Changes in intraocular pressure in study and fellow eyes in the IVAN trial

Br J Ophthalmol. 2016 Dec;100(12):1662-1667. doi: 10.1136/bjophthalmol-2015-307595. Epub 2016 Apr 12.

Abstract

Purpose: To describe changes in intraocular pressure (IOP) in the 'alternative treatments to Inhibit VEGF in Age-related choroidal Neovascularisation (IVAN)' trial (registered as ISRCTN92166560).

Design: Randomised controlled clinical trial with factorial design.

Participants: Patients (n=610) with treatment naïve neovascular age-related macular degeneration were enrolled and randomly assigned to receive either ranibizumab or bevacizumab and to two regimens, namely monthly (continuous) or as needed (discontinuous) treatment.

Methods: At monthly visits, IOP was measured preinjection in both eyes, and postinjection in the study eye.

Outcome measures: The effects of 10 prespecified covariates on preinjection IOP, change in IOP (postinjection minus preinjection) and the difference in preinjection IOP between the two eyes were examined.

Results: For every month in trial, there was a statistically significant rise in both the preinjection IOP and the change in IOP postinjection during the time in the trial (estimate 0.02 mm Hg, 95% CI 0.01 to 0.03, p<0.001 and 0.03 mm Hg, 95% CI 0.01 to 0.04, p=0.002, respectively). There was also a small but significant increase during the time in trial in the difference in IOP between the two eyes (estimate 0.01 mm Hg, 95% CI 0.005 to 0.02, p<0.001). There were no differences between bevacizumab and ranibizumab for any of the three outcomes (p=0.93, p=0.22 and p=0.87, respectively).

Conclusions: Anti-vascular endothelial growth factor agents induce increases in IOP of small and uncertain clinical significance.

Trial registration number: ISRCTN92166560.

Keywords: Glaucoma; Macula; Pharmacology.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angiogenesis Inhibitors
  • Bevacizumab / administration & dosage*
  • Female
  • Follow-Up Studies
  • Humans
  • Intraocular Pressure / drug effects
  • Intraocular Pressure / physiology*
  • Intravitreal Injections
  • Macular Degeneration / drug therapy
  • Macular Degeneration / etiology
  • Macular Degeneration / physiopathology*
  • Middle Aged
  • Ranibizumab / administration & dosage*
  • Retinal Neovascularization / complications
  • Retinal Neovascularization / drug therapy
  • Retinal Neovascularization / physiopathology*
  • Time Factors
  • Tonometry, Ocular
  • Treatment Outcome
  • Visual Acuity*

Substances

  • Angiogenesis Inhibitors
  • Bevacizumab
  • Ranibizumab