June 2013
Volume 54, Issue 15
Free
ARVO Annual Meeting Abstract  |   June 2013
Comparison of Treatment Schedules in an Integrated Analysis of the VIEW Studies
Author Affiliations & Notes
  • Papp András
    Department of Ophthalmology, Semmelweis University Budapest, Budapest, Hungary
  • Bernd Sommerauer
    Bayer Healthcare, Berlin, Germany
  • Olaf Sowade
    Bayer Healthcare, Berlin, Germany
  • Footnotes
    Commercial Relationships Papp András, Allergan (C), Novartis (C), Bayer (F); Bernd Sommerauer, Bayer Pharma AG (E); Olaf Sowade, Bayer HealthCare AG (E)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2013, Vol.54, 6271. doi:
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      Papp András, Bernd Sommerauer, Olaf Sowade, ; Comparison of Treatment Schedules in an Integrated Analysis of the VIEW Studies. Invest. Ophthalmol. Vis. Sci. 2013;54(15):6271.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract
 
Purpose
 

To compare intravitreal aflibercept injection (IAI) treatment schedules by functional outcomes in an integrated analysis of the 2 phase 3 VIEW studies.

 
Methods
 

Patients with neovascular age-related macular degeneration (n=2412) were randomized to monthly ranibizumab 0.5 mg (Rq4), monthly IAI 2 mg (2q4), monthly IAI 0.5 mg (0.5q4), or IAI 2 mg every-other-month (2q8) following 3 initial monthly doses. The primary endpoint, proportion of patients losing <15 Early Treatment Diabetic Retinopathy Study letters, and key secondary endpoints were evaluated at Week 52. Between Weeks 52-96, injections were given at 12-week intervals, but could be given more frequently (up to every 4 weeks) if pre-specified criteria were met. Subgroup analyses were performed post-hoc.

 
Results
 

At both 52 and 96 weeks, treatment outcomes were similar for groups who received monthly or every-other-month treatment through Week 52 (Table). At 52 weeks, quartile analysis of visual acuity changes (<1, 1 to <6, 6 to <13, and ≥13 letters) showed comparable results for all dosing groups. At week 96, for all groups a slight, overall trend of vision loss was observed with reactive dosing (mean injections 4.1-4.7) compared to the results after 52-weeks of proactive dosing. During Weeks 52-96, visual acuity outcomes were maintained for the subgroup of patients who only received the 3 mandatory doses (~40-50% of patients in each dosing group). The incidence of ocular and systemic adverse events (AEs) was balanced across treatment groups in the overall population. The most frequent ocular AEs (>10% of patients) were conjunctival hemorrhage, eye pain, retinal hemorrhage, and reduced visual acuity.

 
Conclusions
 

These results show similar efficacy for monthly and every-other-month dosing with IAI across subgroups. Generally, a proactive treatment approach leads to more stable visual acuity results than reactive treatment.

  
Keywords: 412 age-related macular degeneration • 453 choroid: neovascularization • 466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials  
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