June 2015
Volume 56, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2015
Intravitreal aflibercept shows consistent outcomes in Asian and white patients with wet age-related macular degeneration: novel results from the SIGHT and VIEW studies
Author Affiliations & Notes
  • Xiaoxin Li
    People's Eye Center, People's Hospital, Peking University, Beijing, China
  • Youxin Chen
    No. 1 Shuai Fuyuan, Beijing, China
  • JunJun Zhang
    No. 37 Guoxue Alley, Chengdu, China
  • Xun Xu
    No. 100 Haining Road, Shanghai, China
  • Gemmy Cheung
    Singapore Eye Research Institute, Singapore, Singapore
  • Helen Wu
    Bayer HealthCare Inc., Beijing, China
  • Rae Yu
    Bayer HealthCare Inc., Beijing, China
  • Husain Kazmi
    Regeneron Pharmaceuticals Inc., New York, NY
  • Olaf Sowade
    Bayer Pharma AG, Berlin, Germany
  • Oliver Zeitz
    Bayer Pharma AG, Berlin, Germany
  • Footnotes
    Commercial Relationships Xiaoxin Li, Bayer (C); Youxin Chen, Bayer (C); JunJun Zhang, Bayer (C); Xun Xu, Bayer (C); Gemmy Cheung, Bayer (C); Helen Wu, Bayer (E); Rae Yu, Bayer (E); Husain Kazmi, Regeneron (E); Olaf Sowade, Bayer (E); Oliver Zeitz, Bayer (E)
  • Footnotes
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Investigative Ophthalmology & Visual Science June 2015, Vol.56, 1658. doi:
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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)

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Abstract
 
Purpose
 

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.

 
Methods
 

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.

 
Results
 

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).

 
Conclusions
 

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.  

 
Table 1: Mean visual and anatomic changes from baseline to Week 28 in VIEW and SIGHT subgroups
 
Table 1: Mean visual and anatomic changes from baseline to Week 28 in VIEW and SIGHT subgroups

 
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