Progression Suppression and Retinal Regression in VEGF-resistant AMD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorPharmaBio Corporation
About this trial
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
Eligibility criteria
Qualifiers
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 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
Disqualifiers
Patients with fibrovascular pigment epithelial detachment (thickness 50 µm or more) in the subfoveal area in the subject eye.
Patients with hard exudates in the subretinal or intraretinal area in the subject eye.
Patients with eye infections
Patients with a history of 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.
Trial design
Treatments tested in this trial
- Pars plana vitrectomy
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov