Episcleral Brachytherapy for the Treatment of Wet AMD

Not Applicable

Active, not recruiting

• Conditions: Macular Degeneration, Choroidal Neovascularization
• Interventions: Radiation: episcleral brachytherapy

• Registration Number: NCT02988895
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-07
• Study First Posted: 2016-12-09
• Study Start: 2017-08-01
• Primary Completion: 2023-05-26
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
episcleral brachytherapy	episcleral brachytherapy	single fraction of 24 Gy Strontium90 episcleral brachytherapy

Primary Outcome Measures

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

Trial Locations

Locations (2)

University Retina; 🇺🇸 Oak Forest, Illinois, United States

Retina Consultants of Hawaii; 🇺🇸 'Aiea, Hawaii, United States