Progression Suppression and Retinal Regression in VEGF-resistant AMD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
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
This trial does not accept healthy volunteersQualifiers
Patients aged between 18 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 70 letters (equivalent to decimal vision of 0.5)
Patients who had little improvement in exudative changes, with persistent exudative changes to date, and no improvement, or deterioration of vision in two treatments with VEGF inhibitor therapy (two consecutive administration at intervals of 11 weeks +/- 3 days or less within the past year), after existing therapy
Disqualifiers
Patients with fibrovascular pigment epithelial detachment (thickness 150 micrometer or more) in the subject eye.
Patients with hard exudates in the subretinal or intraretinal area in the subject eye.
Patients in whom polypoid lesions are observed in the subject eye on fundus examination, OCT, fluorescein angiography, etc.
Patients with subretinal hemorrhage (1 disc diameter or greater) or hemorrhagic pigment epithelial detachment (of any size) in the study eye.
Trial design
Design model
Single group
Treatments tested in this trial
Pars plana vitrectomy
Procedure/SurgeryOne sheet of PAL-222 is implanted into the subretinal space of either of eyes through pars plana vitrectomy.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Therapeuitic groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety Evaluation: Incidence, type, and severity of Adverse Events (AE)
Time frame
52 weeksSponsors and contacts
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Source ClinicalTrials.gov