The primary objective is to assess long-term safety and tolerability of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD.
The dose evaluated in this study, Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg, will be the higher of the 2 dose strengths evaluated in parent study VGFT-OD-0605 (NCT00509795) and is the dose level administered in study VGFT-OD-0702 (NCT00527423), a long-term open-label extension study. For these reasons, this dose has been selected for this extension study. Participants will be seen in the clinic for quarterly visits starting with day 1 to assess safety. Study drug will be administered on an as-needed basis at the discretion of the investigator with a minimum allowed interval of every 4 weeks and a maximum allowed interval of every 12 weeks. This study will assess the frequency that re-treatment is needed and the effect of continued Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) treatment on BCVA.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
323
Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD
The primary endpoint in the study is the safety and tolerability of Intravitreal Aflibercept Injection in patients with neovascular AMD (Age-related Macular Degeneration) from day 1 through the end of treatment visit (week 180) based on the number of participants who experienced any treatment-emergent adverse event (TEAE). Treatment-emergent adverse events were categorized according to Ocular TEAEs in the study eye, Ocular TEAEs in the fellow eye, and Non-Ocular TEAEs
Time frame: Baseline (day 1) through end of treatment (Week 180)
Change in BCVA Letter Score (mLOCF)
The secondary endpoint in the study is the change in BCVA letter score from baseline through Week 116. (mLOCF: The last non-missing observation prior to the missing visit was carried forward to impute the missing data; no imputation after last visit; no baseline value carried forward).
Time frame: Baseline through Week 116
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Birmingham (2 Locations), Alabama, United States
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Phoenix (2 Locations), Arizona, United States
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Tucson (2 Locations), Arizona, United States
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Arcadia, California, United States
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Beverly Hills, California, United States
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Campbell, California, United States
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Fresno, California, United States
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Fullerton, California, United States
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La Jolla, California, United States
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Loma Linda, California, United States
...and 114 more locations