Progression Suppression and Retinal Regression in VEGF-resistant AMD
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 intraoc
| Condition(s) | Neovascular Age-related Macular Degeneration (AMD) |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | Inclusion Criteria: 1. Patients aged between 50 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 60 letters (equivalent to decimal vision of 0.32) 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 (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. ④ Patients with cystoid ma |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Lead sponsor | PharmaBio Corporation |
| Locations | Ube, Ymaguchi, Japan |
| Start date | 2024-09-12 |
| NCT ID | NCT07005323 |
| Official listing | https://clinicaltrials.gov/study/NCT07005323 |