Episcleral Brachytherapy for the Treatment of Wet AMD (NEAMES)

  • STATUS
    Recruiting
  • End date
    Dec 26, 2022
  • participants needed
    12
  • sponsor
    Salutaris Medical Devices, Inc.
Updated on 26 March 2022

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.

Description

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

Details
Condition Macular Degeneration, Choroidal Neovascularization
Treatment episcleral brachytherapy, Anti-VEGF
Clinical Study IdentifierNCT02988895
SponsorSalutaris Medical Devices, Inc.
Last Modified on26 March 2022

Eligibility

Yes No Not Sure

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
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