The purpose of this study is to confirm the clinical and economic benefits of IRay treatment with respect to the number of anti-VEGF injections and frequency of visits during the first year after treatment for patients with wet Age-related Macular Degeneration (AMD).
The objective of this study is to confirm the clinical and economic benefits of low voltage external beam radiotherapy with the IRay with respect to number of anti-VEGF injections and frequency of ophthalmic assessments during the one year interval following treatment in subjects with neovascular AMD.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Approved dose of Anti-VEGF injection given at Day 0 followed by treatment with 16 Gy dose of IRay up to 14 days later.
Manchester Royal Eye Hospital
Manchester, United Kingdom
RECRUITINGRate of anti-VEGF injections during the first 12 months
Time frame: 12 Months
Time to first Anti-VEGF injection
Time frame: Up to Month 12
Change in mean best-corrected visual acuity in the treated eye at month 12
Time frame: Month 12
Visual Functioning Questionnaire - 25 (VFQ-25)
Time frame: Baseline & Month 12
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