September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Time to recurrence in neovascular age-related macular degeneration after ranibizumab treatment: baseline characteristics of treatment-naive patients enrolled in the ORACLE study
Author Affiliations & Notes
  • François Devin
    Ophtalmology, Centre Monticelli Paradis, Marseille, France
  • Eric Fourmaux
    Ophtalmology, Palais Galien, Bordeaux, France
  • gabriel quentel
    Centre Imagerie et Laser, Paris, France
  • Joel Uzzan
    Ophtalmology, Clinique Mathilde, Rouen, France
  • Maddalena QUARANTA EL-MAFTOUHI
    Ophtalmology, Centre Rabelais, Lyon, France
  • Catherine Français-Maury
    Ophtalmology, Centre de l'Odéon, Paris, France
  • Wilfried Roquet
    Ophtalmology, Centre Blatin, Clermont-Ferrand, France
  • Laurent Castelnovo
    Ophtalmology, Clinique Maison Rouge, Strasbourg, France
  • Sam Razavi
    Ophtalmology, Clinique Saint-Gatien, Tours, France
  • Laetitia Finzi
    Retine, Novartis Pharma SAS, Rueil-Malmaison, France
  • Footnotes
    Commercial Relationships   François Devin, Allergan (C), Bayer (C), Novartis (C), Ophthotec (C), Roche (C), Thea (C), Zeiss (C); Eric Fourmaux, Novartis (C); gabriel quentel, Alimera (C), Bayer (C), Novartis (C), Zeiss (C); Joel Uzzan, Novartis (C); Maddalena QUARANTA EL-MAFTOUHI, Novartis (C); Catherine Français-Maury, Novartis (C); Wilfried Roquet, Novartis (C); Laurent Castelnovo, Novartis (C); Sam Razavi, Bayer (C), Novartis (C); Laetitia Finzi, Novartis (E)
  • Footnotes
    Support  Novartis Pharma SAS
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 3353. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to Subscribers Only
      Sign In or Create an Account ×
    • Get Citation

      François Devin, Eric Fourmaux, gabriel quentel, Joel Uzzan, Maddalena QUARANTA EL-MAFTOUHI, Catherine Français-Maury, Wilfried Roquet, Laurent Castelnovo, Sam Razavi, Laetitia Finzi; Time to recurrence in neovascular age-related macular degeneration after ranibizumab treatment: baseline characteristics of treatment-naive patients enrolled in the ORACLE study. Invest. Ophthalmol. Vis. Sci. 2016;57(12):3353.

      Download citation file:


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

      ×
  • Supplements
Abstract

Purpose : Attempts have been made to individualize ranibizumab treatment using pro re nata and treat-and-extend regimens to fit therapeutic procedures to the rhythm of recurrences of choroidal neovascularization (CNV). The ability to predict the recurrence interval for an individual patient would help in making retreatment decisions in wet age-related macular degeneration (wAMD). ORACLE is an ongoing 24-month, multicenter, observational study, designed to evaluate the time to recurrence of disease activity in newly diagnosed wAMD patients treated with ranibizumab over 2 years. Here we present baseline characteristics of the enrolled population.

Methods : Patients were enrolled at 69 centers across France between March 2014 and July 2015. Consenting adult patients aged ≥ 55 years with treatment-naïve and active subfoveal CNV were included. The decision to retreat was at the investigator’s discretion. The key endpoints of the study are summarized in Table 1.

Results : Of the 746 patients screened, 706 were enrolled into the study. The mean age (± SD) of patients was 80.2 (± 7.4) years, 66.9% were females and 26.1% had bilateral disease. The mean (± SD) time between diagnosis and initiation of the treatment was 3.16 (± 47.3) days. In the majority of patients, the CNV subtype was categorized as occult (52.6%) followed by predominantly classic (32.9%) and classic (14.5%). For the study eye, the mean best corrected visual acuity at baseline was 58.0 (± 16.9) letters and the mean central retinal thickness was 362.1 (± 115) µm. Other baseline ocular characteristics are presented in Table 2. On optical coherence tomographic (OCT) scans, 48.2% (n = 340) patients had Pigment Epithelial Detachments (PED) at baseline with a mean PED height of 218.7 µm (n = 225).

Conclusions : The overall baseline characteristics of the study cohort give insight on the demographics, functional and anatomical parameters of treatment-naïve patients with wAMD. These epidemiological data from the ORACLE study will help to better define the profile of wAMD patients initiating ranibizumab in 2015. This study will further provide data to better predict the need for retreatment with ranibizumab in wAMD.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

 

Table 1: Key endpoints of the ORACLE study

Table 1: Key endpoints of the ORACLE study

 

Table 2: Other baseline ocular characteristics of wAMD patients in the ORACLE study

Table 2: Other baseline ocular characteristics of wAMD patients in the ORACLE study

×
×

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.

×