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Episcleral Brachytherapy for the Treatment of Wet AMD (NEAMES)

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ClinicalTrials.gov Identifier: NCT02988895
Recruitment Status : Recruiting
First Posted : December 9, 2016
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Salutaris Medical Devices, Inc.

Brief Summary:
This is a prospective, single-arm, open-label, safety, usability and tolerability trial of Strontium 90 (Sr90) beta radiation episcleral brachytherapy in subjects receiving aflibercept therapy pro re nata (PRN) for the treatment of early neovascular Age-related Macular Degeneration (nAMD) lesions. Secondary aims are to observe clinical outcomes of area of leakage, sub-retinal fluid, lesion size, visual acuity, and anti-vascular endothelial growth factor (anti-VEGF) treatment burden.

Condition or disease Intervention/treatment Phase
Macular Degeneration, Choroidal Neovascularization Radiation: episcleral brachytherapy Drug: Anti-VEGF Phase 2

Detailed Description:
Subjects will receive a single brachytherapy treatment and 52-weeks of follow-up.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 2018
Estimated Study Completion Date : October 2019

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

Drug: Anti-VEGF
Administered PRN as Standard of Care




Primary Outcome Measures :
  1. Safety of the study intervention [ Time Frame: 12 weeks ]
    Adverse Event assessment


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

  2. Change from baseline in area of leakage [ Time Frame: 12-weeks, 52-weeks ]
  3. Change from baseline in sub-retinal fluid volume [ Time Frame: 12-weeks, 52-weeks ]
  4. Change from baseline maximum choroidal neovascular (CNV) lesion size (thickness) [ Time Frame: 12 weeks, 52 weeks ]
  5. Number of PRN anti-VEGF administrations [ Time Frame: 52 weeks ]
  6. Change from baseline Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BVCA) [ Time Frame: 12 weeks, 52 weeks ]
  7. Adverse Events [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

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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 CNV or PCV due to nAMD by angiography
  • Male or female aged 50 years or older
  • Documentation of prior treatment for nAMD
  • Patients must have demonstrated clinical or OCT/angiographic evidence that, in the investigator's opinion, requires treatment with anti-VEGF therapy.
  • BCVA 20/40 - 20/200 Snellen equivalent in study eye
  • Actively leaking neovascular complex as determined by angiography
  • 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:

  • Women who are pregnant or plan to become pregnant during the study
  • CNV other than due to nAMD
  • Sub-foveal lesion hemorrhage obscuring >50% of lesion
  • CNV lesion with greatest linear dimension >3750 microns as determined by angiography
  • Presence of subretinal fibrosis or retinal pigment epithelial atrophy involving the central macula in the study eye
  • Existing Retinal Pigment Epithelial tear
  • Previous treatment (excluding vitamins) for nAMD in the study eye other than aflibercept 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
  • Previous intraocular surgery in study eye other than for uncomplicated phacoemulsification cataract extraction
  • Other clinically significant ocular co-morbidity including, but not limited to, optic glaucoma, optic neuropathy of any cause, maculopathy / retinopathy of any cause other than nAMD, and scleritis
  • History of refractive error of - 6D or greater (spherical equivalent) or demonstrated myopic degeneration
  • 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
  • Clinically significant previous radiation to the eye
  • 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, 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 worse visual acuity than the study eye.
  • 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
Contact: Mary Drew, MS 520-638-7518 mdrew@salutarismd.com
Contact: Hailey Davenport, BS 520-638-7518 hdavenport@salutarismd.com

Locations
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.

Responsible Party: Salutaris Medical Devices, Inc.
ClinicalTrials.gov Identifier: NCT02988895     History of Changes
Other Study ID Numbers: SMD-201601
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases