title: Intravitreal aflibercept for treatment-resistant neovascular age-related macular degeneration.
abstract: OBJECTIVE
  To assess the effectiveness of intravitreal aflibercept in patients with neovascular age-related macular degeneration (AMD) previously resistant to treatment with other anti-vascular endothelial growth factor agents.
  
  
  METHODS
  Prospective, open-label, noncontrolled, registered clinical trial.
  
  
  METHODS
  Forty-nine patients with treatment-resistant neovascular AMD.
  
  
  METHODS
  A dose of 2 mg intravitreal aflibercept was administered as 3 initial loading doses every 4 weeks (week 0, week 4, and week 8), followed by further injections every 8 weeks (weeks 16 and 24) across a 24-week period in total. All patients underwent a complete ophthalmic examination, including measurement of Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA), intraocular pressure assessment, adverse event monitoring, and spectral-domain optical coherence tomography at every visit. Baseline fluorescein angiography and indocyanine green angiography also were performed.
  
  
  METHODS
  Outcomes assessed included proportions of patients with a gain or loss of more than 5 ETDRS letters and a decrease or increase in central retinal thickness (CRT) of more than 150 μm at week 24 compared with baseline, change in mean BCVA and CRT between baseline and week 24, and descriptive safety data.
  
  
  RESULTS
  The BCVA improved and CRT was reduced significantly at all follow-up visits compared with baseline (P < 0.001), with a mean improvement of 6.9 letters of BCVA and a decrease of 89.4 μm in CRT at week 24. Spacing of injections from every 4 weeks to 8 weeks resulted in an increase of 37.4 μm in CRT (P < 0.001); however, this was not correlated with a significant change in vision. There was 1 (2%) patient who lost more than 5 ETDRS letters, and 27 (55%) patients who gained more than 5 letters. Two (4%) patients had a more than 150 μm increase in CRT at week 24, and 10 (20%) patients showed a decrease in CRT of more than 150 μm.
  
  
  CONCLUSIONS
  Intravitreal aflibercept is effective in previously treatment-resistant neovascular AMD. Further follow-up is required to determine whether these improvements can be maintained.
authors.affiliation: Sydney Institute of Vision Science, Sydney, Australia; Save Sight Institute, The University of Sydney, Sydney, Australia. Electronic address: achang@sydneyretina.com.au.
authors.forename: Andrew A
authors.initials: AA
authors.lastname: Chang
authors.affiliation: Sydney Institute of Vision Science, Sydney, Australia.
authors.forename: Haitao
authors.initials: H
authors.lastname: Li
authors.affiliation: Sydney Institute of Vision Science, Sydney, Australia; Save Sight Institute, The University of Sydney, Sydney, Australia.
authors.forename: Geoffrey K
authors.initials: GK
authors.lastname: Broadhead
authors.affiliation: Sydney Institute of Vision Science, Sydney, Australia.
authors.forename: Thomas
authors.initials: T
authors.lastname: Hong
authors.affiliation: Sydney School of Public Health, The University of Sydney, Sydney, Australia.
authors.forename: Timothy E
authors.initials: TE
authors.lastname: Schlub
authors.affiliation: Sydney Institute of Vision Science, Sydney, Australia; Save Sight Institute, The University of Sydney, Sydney, Australia.
authors.forename: Wijeyanthy
authors.initials: W
authors.lastname: Wijeyakumar
authors.affiliation: Save Sight Institute, The University of Sydney, Sydney, Australia.
authors.forename: Meidong
authors.initials: M
authors.lastname: Zhu
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D004351:Drug Resistance; D005260:Female; D005451:Fluorescein Angiography; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D058449:Intravitreal Injections; D008297:Male; D011446:Prospective Studies; D040262:Receptors, Vascular Endothelial Growth Factor / Q000009:adverse effects / Q000627:therapeutic use*; D011993:Recombinant Fusion Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology; D057135:Wet Macular Degeneration / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology
chemical_list: D020533:Angiogenesis Inhibitors; D011993:Recombinant Fusion Proteins; C533178:aflibercept; D040262:Receptors, Vascular Endothelial Growth Factor