Episcleral Brachytherapy for the Treatment of Wet AMD

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 20
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Salutaris Medical Devices, Inc.
• Last Updated: 2017-08-01

Criteria

Inclusion Criteria:

• Diagnosis of CNV due to nAMD

• Male or female aged 50 years or older

• Documented continued care for nAMD since diagnosis

• 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 CNV as determined by FA

• 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:

• Females of child-bearing potential (defined as < 2 years post-menopausal)

• CNV other than due to nAMD

• Sub-foveal lesion hemorrhage obscuring >50% of lesion

• CNV lesion with greatest linear dimension >2mm as determined by Intravenous Fluorescein angiography

• Presence of subretinal fibrosis 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

• 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

• Unable to discontinue anticoagulation or dual anti-platelet therapy for 7 days before and after the study intervention.

• 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

• Only eligible eye is the best seeing 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