Macular Degeneration, Choroidal Neovascularization
Conditions
Keywords
Brachytherapy, Wet AMD
Brief 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.
Detailed description
Subjects will receive a single brachytherapy treatment and 36 months of follow-up.
Interventions
RADIATIONepiscleral brachytherapy
The study intervention is an outpatient, ambulatory procedure performed under local anesthesia with anesthesia assist.
Sponsors
Salutaris Medical Devices, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the study intervention | 1 day | Investigator ability to place the device and deliver a therapeutic dose |
| Safety of the study intervention | 26 weeks | Adverse event assessment |
| Tolerability of the study intervention | During procedure | Subject pain score during procedure |
Countries
United States
Outcome results
None listed