The purpose of this study is to confirm the safety and establish the effectiveness of two doses from the IRay System for the treatment of wet AMD.
The purpose of this study is to confirm the safety of low voltage external beam radiotherapy using the IRay System at two dose levels for the treatment of CNV secondary to neovascular AMD and to determine if the IRay System is effective in sparing the number of Lucentis injections during the first 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
230
Low voltage stereotactic radiotherapy system
LKH Graz
Graz, Austria
Universitätsklinik Innsbruck
Innsbruck, Austria
Number of Lucentis® Injections Up To And Including Week 52
Time frame: During the first 52 weeks.
Change in Mean Visual Acuity (VA)
Time frame: Weeks 12, 28, 52 and 104.
Percentage (Pct.) of Patients (Pts.) Losing < 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)
Time frame: Weeks 12, 28 and 52.
Percentage (Pct.) of Patients (Pts.) Gaining ≥ 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)
Time frame: Weeks 12, 28 and 52.
Percentage (Pct.) of Patients (Pts.) Gaining ≥ 0 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)
Time frame: Weeks 12, 28 and 52.
Time From Mandatory Injection at Day 0 to the First PRN Injection.
Time frame: 52 Weeks
Total Number (No.) of Lucentis® Injections (Inject.) During The First 12, 28, and 104 Weeks.
Time frame: Week 12, 28, and 104
Mean Change in Choroidal Neovascularization (CNV) as % of Lesion on Fluorescein Angiography (FA) From Baseline to Week 52
Time frame: Week 52
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Ordination Prof. Michael Stur
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