Episcleral Brachytherapy for Wet Age-Related Macular Degeneration

(NEAMES Trial)

Not currently recruiting at 2 trial locations

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

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with wet age-related macular degeneration (AMD) who haven't responded to anti-VEGF therapy. It uses a device called the SalutarisMD SMD-DA system, which delivers radiation therapy directly to the eye in a single session. The trial aims to determine the safety and feasibility of this treatment. Suitable candidates include those with active eye conditions from AMD who haven't improved with current eye injections. As an unphased trial, it offers patients the chance to explore innovative treatments that may offer new hope for managing their condition.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it mentions that no changes to the standard of care are required during the follow-up period. It's best to discuss your specific medications with the trial team.

What prior data suggests that the SalutarisMD SMD-DA system is safe for episcleral brachytherapy?

Research has shown that the SalutarisMD SMD-DA system, used for episcleral brachytherapy, is generally well-tolerated by patients. In one study, the procedure proceeded without any problems, and patients managed it well. This treatment involves a single session where radiation is applied directly to the eye area.

While detailed safety information remains limited, available studies mainly focus on the system's safety and practicality. Since this treatment is being tested in a study focused on safety, researchers are carefully monitoring patient reactions.

For those considering joining the trial, it is important to know that safety is a top priority, and any risks are thoroughly evaluated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for wet age-related macular degeneration, which often involve repeated injections into the eye, the SalutarisMD SMD-DA system delivers a single fraction of 24 Gy Strontium90 episcleral brachytherapy. This method is unique because it uses a precise radiation technique applied directly to the outside of the eye, potentially reducing the need for frequent treatments. Researchers are excited about this approach because it could provide a more convenient and less invasive alternative to current therapies, while still effectively targeting the abnormal blood vessels responsible for the condition.

What evidence suggests that the SalutarisMD SMD-DA system is effective for wet age-related macular degeneration?

Research has shown that episcleral brachytherapy using the SalutarisMD SMD-DA system, which participants in this trial will receive, may be a promising treatment for wet age-related macular degeneration (wet AMD). Studies have found this treatment effective for a type of wet AMD that mostly affects people with lighter skin. Data shared at medical meetings indicated that patients who received this therapy experienced improved vision. The treatment delivers focused radiation directly to the affected part of the eye, helping to manage the condition. Early results suggest it could be a good option for patients who haven't responded to other treatments like anti-VEGF therapy. ^{1 2 3 6 7}

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single fraction of 24 Gy Strontium90 episcleral brachytherapy

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02988895

Episcleral Brachytherapy for the Treatment of Wet AMD This is a prospective, multi-site, safety and feasibility study of the SalutarisMD SMD-DA system for retrobulbar minimally invasive episcleral brachytherapy ...

2. biospace.com biospace.com/b-salutarismd-b-presents-data-for-promising-device-to-treat-wet-amd-at-b-astro-b-annual-meeting

SalutarisMD Presents Data for Promising Device to Treat ... SalutarisMD Presents Data for Promising Device to Treat Wet AMD at ASTRO Annual Meeting ... Which Weight Loss Treatments Will Be Most Effective?

3. salutarismd.com salutarismd.com/

SalutarisMD - Saving Vision For Everyone Effective against classic wet-AMD, the type that primarily affects lightly pigmented individuals, especially Whites. · Improvement in vision is palliative due to ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35713709/

Two-year outcomes of episcleral brachytherapy adjunct to ... Purpose: This study was designed to demonstrate the safety and feasibility of episcleral brachytherapy (ESB) for the treatment of anti-vascular ...

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT02988895?keyword=%22Wet%20AMD%22

Episcleral Brachytherapy for the Treatment of Wet AMD This is a prospective, multi-site, safety and feasibility study of the SalutarisMD SMD-DA system for retrobulbar minimally invasive episcleral brachytherapy ...

6. azbio.org azbio.org/salutaris-medical-devices-inc-announces-first-subject-treated-in-a-clinical-trial-investigating-the-smd-da-ophthalmic-device-for-the-treatment-of-neovascular-age-related-macular-degeneration-namd

Salutaris Medical Devices, Inc. announces first subject ... The procedure was performed without complication and well tolerated by the subject. The trial, “A Prospective Study of Episcleral Brachytherapy ...

7. researchgate.net researchgate.net/publication/228112225_SU-E-T-308_Dosimetry_of_a_New_Minimally_Invasive_Episcleral_Brachytherapy_Device

Dosimetry of a New Minimally Invasive Episcleral Brachytherapy ... ... A novel episcleral brachytherapy device has been introduced by Salutaris Medical Devices, Inc. (SalutarisMD) to treat wet AMD with an accurate therapeutic ...