Episcleral Brachytherapy for Wet Age-Related Macular Degeneration

(NEAMES Trial)

Recruiting at 1 trial location

Overseen By Mary Drew, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Salutaris Medical Devices, Inc.

Must be taking: Anti-VEGF

Must not be taking: Anticoagulants, Dual anti-platelets

Disqualifiers: Diabetes, Glaucoma, High myopia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

11 Participants Needed

Trial Summary

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.

Eligibility Criteria

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

My eye condition didn't improve with specific eye injections.

I have been diagnosed with wet age-related macular degeneration.

I am able to have tests and surgeries.

Exclusion Criteria

I do not have serious eye conditions other than nAMD that could affect my vision.

I cannot have treatments that require being put to sleep or numbed.

I have type I or type II diabetes.

Treatment Details

Interventions

• SalutarisMD SMD-DA system

Trial Overview The SalutarisMD SMD-DA system for episcleral brachytherapy is being tested as a one-time treatment for those not responding to standard anti-VEGF therapy. This open-label, non-randomized study doesn't change usual care during follow-up and aims to assess safety and feasibility across multiple sites.

Participant Groups

Group I: episcleral brachytherapy Experimental Treatment 1 Intervention

single fraction of 24 Gy Strontium90 episcleral brachytherapy

Who Is Running the Clinical Trial?

Salutaris Medical Devices, Inc.

Lead Sponsor

Trials

2

Recruited

170+