June 2015
Volume 56, Issue 7
ARVO Annual Meeting Abstract  |   June 2015
Similar two-year safety profiles of bilateral versus unilateral treatments with ranibizumab 0.5 mg in nAMD and DME
Author Affiliations & Notes
  • Sergio Pagliarini
    Ophthalmology, Univ Hospitals Coventry & Warwickshire, Hospital of St Cross, Rugby, United Kingdom
  • Katja B Hatz
    Department of Ophthalmology, Vista Klinik, Binningen, Switzerland
  • Philippe Margaron
    Novartis Pharma AG, Basel, Switzerland
  • Vladimir Bezlyak
    Novartis Pharma AG, Basel, Switzerland
  • Christine Thorburn
    Novartis Pharmaceuticals UK Ltd., Frimley, Surrey, United Kingdom
  • Footnotes
    Commercial Relationships Sergio Pagliarini, Alcon (R), Allergan (R), Bayer (C), Novartis (C), Novartis (F), Novartis (R); Katja Hatz, Allergan (C), Bayer (C), Bayer (R), Novartis (C); Philippe Margaron, Novartis (E); Vladimir Bezlyak, Novartis (E); Christine Thorburn, Novartis (E)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2015, Vol.56, 1510. doi:
  • Views
  • Share
  • Tools
    • Alerts
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      Sergio Pagliarini, Katja B Hatz, Philippe Margaron, Vladimir Bezlyak, Christine Thorburn; Similar two-year safety profiles of bilateral versus unilateral treatments with ranibizumab 0.5 mg in nAMD and DME. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1510.

      Download citation file:

      © ARVO (1962-2015); The Authors (2016-present)

  • Supplements

Purpose: Patients with neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) often present with bilateral disease requiring treatment in both eyes. There are limited data available which compare the safety profile of unilateral treatment (UT) with anti-VEGF agents to that of bilateral treatment (BT). Therefore, we analyzed the differential 2-yr safety profiles of BT and UT patients in the observational EPICOHORT (nAMD) and the interventional RETAIN (DME; http://clinicaltrials.gov, NCT01171976, registered: 07-27-2010, trial start: 09-2010) studies that allowed for long-term bilateral ranibizumab 0.5 mg (RBZ) treatment (pro-re-nata or treat-and-extend).

Methods: Retrospective analysis of the 2-yr treatment exposure and safety profiles of RBZ in EPICOHORT (n=755) and RETAIN (n=370) patients (bilateral treatment administered at the investigator’s discretion). Treatment exposure was assessed by the mean injection number and interval between injections. The safety profiles included the proportions of patients with ocular and systemic adverse events (AE incidences) and AE types.

Results: Overall, 18% (n=133) patients from EPICOHORT and 45% (n=166) patients from RETAIN received BT. The 2-yr RBZ exposure was higher in BT compared to UT patients; mean intervals between injections and numbers of injections (BT/UT): 20/41 days and 12.4/6.0 (nAMD), 11/26 days and 18.9/10.9 (DME), respectively. In contrast, the BT/UT safety profiles were similar for systemic AEs with overall AE incidences of 31.6/31.2% (nAMD) and 77.7/73.5% (DME). The 2-yr incidences of cerebrovascular thromboembolic events (BT/UT: 0.8/1.1% nAMD, 3.0/2.5% DME) and myocardial infarction (acute and non-acute; BT/UT: 0/0.6% nAMD, 1.8/2.5% DME) were comparable. Also, the overall BT/UT ocular AE incidences were similar in nAMD (39.1/34.1%) but higher in DME (65.1/47.5%) due to AEs associated with the injection procedure and complications related to diabetes (conjunctival hemorrhage, cataract, and worsening of retinal edema).

Conclusions: The analysis revealed similar systemic AE profiles of RBZ in BT and UT patients with nAMD and DME, indicating no clinical impact of bilateral treatment on systemic safety. Furthermore this analysis showed no unexpected increase in ocular AE incidences with BT compared with UT in patients with nAMD and DME.


This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.