in exudative changes, with persistent exudative changes to date, and no improvement, or deterioration of vision in two treatments with VEGF inhibitor therapy (two consecutive administration at intervals of 11 weeks +/- 3 days or less within the past year), after existing therapy
Who cannot join
- Patients with fibrovascular pigment epithelial detachment (thickness 150 micrometer or more) in the subject eye.
- Patients with hard exudates in the subretinal or intraretinal area in the subject eye.
- Patients in whom polypoid lesions are observed in the subject eye on fundus examination, OCT, fluorescein angiography, etc.
- Patients with subretinal hemorrhage (1 disc diameter or greater) or hemorrhagic pigment epithelial detachment (of any size) in the study eye.
- Patients with eye infections
- Patients with a history of retinal vascular disease other than neovascular AMD, retinal degenerative disease, rhegmatogenous retinal detachment, macular hole, premacular membrane with retinal wall, uveitis, or other ocular inflammatory disease in the subject eye.
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- Patients with optic nerve atrophy in the subject eye
- Patients with progressive glaucoma in the subject eye (in whom intraocular pressure is not controlled, or visual field loss is progressive or has already spread to the macula)
- Patients with severe myopia in the subject eye (axial length of 26.5 mm or more, or spherical equivalent of -7.0 D or less in phakic eyes)
- Patients who have undergone intraocular surgery in the subject eye. (In the case of cataract surgery, patients may be enrolled if they have had no endophthalmitis or other complications, have progressed well, and more than 7 days have passed since the surgery)
- Patients with corrected visual acuity of the non-subject eye 0.1 or less
- (Missing number)
- Patients with abnormal findings that pose a problem in clinical trial participation in screening tests.
- Patients with positive HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody, syphilis serum reaction
- Patients with allergies to human serum albumin antibiotics, trypsin
- 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 anticoagulant or antiplatelet let drugs within the appropriate timeframe specified by the principal investigator or a sub-investigator
- Patients with drug addiction or alcoholism
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan3 sites, 3 recruiting
- Recruiting
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki, Hyōgo, 660-8550
Hitoshi Kusano, M.D., +81 6-6480-7000
Hitoshi Kusano, M.D., clinicaltrial@pharmabio.co.jp
- Recruiting
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602
Hitoshi Kusano, M.D., +81 52-851-5511
Hitoshi Kusano, M.D., clinicaltrial@pharmabio.co.jp
- Recruiting
Yamaguchi University Hospital
Ube, Ymaguchi, 755-8505
Hitoshi Kusano, M.D., +81 836-22-2428, ychiken@yamaguchi-u.ac.jp
Hitoshi Kusano, M.D., clinicaltrial@pharmabio.co.jp
About this study
Official title: Phase I/IIa Clinical Study of PAL-222 Targeting Patients With Neovascular Age-related Macular Degeneration (AMD) That Shows no Response to Existing Therapy
The goal of this clinical trial is to assess safety and efficacy in patients with Neovascular Age-related Macular Degeneration with no response to existing therapy.
The main measures it aims to answer are:
- Investigation of adverse events
- Changes in clinical testing data
- Changes in vital signs
- Changes in intraocular pressure of the therapeutic eye
- Changes in testing of anterior segment of the therapeutic eye Participants will be implanted one sheet of PAL-222 into the subretinal space through pars plana vitrectomy.
Researchers will compare pre and post implantation of therapeutic eye to see if any safety issues recognized
- Being tested
- Pars plana vitrectomy
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 |
|---|---|---|
| Therapeuitic group | Experimental | One sheet of PAL-222 is implanted into the subretinal space of either of eyes through pars plana vitrectomy. Receives: Procedure: Pars plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluation: Incidence, type, and severity of Adverse Events (AE)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start12 Sep 2024
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular Degeneration (AMD)Studies 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 chair, PhamaBio Coorporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005323
- Sponsor's protocol ID
- PAL-222-P2
- Acronym
- PRESERVE
- Status last verified
- Sep 2026
- First submitted
- 3 Mar 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 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 Neovascular Age-related Macular Degeneration (AMD) That Shows no Response to Existing Therapy
- ClinicalTrials.gov ID
- NCT07005323
- Acronym / sponsor ID
- PRESERVE / PAL-222-P2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- PharmaBio CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 5 Jun 2025 (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 safety and efficacy in patients with Neovascular Age-related Macular Degeneration with no response to existing therapy.
The main measures it aims to answer are:
- Investigation of adverse events
- Changes in clinical testing data
- Changes in vital signs
- Changes in intraocular pressure of the therapeutic eye
- Changes in testing of anterior segment of the therapeutic eye Participants will be implanted one sheet of PAL-222 into the subretinal space through pars plana vitrectomy.
Researchers will compare pre and post implantation of therapeutic eye to see if any safety issues recognized
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapeuitic group | Experimental | Procedure: Pars plana vitrectomyOne sheet of PAL-222 is implanted into the subretinal space of either of eyes through pars plana vitrectomy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged between 18 and 85 years at the time of consent acquisition
- Patients diagnosed neovascular AMD in one or both eyes
- Patients with corrected letter vision in the subject eye of 20 letters or more (equivalent to decimal vision of 0.05) and less than 70 letters (equivalent to decimal vision of 0.5)
- Patients who apply to one or more of the followings:
- ① RPE defect site in the RPE tear includes the Fovea
Key exclusion criteria (20 listed)
- Patients with fibrovascular pigment epithelial detachment (thickness 150 micrometer or more) in the subject eye.
- Patients with hard exudates in the subretinal or intraretinal area in the subject eye.
- Patients in whom polypoid lesions are observed in the subject eye on fundus examination, OCT, fluorescein angiography, etc.
- Patients with subretinal hemorrhage (1 disc diameter or greater) or hemorrhagic pigment epithelial detachment (of any size) in the study eye.
- Patients with eye infections
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 | Therapeuitic group |
Primary outcome
Safety Evaluation: Incidence, type, and severity of Adverse Events (AE)
Time frame: 52 weeks
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 18 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Hitoshi Kusano, M.D. study chair
PhamaBio Coorporation
3 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 Neovascular Age-related Macular Degeneration (AMD), run by PharmaBio Corporation at 3 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 9 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 18 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 3 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?
Contact Hitoshi Kusano, M.D. (+81 44-742-9980, clinicaltrial@pharmabio.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Evaluation: Incidence, type, and severity of Adverse Events (AE) (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2026.