Episcleral Brachytherapy for the Treatment of Wet AMD (NEAMES)

August 28, 2023 updated by: Salutaris Medical Devices, Inc.

A Prospective Study of Episcleral Brachytherapy for the Treatment of Neovascular Age-related Macular Degeneration

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Subjects will receive a single brachytherapy treatment and 36 months of follow-up.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Retina Consultants Of Hawaii
    • Illinois
      • Oak Forest, Illinois, United States, 60452
        • University Retina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of active CNV or PCV due to nAMD
  • Poor or non-responsive to FDA approved intravitreal anti-VEGF therapy for nAMD
  • BCVA 20/63 or worse Snellen equivalent in the study eye
  • Ability to understand nature/purpose of trial and to provide informed consent
  • Ability to undergo diagnostic tests and surgical interventions
  • Ability to follow instructions and complete the trial including all scheduled visits and follow-up

Exclusion Criteria:

  • Neovascularization other than due to AMD
  • Sub-foveal lesion hemorrhage obscuring >50% of lesion
  • Targeted neovascular lesion with greatest linear dimension >3750 microns or <1000 microns as determined by angiography
  • Presence of subretinal fibrosis, including disciform scar, or retinal pigment epithelial (RPE) atrophy that is extensive or foveal threatening in the study eye
  • An existing retinal pigment epithelial (RPE) tear
  • Previous treatment (excluding vitamins) for nAMD in the study eye other than anti-VEGF therapy in the last 6 months
  • A change in anti-VEGF agent in the previous two administrations
  • Anticipate a change to the anti-VEGF agent during the conduct of the study
  • Other clinically significant ocular co-morbidity including, but not limited to, glaucoma, optic neuropathy of any cause, maculopathy / retinopathy of any cause other than nAMD, scleritis, enophthalmos, microphthalmia, or other co-morbidities that in the investigator's opinion could require medical or surgical intervention to prevent or treat visual loss or media opacity that might result from that condition (i.e. severe cataracts).
  • Previous intraocular surgery in study eye other than for uncomplicated phacoemulsification cataract extraction
  • High myopia indicated by a history of refractive error of - 6D or greater (spherical equivalent), demonstrated myopic degeneration, or axial length of >26.5mm.
  • Subjects with orbital structural abnormalities, such as small (axial length <21 mm), deep set globes or other globe dystopias that, in the investigator's clinical judgment, would require a change in the angle of insertion or increase the risk of structural damage from retrobulbar anesthesia, sub-Tenon's anesthesia, or retrobulbar device positioning.
  • Media opacity sufficient to preclude adequate fundoscopy, OCT, or angiography
  • Uncontrolled systemic diseases (e.g. controlled hypertension is acceptable)
  • Type I or type II diabetes mellitus
  • Any previous therapeutic radiation to the head or neck or other areas that may have resulted in a radiation dose to the retina.
  • On anticoagulation or dual anti-platelet therapy with abnormal coagulation panel results.
  • Patient unsuitable for IV or local anesthesia
  • Any contraindication to anti-VEGF, fluorescein, indocyanine green, topical and local anesthetics, topical antiseptics, or topical antibiotics to be used during the study
  • Active ocular or periocular infection or intraocular inflammation
  • Fellow eye with a BCVA of 20/63 Snellen Equivalent or worse, with advanced AMD (neovascular or non-exudative AMD with foveal geographic atrophy), or other vision threatening disease that is not eligible for vision restoring treatment (i.e. inoperable cataracts).
  • Fellow eye is receiving anti-VEGF therapy
  • Have received any investigational treatment for any indication in the previous 30 days
  • Any condition which, in the investigators' opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule or other study conduct

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: episcleral brachytherapy
single fraction of 24 Gy Strontium90 episcleral brachytherapy
Radiation: episcleral brachytherapy
The study intervention is an outpatient, ambulatory procedure performed under local anesthesia with anesthesia assist.
Other Names:
  • Strontium 90

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of the study intervention
Time Frame: 26 weeks
Adverse event assessment
26 weeks
Tolerability of the study intervention
Time Frame: During procedure
Subject pain score during procedure
During procedure
Feasibility of the study intervention
Time Frame: 1 day
Investigator ability to place the device and deliver a therapeutic dose
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salutaris Medical Devices, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

May 26, 2023

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

December 6, 2016

First Submitted That Met QC Criteria

December 7, 2016

First Posted (Estimated)

December 9, 2016

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMD-201601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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