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Episcleral Brachytherapy for Wet Age-Related Macular Degeneration (NEAMES Trial)

N/A
Waitlist Available
Research Sponsored by Salutaris Medical Devices, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of active CNV or PCV due to nAMD
Poor or non-responsive to FDA approved intravitreal anti-VEGF therapy for nAMD
Must not have
Patient unsuitable for IV or local anesthesia
Type I or type II diabetes mellitus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new minimally invasive episcleral brachytherapy device for patients with nAMD who are not responding to anti-VEGF therapy. The device is inserted retrobulbar and only requires a one-time intervention.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical risks associated with surgical interventions such as infection risk at the surgery site, inflammation inside or around the eye, bleeding complications due to local anesthesia administration or device positioning.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with wet age-related macular degeneration.
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My eye condition didn't improve with specific eye injections.
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I understand the trial's purpose and can give informed consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot have treatments that require being put to sleep or numbed.
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I have type I or type II diabetes.
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My other eye has severe vision loss due to AMD or another untreatable condition.
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My other eye is being treated with anti-VEGF medication.
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My eye has scar tissue or damage in the retina that threatens my central vision.
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I have had radiation therapy to my head, neck, or eyes.
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I have an eye or area around the eye infection or inflammation.
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My blood vessel growth area is either larger than 3750 microns or smaller than 1000 microns.
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More than half of my eye lesion is covered by bleeding.
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I have a tear in the layer of my eye called the RPE.
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I am not allergic to anti-VEGF treatments or any topical medications.
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I have abnormal blood vessel growth not caused by AMD.
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I have had eye surgery, but only for cataract removal.
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I have switched my anti-VEGF medication in the last two doses.
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I am on blood thinners and my blood clotting tests are abnormal.
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I haven't had treatments other than anti-VEGF for my eye condition in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of the study intervention
Safety of the study intervention
Tolerability of the study intervention

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: episcleral brachytherapyExperimental Treatment1 Intervention
single fraction of 24 Gy Strontium90 episcleral brachytherapy

Find a Location

Who is running the clinical trial?

Salutaris Medical Devices, Inc.Lead Sponsor
1 Previous Clinical Trials
159 Total Patients Enrolled

Media Library

episcleral brachytherapy Clinical Trial Eligibility Overview. Trial Name: NCT02988895 — N/A
Age-Related Macular Degeneration Research Study Groups: episcleral brachytherapy
Age-Related Macular Degeneration Clinical Trial 2023: episcleral brachytherapy Highlights & Side Effects. Trial Name: NCT02988895 — N/A
episcleral brachytherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT02988895 — N/A
~1 spots leftby Dec 2025
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