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RecruitingNCT07005323PRESERVEUpdated Sep 18, 2026

Progression Suppression and Retinal Regression in VEGF-resistant AMD

An interventional study of Pars plana vitrectomy in Neovascular Age-related Macular Degeneration (AMD), sponsored by PharmaBio Corporation. Recruiting at 3 sites in Japan. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by PharmaBio Corporation · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Sep 2024, registered Mar 2025).
  • Started Sep 2024; still recruiting 2 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Neovascular Age-related Macular Degeneration (AMD)
03

In context

Lead sponsor

PharmaBio Corporation is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Therapeuitic group

    One sheet of PAL-222 is implanted into the subretinal space of either of eyes through pars plana vitrectomy.

    Procedure: Pars plana vitrectomy

Interventions

  • ProcedurePars plana vitrectomy

    One sheet of PAL-222 is implanted into the subretinal space of either of eyes through pars plana vitrectomy.

06

What researchers measure

Primary outcomes

  1. Safety Evaluation: Incidence, type, and severity of Adverse Events (AE)

    Time frame: 52 weeks

07

Study locations

3 of 3 sites recruiting
  • Nagoya City University Hospital
    Nagoya, Aichi-ken 467-8602, Japan
    Recruiting
  • Hyogo Prefectural Amagasaki General Medical Center
    Amagasaki, Hyōgo 660-8550, Japan
    Recruiting
  • Yamaguchi University Hospital
    Ube, Ymaguchi 755-8505, Japan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07005323
Lead sponsor
PharmaBio Corporation
Responsible party
Sponsor
First posted
Jun 5, 2025
Start date
Sep 12, 2024
Primary completion
Aug 2029 (estimated)
Completion
Aug 2029 (estimated)
Last update
Sep 18, 2026

Study contacts

Hitoshi Kusano, M.D.
Contact
clinicaltrial@pharmabio.co.jp
+81 44-742-9980
Hitoshi Kusano, M.D.
study chair · PhamaBio Coorporation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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