title: Intraocular Pressure in Patients with Neovascular Age-Related Macular Degeneration Receiving Intravitreal Aflibercept or Ranibizumab.
abstract: OBJECTIVE
  To assess change in intraocular pressure (IOP) in patients with neovascular age-related macular degeneration (NVAMD) receiving intravitreal aflibercept injection (IAI) or ranibizumab in VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) 1 and 2 studies.
  
  
  METHODS
  Analyses from 2 randomized, active-controlled, phase III trials.
  
  
  METHODS
  A total of 2457 patients with NVAMD.
  
  
  METHODS
  Patients received IAI 2 mg every (q) 4 weeks (2q4), 0.5 mg q4 weeks (0.5q4), 2 mg q8 weeks (after 3 monthly doses; 2q8), or ranibizumab 0.5 mg q4 weeks (Rq4) for 52 weeks. At week 52, patients were switched to a variable regimen requiring at least quarterly dosing and allowing interim injections based on anatomic and visual assessment.
  
  
  METHODS
  Pre-injection IOP was analyzed in study and uninjected fellow eyes from baseline to week 96. Prespecified end points included mean change in IOP from baseline and prevalence of a >21 mmHg and >10 mmHg increase in IOP from baseline. Cumulative incidence of sustained (at 2 consecutive visits) IOP >21 mmHg, a single event of IOP >25 mmHg, and sustained IOP increase from baseline (≥5 mmHg) was also evaluated.
  
  
  RESULTS
  Mean IOP change from baseline over 96 weeks in all IAI groups was consistently lower than in the Rq4 group, and this finding was replicated in both trials. In an analysis integrating both studies, the proportion of study eyes with IOP >21 mmHg at week 96 was 20.2%, 14.2%, 12.1%, and 12.5% in Rq4, 2q4, 2q8, and 0.5q4, respectively. Reduction in risk, relative to Rq4, of having sustained IOP >21 mmHg over 96 weeks was 62% (95% confidence interval [CI], 36%-78%), 50% (95% CI, 19%-70%), and 69% (95% CI, 45%-84%) for 2q4, 2q8, and 0.5q4, respectively. Risk reduction in the IAI groups for a sustained IOP increase ≥5 mmHg was 31% (95% CI, 8%-48%), 38% (95% CI, 17%-54%), and 47% (95% CI, 27%-61%), respectively. In uninjected fellow eyes, only sustained IOP >21 mmHg events were higher in the Rq4 group compared with all IAI groups.
  
  
  CONCLUSIONS
  Incidence of elevated IOP in eyes with NVAMD was lower in all IAI groups than in the ranibizumab group.
authors.affiliation: Vitreous Retina Macula Consultants of New York, New York, New York; LuEsther T. Mertz Retinal Research Center, Manhattan Eye, Ear, and Throat Institute, New York, New York; Edward S. Harkness Eye Institute, Columbia University College of Physicians and Surgeons, New York, New York; Department of Ophthalmology, New York University Medical Center, New York, New York. Electronic address: kbfnyf@aol.com.
authors.forename: K Bailey
authors.initials: KB
authors.lastname: Freund
authors.affiliation: Vitreous Retina Macula Consultants of New York, New York, New York; LuEsther T. Mertz Retinal Research Center, Manhattan Eye, Ear, and Throat Institute, New York, New York; Edward S. Harkness Eye Institute, Columbia University College of Physicians and Surgeons, New York, New York; Department of Ophthalmology, New York University Medical Center, New York, New York.
authors.forename: Quan V
authors.initials: QV
authors.lastname: Hoang
authors.affiliation: Regeneron Pharmaceuticals, Inc., Tarrytown, New York.
authors.forename: Namrata
authors.initials: N
authors.lastname: Saroj
authors.affiliation: Regeneron Pharmaceuticals, Inc., Tarrytown, New York.
authors.forename: Desmond
authors.initials: D
authors.lastname: Thompson
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects* / Q000502:physiology; D058449:Intravitreal Injections; D008297:Male; D009798:Ocular Hypertension / Q000139:chemically induced* / Q000503:physiopathology; D000069579:Ranibizumab; D040262:Receptors, Vascular Endothelial Growth Factor / Q000009:adverse effects* / Q000627:therapeutic use; D011993:Recombinant Fusion Proteins / Q000009:adverse effects* / Q000627:therapeutic use; D014065:Tonometry, Ocular; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D057135:Wet Macular Degeneration / Q000188:drug therapy* / Q000503:physiopathology
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D011993:Recombinant Fusion Proteins; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; C533178:aflibercept; D040262:Receptors, Vascular Endothelial Growth Factor; D000069579:Ranibizumab