The objective of the MERITAGE Trial is to evaluate the safety and efficacy of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) associated with wet age-related macular degeneration (AMD) in patients that require persistent injections of Anti-VEGF therapy to maintain an adequate response to treatment.
Therapeutic advances in the arena of neovascular age-related macular degeneration (AMD) have provided multiple treatment options for the disease. Brachytherapy 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. The current treatment for neovascualar AMD involves multiple injections over an indefinite period of time. This trial will evaluate whether treatment with brachytherapy can reduce or eliminate the need for continued injections.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
A single procedure with the NeoVista Ophthalmic System, with Lucentis (0.5mg) administered on an as needed basis for three years.
Retina Consultants of Arizona
Phoenix, Arizona, United States
Retinal Institute of Hawaii
Honolulu, Hawaii, United States
Rabin Medical Center
Petah Tikva, Israel
Tel-Aviv Medical Center
Tel Aviv, Israel
Number of re-treatment injections of anti-VEGF (Lucentis) therapy
Time frame: 3 years
Percentage of subjects losing less than 15 ETDRS letters
Time frame: 3 years
Safety Assessment: Incidence and severity of averse events and ocular AEs. Incidence of cataract changes. Incidence of radiation induced toxicity
Time frame: 3 years
Percentage of subjects gaining ≥ 15 ETDRS Letters
Time frame: 3 years
Percentage of subject gaining ≥0 ETDRS letters
Time frame: 3 years
Mean change in ETDRS visual acuity
Time frame: 3 years
Change in total lesion size and CNV size by fluorescein angiography
Time frame: 3 years
Foveal thickness measured using OCT.
Time frame: 3 years
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Kings College Hospital
London, United Kingdom