A randomized trial to compare the safety and efficacy of two ranibizumab dosing regimens in a Turkish cohort of patients with choroidal neovascularization secondary to AMD

Acta Ophthalmol. 2015 Sep;93(6):e458-64. doi: 10.1111/aos.12540. Epub 2014 Aug 27.

Abstract

Purpose: To compare visual outcomes, number of visits and ranibizumab injections in patients treated with a Wait & Extend (W&E) or Treat & Observe (T&O) regimen.

Methods: This 12-month, randomized, multicentre, open-label study enrolled patients aged ≥ 50 years with choroidal neovascularization (CNV) secondary to AMD who had not received anti-VEGF agents. Patients received three monthly injections of ranibizumab before randomization (1:1): (i) T&O patients were examined monthly and retreated if needed, (ii) W&E patients had a follow-up visit 1 month later. If no lesions were active, the interval to the next visit was extended by 2 weeks to a maximum of 8 weeks. Active lesions were re-treated and the follow-up schedule restarted. Primary end-point was change in BCVA at Month 12.

Results: Of the 104 screened patients, 99 were eligible and received ≥ 1 ranibizumab injection; 93 were randomized (T&O: 45, W&E: 48). The median (interquartile range [IQR]) change in BCVA (logMAR) from baseline at Month 12 was similar between groups (T&O: -0.12 [0.38]; W&E: -0.18 [0.32], p = 0.267). Median (IQR) number of visits at study end (including screening, baseline and control visit after 1st injection) was 15.0 (1.0) for T&O, and 12.0 (2.0) for W&E (p < 0.001). Injection numbers were similar between groups (median [IQR]: 6.0 [3.0] and 5.0 [4.0], respectively, p = 0.215). Adverse events were similar between groups.

Conclusion: W&E regimen resulted in a similar efficacy and safety profile to the labelled T&O regimen in patients with CNV secondary to AMD, and may help reduce the burden of follow-up visits.

Keywords: Treat & Observe regimen; Wait & Extend regimen; age-related macular degeneration; ranibizumab.

Publication types

  • Clinical Trial, Phase IV
  • 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*
  • Angiogenesis Inhibitors / adverse effects
  • Choroidal Neovascularization / diagnosis
  • Choroidal Neovascularization / drug therapy*
  • Choroidal Neovascularization / etiology
  • Choroidal Neovascularization / physiopathology
  • Female
  • Fluorescein Angiography
  • Follow-Up Studies
  • Humans
  • Intravitreal Injections
  • Male
  • Middle Aged
  • Observation
  • Ranibizumab / administration & dosage*
  • Ranibizumab / adverse effects
  • Tomography, Optical Coherence
  • Turkey
  • Vascular Endothelial Growth Factor A / antagonists & inhibitors
  • Visual Acuity / physiology
  • Watchful Waiting
  • Wet Macular Degeneration / complications
  • Wet Macular Degeneration / diagnosis
  • Wet Macular Degeneration / drug therapy*
  • Wet Macular Degeneration / physiopathology

Substances

  • Angiogenesis Inhibitors
  • VEGFA protein, human
  • Vascular Endothelial Growth Factor A
  • Ranibizumab