Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Researchers will compare pre and post implantation of therapeutic eye to see if any safety issues recognized
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeuitic group | Experimental | One sheet of PAL-222 is implanted into the subretinal space of either of eyes through pars plana vitrectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pars plana vitrectomy | Procedure | One sheet of PAL-222 is implanted into the subretinal space of either of eyes through pars plana vitrectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Evaluation: Incidence, type, and severity of Adverse Events (AE) | 52 weeks |
Not provided
Not provided
Inclusion Criteria:
Patients aged between 50 and 85 years at the time of consent acquisition
Patients diagnosed neovascular AMD in one or both eyes
Patients with corrected letter vision in the subject eye of 20 letters or more (equivalent to decimal vision of 0.05) and less than 60 letters (equivalent to decimal vision of 0.32)
Patients who apply to one or more of the followings:
â‘ RPE defect site in the RPE tear includes the Fovea
â‘¡ The Macular atrophy confirmed by low fundus autofluorescence extends to the fovea
â‘¢ Patients with choroidal thinning (150 micrometer and less), subretinal fluid resistant to standard treatment, and high activity, but without hard exudated or subretinal hemorrhage which are indicators of the high risk of visual impairment.
â‘£ Patients with cystoid macular degeneration with photoreceptor cell loss and intraretinal fluid above fibrovascular pigment epithelial detachment, but without hard exudates or subretinal hemorrhage.
Patients who had little improvement in exudative changes and no improvement, or deterioration of vision in recent two treatment with VEGF inhibitor therapy (two consecutive administration at 4-8-week intervals), after existing therapy
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hitoshi Hitoshi Kusano, M.D. | Contact | +81 44-589-6479 | clinicaltrial@pharmabio.co.jp |
| Name | Affiliation | Role |
|---|---|---|
| Hitoshi Kusano, M.D. | PhamaBio Coorporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yamaguchi University Hospital | Recruiting | Ube | Ymaguchi | 755-8505 | Japan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided