Tiny implant aims to restore sight in eyes that resist standard AMD therapy

NCT ID NCT07005323

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 85 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Hyogo Prefectural Amagasaki General Medical Center

    RECRUITING

    Amagasaki, Hyōgo, 660-8550, Japan

    Contact Email: •••••@•••••

  • Nagoya City University Hospital

    RECRUITING

    Nagoya, Aichi-ken, 467-8602, Japan

    Contact Email: •••••@•••••

  • Yamaguchi University Hospital

    RECRUITING

    Ube, Ymaguchi, 755-8505, Japan

    Contact Email: •••••@•••••

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