June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Results of intravitreal aflibercept in patients with neovascular age-related macular degeneration, without optimal response to anti VEGF-A therapy. MACBETH STUDY
Author Affiliations & Notes
  • Marc Biarnes Perez
    Institut de la màcula, Barcelona, Spain
    Barcelona Macula Foundation, Barcelona, Spain
  • Jordi Monés
    Institut de la màcula, Barcelona, Spain
    Barcelona Macula Foundation, Barcelona, Spain
  • Footnotes
    Commercial Relationships   Marc Biarnes Perez, Bayer (R); Jordi Monés, Alcon (C), Alcon (R), Alcon (F), Allergan (C), Bayer (C), Bayer (R), Bayer (F), Genentech (C), Genentech (R), Notal Vision (C), Notal Vision (I), Novartis (R), Novartis Pharma (C), Ophthotech (C), Ophthotech (R), Ophthotech (F), Ophthotech (I), Roche (C), Roche (R)
  • Footnotes
    Support  Bayer
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 878. doi:
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      Marc Biarnes Perez, Jordi Monés; Results of intravitreal aflibercept in patients with neovascular age-related macular degeneration, without optimal response to anti VEGF-A therapy. MACBETH STUDY. Invest. Ophthalmol. Vis. Sci. 2017;58(8):878.

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

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Abstract

Purpose : To assess the efficacy of intravitreal aflibercept in patients with neovascular age-related macular degeneration (nAMD) without optimal response to previous intravitreal injections of anti-VEGF A therapy.

Methods : Forty weeks, single arm, multicenter, phase IV study. Patients ≥50 years with nAMD, best-corrected visual acuity (BCVA) between 20/32 and 20/320 and suboptimal response to treatment with ranibizumab or bevacizumab (defined as patients with significant persistent or recurrent fluid) were included. The primary efficacy endpoint was to determine the percentage of eyes without intra or subretinal fluid on optical coherence tomography (OCT) after 3-monthly loading doses of aflibercept at week 12. Secondary endpoints were mean BCVA and central macular thickness (CMT) change at weeks 12 and 40, and percentage of eyes without fluid at week 40.

Results : Sixty patients were screened and 46 (76.7%) were included in the intention-to-treat population. The mean [standard deviation, SD] age was 77.1 [8.7] years, 50% were female and 97.8% Caucasian. At week 12 (n=46), 45.7% (95% CI: 31.5-60.1%) of eyes showed no fluid on OCT. The mean [SD] BCVA increased from 65.1 [8.3] to 69.6 [8.1] letters (+4.5 [5.8], p<0.0001), and was stabilized at week 40 (n=44), the last visit (67.2 [11.0] letters; +1.8 [8.4], p=0.17). Mean CMT decreased from 430 [119] mm at baseline to 323 [100] mm at week 12 (-107 [90] mm, p<0.0001), and was also reduced at week 40 (377 [121] mm; -46 [111] mm, p=0.0056). At week 40, the percentage of eyes without fluid was 21.7%. There was one case of endophthalmitis, which was presumably not infectious and responded to treatment.

Conclusions : After 3 monthly doses of aflibercept, almost half of patients had no fluid on OCT, and a clinically significant improvement of BCVA and CMT was observed. At week 40, one in five patients did not show intra or subretinal fluid, CMT decreased and BCVA stabilized as compared to baseline, with an acceptable safety profile.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

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