Cataract surgery in ranibizumab-treated patients with neovascular age-related macular degeneration from the phase 3 ANCHOR and MARINA trials

Am J Ophthalmol. 2011 Nov;152(5):793-8. doi: 10.1016/j.ajo.2011.04.025. Epub 2011 Jul 26.

Abstract

Purpose: To investigate whether cataract surgery was beneficial in patients with neovascular age-related macular degeneration (AMD) receiving monthly ranibizumab injections in the ANCHOR (Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in AMD) and MARINA (Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular AMD) phase 3 trials.

Design: Retrospective analysis.

Methods: Patients were identified who underwent cataract surgery during the 2 pivotal trials. For this analysis, the best-corrected visual acuity (VA) just prior to cataract surgery was referred to as the redefined baseline VA. For the period after cataract surgery, endpoints included change in VA, time to first postsurgery injection, and total number of injections. Monthly follow-up visits after surgery were defined at 30-day intervals ± 15 days.

Results: Three subgroups were identified: study eyes of ranibizumab-treated patients (758 eyes [23 undergoing surgery]), fellow eyes of ranibizumab-treated patients (758 eyes [28 undergoing surgery]), and eyes of non-ranibizumab patients (762 [16 undergoing surgery]). Three months postsurgery, the VA of ranibizumab-treated eyes improved by a mean of 10.4 (± 3.4) letters compared to the redefined baseline (n = 20; 95% confidence interval +3.3 letters to +17.5 letters). The mean VA change from redefined baseline VA was not significantly different between the 3 groups at any of the evaluated time points postsurgery (P > .44 for all comparisons between each pair of the 3 groups at 1, 2, 3, and 4 months following surgery).

Conclusions: In the phase 3 trials, cataract surgery appeared to be safe and beneficial for all eyes with AMD, including ranibizumab-treated eyes with neovascular AMD. An average VA improvement of more than 2 lines was typically observed.

Trial registration: ClinicalTrials.gov NCT00056836 NCT00061594.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Antibodies, Monoclonal, Humanized / administration & dosage*
  • Follow-Up Studies
  • Humans
  • Intravitreal Injections
  • Lens Implantation, Intraocular*
  • Phacoemulsification*
  • Photochemotherapy
  • Porphyrins / therapeutic use
  • Ranibizumab
  • Retrospective Studies
  • Treatment Outcome
  • Verteporfin
  • Visual Acuity / physiology
  • Wet Macular Degeneration / drug therapy*
  • Wet Macular Degeneration / physiopathology

Substances

  • Antibodies, Monoclonal, Humanized
  • Porphyrins
  • Verteporfin
  • Ranibizumab

Associated data

  • ClinicalTrials.gov/NCT00056836
  • ClinicalTrials.gov/NCT00061594