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NEAMES: Episcleral Brachytherapy for the Treatment of Wet AMD

Sponsor
Salutaris Medical Devices, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02988895
Collaborator
(none)
12
Enrollment
2
Locations
1
Arm
64
Anticipated Duration (Months)
6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: episcleral brachytherapy
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective Study of Episcleral Brachytherapy for the Treatment of Neovascular Age-related Macular Degeneration
Actual Study Start Date :
Aug 1, 2017
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety of the study intervention [26 weeks]

      Adverse event assessment

    2. Tolerability of the study intervention [During procedure]

      Subject pain score during procedure

    3. Feasibility of the study intervention [1 day]

      Investigator ability to place the device and deliver a therapeutic dose

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Retina Consultants of Hawaii 'Aiea Hawaii United States 96701
    2 University Retina Oak Forest Illinois United States 60452

    Sponsors and Collaborators

    • Salutaris Medical Devices, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Salutaris Medical Devices, Inc.
    ClinicalTrials.gov Identifier:
    NCT02988895
    Other Study ID Numbers:
    • SMD-201601
    First Posted:
    Dec 9, 2016
    Last Update Posted:
    Feb 15, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Salutaris Medical Devices, Inc.
    Brachytherapy
    Wet AMD
    Additional relevant MeSH terms:
    Macular Degeneration
    Choroidal Neovascularization
    Neovascularization, Pathologic

    Study Results

    No Results Posted as of Feb 15, 2022