title: SHORT-TERM SAFETY PROFILE OF INTRAVITREAL ZIV-AFLIBERCEPT.
abstract: OBJECTIVE
  To evaluate the safety of intravitreal ziv-aflibercept (Zaltrap) in the treatment choroidal neovascularization secondary to age-related macular degeneration.
  
  
  METHODS
  Eligible eyes with choroidal neovascularization secondary to age-related macular degeneration each received a single intravitreal injection of ziv-aflibercept. Comprehensive ophthalmic examinations and detailed systemic evaluations were performed at baseline and Days 1, 7, and 30 after injection, and International Society for Clinical Electrophysiology of Vision standard electroretinography was performed at baseline and Day 30. Primary outcome measures were safety parameters that included signs of clinical and electroretinographic toxicity. Secondary outcome measures included changes in best-corrected visual acuity and central subfield thickness.
  
  
  RESULTS
  Twelve eyes of 12 patients were treated. None of the patients complained of blurred vision, ocular pain, or bulbar injection at any of the follow-up visits, nor was intraocular inflammation noted. There were no significant differences in implicit times, "a" and "b" wave amplitudes, or b/a ratios at 1 month when compared with baseline (P = 0.4). None of the patients experienced serious ocular or systemic adverse events. Mean best-corrected visual acuity improved only slightly at 30 days (LogMAR 0.45 ± 0.31 [Snellen equivalent: 20/60]) compared with baseline (LogMAR 0.37 ± 0.24 [Snellen equivalent: 20/50]; P = 0.51).
  
  
  CONCLUSIONS
  Single intravitreal injections of ziv-aflibercept into eyes with neovascular age-related macular degeneration appear to be safe through 1 month. Ziv-aflibercept could become a safe, low-cost therapy for macular diseases in developing countries and in those where intravitreal aflibercept (Eylea) is not available.
authors.affiliation: *Srimati Kanuri Santhamma Centre for Vitreo-Retinal Diseases, Hyderabad Eye Research Foundation, Kallam Anji Reddy Campus, L V Prasad Eye Institute, Hyderabad, India; and †Department of Ophthalmology, Mayo Clinic, Florida.
authors.forename: Jay
authors.initials: J
authors.lastname: Chhablani
authors.forename: Raja
authors.initials: R
authors.lastname: Narayanan
authors.forename: Annie
authors.initials: A
authors.lastname: Mathai
authors.forename: Rohit
authors.initials: R
authors.lastname: Yogi
authors.forename: Michael
authors.initials: M
authors.lastname: Stewart
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000009:adverse effects*; D020256:Choroidal Neovascularization / Q000175:diagnosis / Q000188:drug therapy*; D004596:Electroretinography / Q000187:drug effects*; D005260:Female; D005451:Fluorescein Angiography; D006801:Humans; D058449:Intravitreal Injections; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D040262:Receptors, Vascular Endothelial Growth Factor; D011993:Recombinant Fusion Proteins / Q000009:adverse effects*; D012160:Retina / Q000187:drug effects; D041623:Tomography, Optical Coherence; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity / Q000187:drug effects*; D057135:Wet Macular Degeneration / Q000175:diagnosis / Q000188:drug therapy*
chemical_list: D020533:Angiogenesis Inhibitors; D011993:Recombinant Fusion Proteins; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; C533178:aflibercept; D040262:Receptors, Vascular Endothelial Growth Factor