The study will investigate the safety and feasibility of using the TheraSight(TM) Brachytherapy System for treatment of wet age-related macular degeneration (AMD).
This is a multi-center randomized study of three doses of radiation (assigned 1:1:1) delivered by the TheraSight(TM) Brachytherapy System in participants with choroidal neovascularization (CNV) secondary to wet (exudative) AMD. Each participant receives a single dose of radiation delivered by one-time only brachytherapy. Participants are followed for three years after the radiation treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Theragenics Clinical Site
Atlanta, Georgia, United States
RECRUITINGTheragenics Clinical Site
Augusta, Georgia, United States
RECRUITINGTheragenics Clinical Site
Indianapolis, Indiana, United States
Incidence of serious adverse events 30 to 270 days after treatment
Serious adverse events occurring 9 months to 3 years after treatment
Reported adverse events occurring at any time after treatment
Feasibility of device use based on physician interviews and ultrasonography
Observation of retinal and angiographic appearance of CNV lesion and best-corrected visual acuity
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Theragenics Clinical Site
Boston, Massachusetts, United States
RECRUITINGTheragenics Clinical Site
Newark, New Jersey, United States
RECRUITINGTheragenics Clinical Site
Raleigh / Durham, North Carolina, United States
RECRUITING