Episcleral Brachytherapy for Wet Age-Related Macular Degeneration
(NEAMES Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults with wet Age-Related Macular Degeneration (AMD) who haven't improved with FDA-approved anti-VEGF therapy. Participants must have vision of 20/63 or worse in the affected eye, understand the study, and commit to all visits. Exclusions include recent other AMD treatments, certain eye conditions/sizes, uncontrolled diseases like diabetes, prior radiation to head/neck affecting retina, abnormal bleeding risks or anesthesia issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single fraction of 24 Gy Strontium90 episcleral brachytherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- SalutarisMD SMD-DA system
Find a Clinic Near You
Who Is Running the Clinical Trial?
Salutaris Medical Devices, Inc.
Lead Sponsor