Progression Suppression and Retinal Regression in VEGF-resistant AMD
NCT07005323 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2025-06-05
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
- PROCEDURE
-
Pars plana vitrectomy
One sheet of PAL-222 is implanted into the subretinal space of either of eyes through pars plana vitrectomy.
Sponsors & Collaborators
-
PharmaBio Corporation
lead INDUSTRY
Principal Investigators
-
Hitoshi Kusano, M.D. · PhamaBio Coorporation
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-12
- Primary Completion
- 2027-03-31
- Completion
- 2027-03-31
Countries
- Japan
Study Locations
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