June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Evaluation of time-to-recurrence of disease activity in treatment-naïve patients with neovascular age-related macular degeneration after ranibizumab treatment: 12-month analysis from the ORACLE study
Author Affiliations & Notes
  • Maddalena Quaranta
    Ophthalmology, Centre Rabelais, Lyon, France
  • François DEVIN
    Ophthalmology, Centre Monticelli Paradis, Marseille, France
  • Gabriel QUENTEL
    Ophthalmology, Centre Imagerie et Laser, Paris, France
  • Joël UZZAN
    Ophthalmology, Clinique Mathilde, Rouen, France
  • Eric Fourmaux
    Ophthalmology, Rétine Gallien, Bordeaux, France
  • Laurent CASTELNOVO
    Ophthalmology, Clinique Maison Rouge, Strasbourg, France
  • Wilfried ROQUET
    Ophthalmology, Centre Blatin, Clermont-Ferrand, France
  • Catherine FRANCAIS-MAURY
    Ophthalmology, Centre de l'Odéon , Paris, France
  • Sam RAZAVI
    Ophthalmology, Clinique Saint-Gatien, Tours, France
  • Nathalie San Nicolas
    Ophthalmology, Novartis Pharma SAS, Rueil-Malmaison, France
  • Footnotes
    Commercial Relationships   Maddalena Quaranta, Novartis (C); François DEVIN, Novartis,Bayer, Roche, Ophthotech, Zeiss, Thea and Allergan (C); Gabriel QUENTEL, Novartis, Alimera, Bayer and Zeiss (C); Joël UZZAN, Allergan, Bayer and Novartis (C); Eric Fourmaux, Allergan, Bayer and Novartis (C); Laurent CASTELNOVO, Allergan, Bayer and Novartis (C); Wilfried ROQUET, Allergan, Thea, Novartis, Bayer (C); Catherine FRANCAIS-MAURY, Allergan, Bayer, Ophthotech, Roche, Topcon and Novartis (C); Sam RAZAVI, Bayer and Novartis (C); Nathalie San Nicolas, Novartis Pharma SAS (E)
  • Footnotes
    Support  Novartis Pharma SAS
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 900. doi:
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      Maddalena Quaranta, François DEVIN, Gabriel QUENTEL, Joël UZZAN, Eric Fourmaux, Laurent CASTELNOVO, Wilfried ROQUET, Catherine FRANCAIS-MAURY, Sam RAZAVI, Nathalie San Nicolas; Evaluation of time-to-recurrence of disease activity in treatment-naïve patients with neovascular age-related macular degeneration after ranibizumab treatment: 12-month analysis from the ORACLE study. Invest. Ophthalmol. Vis. Sci. 2017;58(8):900.

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

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Abstract

Purpose : ORACLE is a real-life study to evaluate the time-to-recurrence of disease activity in newly diagnosed treatment-naïve patients with neovascular age-related macular degeneration (nAMD) treated with ranibizumab over a maximum of 24 months. Here we present the
12-month results from the ORACLE study.

Methods : A 24-month, prospective, multicenter, observational study carried out across 69 centers in France. Treatment-naïve patients with nAMD aged ≥55 years and active choroidal neovascularization were included. Patients received ranibizumab 0.5 mg with decision of monitoring and/or injections visit at the investigator’s discretion. The primary objective was to assess the correlation between time-to-1st and time-to-2nd recurrence of disease activity in enrolled patients with at least a 2nd recurrence over 24 months. Time to recurrence is defined as the time between the last ranibizumab injection and next follow-up visit at which recurrent disease activity is diagnosed. Secondary outcomes include assessment of change in best-corrected visual acuity (BCVA), anatomical parameters, and treatment frequency at different time points. Adverse events (AEs) were recorded to assess the safety of ranibizumab.

Results : Overall, 742 patients were enrolled in the study. The results for efficacy assessment are for the reference population (n=690) unless otherwise stated. Baseline demographics and disease characteristics are presented in Table 1. The mean (SD) time-to-1st and time-to-2nd recurrence were 107.1 (65.8; n=366) and 85.4 (42.6; n=159) days, respectively. The mean (SD) change in BCVA at Month 3 and Month 12 was 5.62 (13.6) and 4.10 (16.3) ETDRS letters respectively. At Month 12, the mean change (SD) in central retinal thickness was −83.79 (123.98) mm. At Month 12, 71.7% (n=403) and 70.1% (n=394) patients had absence of intraretinal and subretinal fluid respectively. The mean number of injections was 5.7 and the mean time (SD) between 2 injections was 52.9 (26.6) days. No new safety findings were identified.

Conclusions : When completed at 24 months, this study will provide valuable data that might help to predict the need for retreatment with ranibizumab and to design individualized management of nAMD. Safety of ranibizumab was in line with its established profile.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

 

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