episcleral brachytherapy for the treatment of wet amd

Conditions: Macular Degeneration, Choroidal Neovascularization

Summary: this is a prospective, multi-site, safety and feasibility study of the salutarismd smd-da system for retrobulbar minimally invasive episcleral brachytherapy device in patients receiving and not responding to anti-vegf therapy for namd. the trial will be open label and non-randomized. the study intervention is a one-time intervention and requires no alteration to the standard of care during the follow-up period.

subjects will receive a single brachytherapy treatment and 36 months of follow-up.

Eligibility criteria:
inclusion criteria: * diagnosis of active cnv or pcv due to namd * poor or non-responsive to fda approved intravitreal anti-vegf therapy for namd * bcva 20/63 or worse snellen equivalent in the study eye * ability to understand nature/purpose of trial and to provide informed consent * ability to undergo diagnostic tests and surgical interventions * ability to follow instructions and complete the trial including all scheduled visits and follow-up exclusion criteria: * neovascularization other than due to amd * sub-foveal lesion hemorrhage obscuring \>50% of lesion * targeted neovascular lesion with greatest linear dimension \>3750 microns or \<1000 microns as determined by angiography * presence of subretinal fibrosis, including disciform scar, or retinal pigment epithelial (rpe) atrophy that is extensive or foveal threatening in the study eye * an existing retinal pigment epithelial (rpe) tear * previous treatment (excluding vitamins) for namd in the study eye other than anti-vegf therapy in the last 6 months * a change in anti-vegf agent in the previous two administrations * anticipate a change to the anti-vegf agent during the conduct of the study * other clinically significant ocular co-morbidity including, but not limited to, glaucoma, optic neuropathy of any cause, maculopathy / retinopathy of any cause other than namd, scleritis, enophthalmos, microphthalmia, or other co-morbidities that in the investigator's opinion could require medical or surgical intervention to prevent or treat visual loss or media opacity that might result from that condition (i.e. severe cataracts). * previous intraocular surgery in study eye other than for uncomplicated phacoemulsification cataract extraction * high myopia indicated by a history of refractive error of - 6d or greater (spherical equivalent), demonstrated myopic degeneration, or axial length of \>26.5mm. * subjects with orbital structural abnormalities, such as small (axial length \<21 mm), deep set globes or other globe dystopias that, in the investigator's clinical judgment, would require a change in the angle of insertion or increase the risk of structural damage from retrobulbar anesthesia, sub-tenon's anesthesia, or retrobulbar device positioning. * media opacity sufficient to preclude adequate fundoscopy, oct, or angiography * uncontrolled systemic diseases (e.g. controlled hypertension is acceptable) * type i or type ii diabetes mellitus * any previous therapeutic radiation to the head or neck or other areas that may have resulted in a radiation dose to the retina. * on anticoagulation or dual anti-platelet therapy with abnormal coagulation panel results. * patient unsuitable for iv or local anesthesia * any contraindication to anti-vegf, fluorescein, indocyanine green, topical and local anesthetics, topical antiseptics, or topical antibiotics to be used during the study * active ocular or periocular infection or intraocular inflammation * fellow eye with a bcva of 20/63 snellen equivalent or worse, with advanced amd (neovascular or non-exudative amd with foveal geographic atrophy), or other vision threatening disease that is not eligible for vision restoring treatment (i.e. inoperable cataracts). * fellow eye is receiving anti-vegf therapy * have received any investigational treatment for any indication in the previous 30 days * any condition which, in the investigators' opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule or other study conduct

Keywords: brachytherapy wet amd