Tiny implant aims to restore sight in eyes that resist standard AMD therapy
NCT ID NCT07005323
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Researchers are testing a new treatment called PAL-222 for people with neovascular age-related macular degeneration (AMD) whose disease has not responded to existing therapies. The study will enroll up to 10 adults aged 18 to 85 with this condition. Each participant will have a small sheet of PAL-222 implanted into the back of one eye during a surgical procedure called pars plana vitrectomy. The trial aims to see whether the implant is safe and whether it shows any signs of helping vision.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A sheet implant called PAL-222 placed into the subretinal space of the eye
- What this could lead to
- If the implant proves safe and shows signs of benefit, it could offer a new option for people with neovascular AMD whose disease has not responded to current treatments.
- What could go wrong
- This is a very small, early-stage trial with only 10 participants, so safety and effectiveness are far from established. The surgical implant carries risks such as bleeding, infection, or retinal damage, and the treatment may not help vision.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients aged between 18 and 85 years at the time of consent acquisition 2. Patients diagnosed neovascular AMD in one or both eyes 3. 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) 4. 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 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 5. 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 Exclusion Criteria: 1. Patients with fibrovascular pigment epithelial detachment (thickness 150 micrometer or more) in the subject eye. 2. Patients with hard exudates in the subretinal or intraretinal area in the subject eye. 3. Patients in whom polypoid lesions are observed in the subject eye on fundus examination, OCT, fluorescein angiography, etc. 4. Patients with subretinal hemorrhage (1 disc diameter or greater) or hemorrhagic pigment epithelial detachment (of any size) in the study eye. 5. Patients with eye infections 6. 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. 7. Patients with optic nerve atrophy in the subject eye 8. 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) 9. 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) 10. 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) 11. Patients with corrected visual acuity of the non-subject eye 0.1 or less 12. (Missing number) 13. Patients with abnormal findings that pose a problem in clinical trial participation in screening tests. 14. Patients with positive HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody, syphilis serum reaction 15. Patients with allergies to human serum albumin antibiotics, trypsin 16. Patients with severe blood disorders, heart failure, liver disorders, and renal disorders 17. Patients diagnosed with malignant tumor within 5 years or patients requiring treatment 18. Pregnant women, lactating women, patients wishing to become pregnant during the trial period 19. Patients who cannot discontinue anticoagulant or antiplatelet let drugs within the appropriate timeframe specified by the principal investigator or a sub-investigator 20. Patients with drug addiction or alcoholism
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Hyogo Prefectural Amagasaki General Medical Center
RECRUITINGAmagasaki, Hyōgo, 660-8550, Japan
Contact Email: •••••@•••••
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Nagoya City University Hospital
RECRUITINGNagoya, Aichi-ken, 467-8602, Japan
Contact Email: •••••@•••••
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Yamaguchi University Hospital
RECRUITINGUbe, Ymaguchi, 755-8505, Japan
Contact Email: •••••@•••••
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