Stopping progression and reducing retinal lesions in VEGF-resistant AMD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study implants a single sheet of PAL-222 into the subretinal space via pars plana vitrectomy in patients with neovascular age-related macular degeneration who have not responded to standard anti‑VEGF therapy. Participants are monitored before and after implantation for adverse events and for changes in clinical testing data, vital signs, intraocular pressure, and anterior segment findings in the treated eye. Entry requires corrected letter vision between 20 and 59 and specific retinal findings such as foveal RPE defects, macular atrophy reaching the fovea, choroidal thinning with persistent subretinal fluid, or cystoid macular degeneration with photoreceptor loss. Procedures and follow-up occur at a single center and outcomes are compared to each participant's baseline rather than to a randomized control arm.

Why it matters

Who can join: the full rules

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

Where it's running

• Nagoya City University Hospital
  Nagoya, Aichi-ken, Japan Recruiting
• Hyogo Prefectural Amagasaki General Medical Center
  Amagasaki, Hyōgo, Japan Recruiting
• Yamaguchi University Hospital
  Ube, Ymaguchi, Japan Recruiting

Study contacts

• Study coordinator: Hitoshi Kusano, M.D.
• Email: clinicaltrial@pharmabio.co.jp
• Phone: +81 44-742-9980

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• IBI302 treatment for neovascular age-related macular degeneration

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.