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Trial record 1 of 1 for:    episcleral brachytherapy
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Episcleral Brachytherapy for the Treatment of Wet AMD (NEAMES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02988895
Recruitment Status : Recruiting
First Posted : December 9, 2016
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Salutaris Medical Devices, Inc.

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
Macular Degeneration, Choroidal Neovascularization Radiation: episcleral brachytherapy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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 : August 1, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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 Name: Strontium 90




Primary Outcome Measures :
  1. Safety of the study intervention [ Time Frame: 26 weeks ]
    Adverse event assessment

  2. Tolerability of the study intervention [ Time Frame: During procedure ]
    Subject pain score during procedure

  3. Feasibility of the study intervention [ Time Frame: 1 day ]
    Investigator ability to place the device and deliver a therapeutic dose



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988895


Contacts
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Contact: Mary Drew, MS 520-638-7518 mdrew@salutarismd.com
Contact: Hailey Davenport, BS 520-638-7518 hdavenport@salutarismd.com

Locations
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United States, Hawaii
Retina Consultants of Hawaii Recruiting
'Aiea, Hawaii, United States, 96701
Contact: Sheila Chamian    808-380-8060    sheila@retinahi.com   
Principal Investigator: Gregg Kokame, MD         
United States, Illinois
University Retina Recruiting
Oak Forest, Illinois, United States, 60452
Contact: Breanne Kirby         
Contact    (708)687-2222    bkirby@uretina.com   
Principal Investigator: Rama Jager, M.D.         
Sponsors and Collaborators
Salutaris Medical Devices, Inc.

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Responsible Party: Salutaris Medical Devices, Inc.
ClinicalTrials.gov Identifier: NCT02988895    
Other Study ID Numbers: SMD-201601
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Macular Degeneration
Choroidal Neovascularization
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases