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Xiaoxin Li, Youxin Chen, JunJun Zhang, Xun Xu, Gemmy Cheung, Helen Wu, Rae Yu, Husain Kazmi, Olaf Sowade, Oliver Zeitz; Intravitreal aflibercept shows consistent outcomes in Asian and white patients with wet age-related macular degeneration: novel results from the SIGHT and VIEW studies. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1658.
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© ARVO (1962-2015); The Authors (2016-present)
Intravitreal aflibercept injection (IAI) was approved for use in wet age-related macular degeneration (wAMD) in 70 countries based on the pivotal VIEW studies. We present 28-week outcomes from wAMD patients enrolled in VIEW 1 (US/Canada), VIEW 2 (global), and SIGHT (predominantly classic choroidal neovascularization [CNV] patients in China). The analysis is novel as it compares predominantly classic CNV subgroups across studies and presents other CNV subgroups in VIEW.
Patients with CNV secondary to wAMD who were randomized to IAI 2.0 mg every 8 weeks after 3 initial monthly doses (2q8) in the integrated VIEW studies or SIGHT were included. The analyzed efficacy endpoints included the mean change in best-corrected visual acuity (BCVA) from baseline to Week 28, the proportion of patients who lost <15 or gained ≥15 (exploratory) ETDRS letters at Week 28 compared to baseline, and mean change in central retinal thickness (CRT) from baseline to Week 28. Treatment-emergent adverse events (TEAEs) were analyzed as well.
580 patients (with evaluable subgroup data) from integrated VIEW (n=507 [white] and n=73 [Asian]) and 219 patients from SIGHT were included in this analysis. The mean age (years) was 76.8 (white VIEW), 68.9 (Asian VIEW), and 65.0 (SIGHT). Clinically meaningful improvements were observed in both BCVA (letters) and CRT at Week 28 regardless of race or CNV subtype (Table 1). In the predominantly classic CNV subgroup, the most common ocular TEAE (study eye) was conjunctival hemorrhage (24.4% [white VIEW], 11.1% [Asia VIEW], and 5.9% [SIGHT]), and Antiplatelet Trialists’ Collaboration-defined arterial thromboembolic events occurred in 1.5% (white VIEW), 0.0% (Asia VIEW), and 0.5% (SIGHT).
The efficacy and safety of IAI 2q8 was consistent between the integrated VIEW and SIGHT studies after 28 weeks of treatment, and effectiveness was evidenced across ethnicity and CNV subtypes. Asian patients with the predominantly classic wAMD subtype tended to have a better response, with numerically greater visual and morphologic improvements. This might be caused by the lower mean age of the SIGHT and Asian VIEW populations compared to the white VIEW population.
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