Actively Recruiting
Progression Suppression and Retinal Regression in VEGF-resistant AMD
Led by PharmaBio Corporation · Updated on 2025-06-05
10
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Progression Suppression and Retinal Regression in VEGF-resistant AMD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 50 and 85 years at the time of consent acquisition
- Patients diagnosed with neovascular AMD in one or both eyes
- Patients with corrected letter vision in the subject eye between 20 and 59 letters (decimal vision 0.05 to less than 0.32)
- Patients meeting one or more of the following: RPE defect involving the fovea, macular atrophy extending to the fovea, choroidal thinning (150 micrometer or less) with subretinal fluid resistant to treatment and high activity but no hard exudates or subretinal hemorrhage, or cystoid macular degeneration with photoreceptor cell loss and intraretinal fluid above fibrovascular pigment epithelial detachment without hard exudates or subretinal hemorrhage
- Patients with little improvement in exudative changes and no improvement or worsening of vision after two consecutive VEGF inhibitor treatments given 4-8 weeks apart
You will not qualify if you...
- Patients with fibrovascular pigment epithelial detachment (thickness 50 �b5m or more) in the subfoveal area of the subject eye
- Patients with hard exudates in the subretinal or intraretinal area in the subject eye
- Patients with eye infections
- Patients with 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
- Patients with optic nerve atrophy in the subject eye
- Patients with progressive glaucoma in the subject eye with uncontrolled intraocular pressure or progressive visual field loss
- Patients with severe myopia in the subject eye (axial length 26.5 mm or more or spherical equivalent of -7.0 D or less in phakic eyes)
- Patients who had intraocular surgery in the subject eye (except cataract surgery without complications done more than 3 months ago)
- Patients with corrected visual acuity of the non-subject eye 0.1 or less
- Patients receiving or scheduled to receive VEGF inhibitor treatment in the non-subject eye during the study
- Patients with abnormal findings that interfere with clinical trial participation
- Patients positive for HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody, or syphilis serum reaction
- Patients allergic to human serum albumin, antibiotics, or trypsin
- Patients with severe blood disorders, heart failure, liver or kidney disorders
- Patients diagnosed with malignant tumor within 5 years or requiring treatment
- Pregnant or breastfeeding women or patients planning pregnancy during the trial
- Patients unable to stop anticoagulants or antiplatelet drugs before the trial
- Patients with drug addiction or alcoholism
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Yamaguchi University Hospital
Ube, Ymaguchi, Japan, 755-8505
Actively Recruiting
Research Team
H
Hitoshi Hitoshi Kusano, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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