NCT07005323

Progression Suppression and Retinal Regression in VEGF-resistant AMD

Phase I/IIa Clinical Study of PAL-222 Targeting Patients With Neovascular Age-related Macular Degeneration (AMD) That Shows no Response to Existing Therapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: PharmaBio Corporation · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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

Conditions

• Neovascular Age-related Macular Degeneration (AMD)

Interventions

Type	Name	Description
PROCEDURE	Pars plana vitrectomy	One sheet of PAL-222 is implanted into the subretinal space of either of eyes through pars plana vitrectomy.

Timeline

• Start date: 2024-09-12
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2025-06-05
• Last updated: 2025-06-05

Locations

1 site across 1 country: Japan