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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during procedure
Awards & highlights
NEAMES Trial 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.Check my eligibility
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.See study design
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.
NEAMES Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with wet age-related macular degeneration.
Select...
My eye condition didn't improve with specific eye injections.
Select...
I understand the trial's purpose and can give informed consent.
NEAMES Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of the study intervention
Safety of the study intervention
Tolerability of the study intervention
NEAMES 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
1 Trials studying Macular Degeneration
159 Patients Enrolled for Macular Degeneration
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My other eye is being treated with anti-VEGF medication.My blood vessel growth area is either larger than 3750 microns or smaller than 1000 microns.My eye condition didn't improve with specific eye injections.My other eye has severe vision loss due to AMD or another untreatable condition.I have been diagnosed with wet age-related macular degeneration.My eye has scar tissue or damage in the retina that threatens my central vision.I expect to switch to a different anti-VEGF treatment during the study.I have had radiation therapy to my head, neck, or eyes.I have an eye or area around the eye infection or inflammation.I am able to have tests and surgeries.I can follow all trial instructions and attend every scheduled visit.More than half of my eye lesion is covered by bleeding.I understand the trial's purpose and can give informed consent.I have a tear in the layer of my eye called the RPE.I am not allergic to anti-VEGF treatments or any topical medications.I have abnormal blood vessel growth not caused by AMD.My other health conditions are under control, except for high blood pressure which is managed.I have had eye surgery, but only for cataract removal.I have switched my anti-VEGF medication in the last two doses.I am on blood thinners and my blood clotting tests are abnormal.I haven't had treatments other than anti-VEGF for my eye condition in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: episcleral brachytherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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