June 2013
Volume 54, Issue 15
ARVO Annual Meeting Abstract  |   June 2013
Real-life use of ranibizumab in the treatment of diabetic macular edema: results on visual acuity at month 6 in a French Phase IV study (LUDIC study)
Author Affiliations & Notes
  • Pascale Massin
    Ophthalmology, Hopital Lariboisiere, Paris, France
  • Laurent Kodjikian
    Ophthalmology, Hôpital de la Croix Rousse, Lyon, France
  • Marie Laure Lelez
    Ophthalmology, Hôpital Bretonneaux, Tour, France
  • Ali Erginay
    Ophthalmology, Hopital Lariboisiere, Paris, France
  • Stéphane Quéré
    Research Deparment, Novartis Pharma, Reuil Malamison, France
  • Véronique Schneider
    Research Deparment, Novartis Pharma, Reuil Malamison, France
  • Footnotes
    Commercial Relationships Pascale Massin, Novartis (C), Allergan (C), Fovea Pharmaceutical (C), Fournier Abbott (C); Laurent Kodjikian, None; Marie Laure Lelez, None; Ali Erginay, Novartis (R), Bayer (R), Alimera (C); Stéphane Quéré, Novartis Pharma SAS (E); Véronique Schneider, Novartis (E)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2013, Vol.54, 2388. doi:
  • Views
  • Share
  • Tools
    • Alerts
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      Pascale Massin, Laurent Kodjikian, Marie Laure Lelez, Ali Erginay, Stéphane Quéré, Véronique Schneider, ; Real-life use of ranibizumab in the treatment of diabetic macular edema: results on visual acuity at month 6 in a French Phase IV study (LUDIC study). Invest. Ophthalmol. Vis. Sci. 2013;54(15):2388.

      Download citation file:

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

  • Supplements

Purpose: Purpose: To describe the visual acuity (VA) results from a prospective interventional phase IV study designed to investigate efficacy in real-life use of ranibizumab in diabetic macular edema (DME), and compare it with that observed in RESTORE, a key development study

Methods: LUDIC is an open-label single-arm study. Patients recruited at 46 centers were given three monthly injections of ranibizumab and retreated if necessary in strict application of the current Summary of Product Characteristics (SmPC). In contrast with the development studies, no exclusion criteria related to prior treatment for DME were imposed.

Results: Between February and December 2011, 350 patients were enrolled. At baseline mean age was 63.7 years, diabetes had been diagnosed for 18 years and DME had been diagnosed for 2.2 years (mean values). Mean baseline VA was 57.0 ± 10.3 letters, versus 64.7 letters in RESTORE. 48.1% of patients had been treated by laser photocoagulation during the preceding 12 months and 19.7% had been treated with IVT anti-VEGF. The proportion of patients demonstrating a 10 letters gain from baseline after 6 months of IVT ranibizumab treatment (primary endpoint) was 39.9%, versus 34.8% in RESTORE. The mean change in VA from baseline after 6 months was 7.1 ± 10.2 ETDRS letters (6.7± 7.3 in RESTORE at 6 months). The correlation coefficient between gain in VA after 3 consecutive injections and VA at M6 was 0.6678 (p<0.0001). The mean number of injections needed to achieve a VA gain ≥10 letters was 2.3 ± 1.3 injections; the mean number required to achieve stable VA (variation <3 letters) for three consecutive visits was 3.9 ± 1.0.

Conclusions: This phase IV study conducted in a real world setting showed VA gains comparable to those observed in the pivotal study RESTORE despite lower VA at baseline and including patients with broader range of medical histories pretreatments. This confirms the effectiveness of the individualised treatment regimen as recommended in the Lucentis® SmPC and the relevance of the RESTORE study.

Keywords: 499 diabetic retinopathy • 585 macula/fovea • 688 retina  

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.