To collect data reflecting the efficacy and safety of aflibercept with and without photodynamic therapy in subjects diagnosed with the polypoidal choroidal vasculopathy subtype of wet age-related macular degeneration
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
333
Eylea is administered as an intravitreal injection
Photodynamic therapy is a combined therapy of drug (Visudyne) applied to reinforce the action of a device (laser)
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) Letter Scores From Baseline to Week 52 - Last Observation Carried Forward (LOCF)
Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.
Time frame: From Baseline to Week 52
Percentage of Subjects Who Avoided at Least 15 Letters Loss in ETDRS at Week 52
Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.
Time frame: At Week 52
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Liverpool, New South Wales, Australia
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Strathfield, New South Wales, Australia
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Westmead, New South Wales, Australia
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East Melbourne, Victoria, Australia
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Parramatta, Australia
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München, Germany
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Hong Kong, Hong Kong
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Kowloon, Hong Kong
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Budapest, Hungary
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Budapest, Hungary
...and 52 more locations