To assess the efficacy of intravitreal (IVT) administration of aflibercept with two different approaches of Treat and Extend dosing regimens in Japanese subjects with neovascular (wet) Age-related Macular Degeneration (wAMD) . To assess the safety of IVT administration of aflibercept with two different approaches of Treat and Extend dosing regimen in Japanese subjects with wAMD for up to 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
288
Aflibercept 2mg is intravitreally injected.
Mean Change From Baseline in BCVA at Week 52
Visual functions of the study eye (at every visit) and the fellow eye were assessed, according to the ETDRS protocol as described in detail in the operation manual. A higher score represents better functioning.
Time frame: Baseline and Week 52
Percentage of Participants Who Maintained Vision at Week 52
A participant was classified as maintaining vision if the participant had lost fewer than 15 letters in the ETDRS letter score compared to baseline.
Time frame: Week 52
Percentage of Participants Who Gained at Least 15 Letters of Vision Compared to Baseline at Week 52
Time frame: Baseline and Week 52
Mean Change in Central Retinal Thickness (CRT) From Baseline at Week 52
Time frame: Baseline and week 52
Percentage of Participants Without Fluid on Optical Coherence Tomography (OCT) at Week 52
A participant was classified as without fluid if "Evidence of new or persistent fluid" on OCT was "No".
Time frame: Week 52
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Unnamed facility
Ichinomiya, Aichi-ken, Japan
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Toyoake, Aichi-ken, Japan
Unnamed facility
Asahi, Chiba, Japan
Unnamed facility
Sakura, Chiba, Japan
Unnamed facility
Kōriyama, Fukushima, Japan
Unnamed facility
Kure, Hiroshima, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
...and 31 more locations