The objective of this clinical study is to evaluate the safety and feasibility of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) in patients with age related macular degeneration that have failed Primary Anti-VEGF therapy.
Therapeutic advances in the arena of neovascular age-related macular degeneration (AMD) have provided multiple treatment options for the disease. Radiotherapy has been studied in multiple clinical trials in the past with many studies showing a therapeutic benefit. Treatment with radiotherapy and anti-VEGF compounds is a promising approach to treating AMD.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
A single procedure using the NeoVioasta Ophthalmic System plus an injection of Lucentis.
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Safety Parameters to be evaluated include incidence and severity of ocular adverse events identified by eye examinations, including visual acuity. Retinal thickness will also be measured, and stereo fundus photography will be reviewed.
Time frame: 3 Year
Efficacy Assessment: Preliminary efficacy will be evaluated by measuring best-corrected visual acuity (ETDRS) and AMD lesion size and leakage as assessed by fluorescein angiography at 1, 2, 3, 6, 12, 18, 24, and 36 months in the study eye.
Time frame: 3 Years
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