Extended (Every 12 Weeks or Longer) Dosing Interval With Intravitreal Aflibercept and Ranibizumab in Neovascular Age-Related Macular Degeneration: Post Hoc Analysis of VIEW Trials

Am J Ophthalmol. 2019 Apr:200:161-168. doi: 10.1016/j.ajo.2019.01.005. Epub 2019 Jan 19.

Abstract

Purpose: To evaluate outcomes and disease characteristics in eyes with neovascular age-related macular degeneration that received intravitreal aflibercept injection (IAI) and ranibizumab every 12 weeks or longer (≥q12 weeks) or less than every 12 weeks (<q12 weeks) during year 2 of VIEW studies.

Design: Post hoc analysis of randomized clinical trial data.

Methods: In year 1, eyes received ranibizumab q4 weeks (Rq4), IAI 2 mg q4 weeks (2q4), or IAI 2 mg q8 weeks after 3 monthly injections (2q8). In year 2, eyes received pro re nata treatment, with mandatory treatment at least q12 weeks.

Results: At week 96, 218 (42.5%), 284 (53.9%), and 245 (47.9%) eyes treated with Rq4, 2q4, and 2q8, respectively, received treatment at ≥q12-week intervals and 295 (57.5%), 243 (46.1%), and 266 (52.1%) eyes at <12q-week intervals during the second year. Baseline occult-type choroidal neovascularization (CNV) (P = .0156) and retinal fluid (P < .0001) and leakage (P < .0001) at week 52 were associated with <q12-week dosing. Mean best-corrected visual acuity gains from baseline with Rq4, 2q4, and 2q8 at ≥q12-week interval were 8.7, 9.9, and 9.7 letters at week 52 and 8.5, 8.8, and 9.2 letters at week 96, respectively. The corresponding gains with <q12-week dosing were 10.3, 9.7, and 8.9 letters at week 52 and 9.1, 7.7, and 8.1 letters at week 96.

Conclusions: Baseline CNV type other than occult and absence of retinal fluid and leakage at week 52 were significantly associated with ≥q12-week dosing. Vision improvements at week 52 following a year of fixed dosing with ranibizumab and IAI were maintained at week 96 in eyes that received treatment ≥q12 weeks and <q12 weeks.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angiogenesis Inhibitors / administration & dosage*
  • Choroidal Neovascularization / diagnosis
  • Choroidal Neovascularization / drug therapy*
  • Choroidal Neovascularization / physiopathology
  • Double-Blind Method
  • Female
  • Fluorescein Angiography
  • Humans
  • Intravitreal Injections
  • Male
  • Middle Aged
  • Ranibizumab / administration & dosage*
  • Receptors, Vascular Endothelial Growth Factor / administration & dosage*
  • Recombinant Fusion Proteins / administration & dosage*
  • Time Factors
  • Tomography, Optical Coherence
  • Vascular Endothelial Growth Factor A / antagonists & inhibitors
  • Visual Acuity / physiology
  • Wet Macular Degeneration / diagnosis
  • Wet Macular Degeneration / drug therapy*
  • Wet Macular Degeneration / physiopathology

Substances

  • Angiogenesis Inhibitors
  • Recombinant Fusion Proteins
  • VEGFA protein, human
  • Vascular Endothelial Growth Factor A
  • aflibercept
  • Receptors, Vascular Endothelial Growth Factor
  • Ranibizumab