Episcleral Brachytherapy for the Treatment of Wet AMD (NEAMES)

S

Salutaris Medical Devices

Status

Active, not recruiting

Conditions

Macular Degeneration, Choroidal Neovascularization

Treatments

Radiation: episcleral brachytherapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT02988895
SMD-201601

Details and patient eligibility

About

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.

Full description

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

Enrollment

11 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

11 participants in 1 patient group

episcleral brachytherapy
Experimental group
Description:
single fraction of 24 Gy Strontium90 episcleral brachytherapy
Treatment:
Radiation: episcleral brachytherapy

Trial contacts and locations

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Central trial contact

Hailey Davenport, BS; Mary Drew, MS

Data sourced from clinicaltrials.gov

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