September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Real Life Use of Aflibercept In FraNce: oBservatiOnal study in Wet AMD: the RAINBOW study
Author Affiliations & Notes
  • OUBRAHAM-MEBROUKINE Hassiba
    Cabinet Libéral Montargis, Montargis, France
  • Celine Faure
    Clinique Saint-Martin, Caen, France
  • Florence Coscas
    Cabinet Odeon, Paris, France
  • Thi Ha Chau Tran
    Hopital Saint-Vincent de Paul, Lille, France
  • Benedicte Briend-Joulain
    Pole de Consultation Tassigny, Angers, France
  • Laurent Velasque
    Clinique Tourny, Bordeaux, France
  • Isabelle Aubry
    Centre des Arceaux, Montpellier, France
  • Michel Weber
    CHU Hotel-Dieu, Nantes, France
  • Salomon Y Cohen
    CIL, Paris, France
  • Footnotes
    Commercial Relationships   OUBRAHAM-MEBROUKINE Hassiba, Allergan (C), Bayer (C), Novartis (C); Celine Faure, Alcon (C), Bayer (C), Novartis (C); Florence Coscas, Allergan (C), Bayer (C), Novartis (C), Roche (C); Thi Ha Chau Tran, Bausch&Lomb (C), Bayer (C), Novartis (C); Benedicte Briend-Joulain, None; Laurent Velasque, None; Isabelle Aubry, Bayer (C); Michel Weber, Alcon (C), Alimera (C), Allergan (C), Bayer (C), Novartis (C), Thea (C); Salomon Cohen, Alcon (C), Allergan (C), Bayer (C), Novartis (C), Thea (C)
  • Footnotes
    Support  Bayer/Regeneron
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 524. doi:
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      OUBRAHAM-MEBROUKINE Hassiba, Celine Faure, Florence Coscas, Thi Ha Chau Tran, Benedicte Briend-Joulain, Laurent Velasque, Isabelle Aubry, Michel Weber, Salomon Y Cohen; Real Life Use of Aflibercept In FraNce: oBservatiOnal study in Wet AMD: the RAINBOW study. Invest. Ophthalmol. Vis. Sci. 2016;57(12):524.

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

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Abstract

Purpose : To report interim outcomes of patients having completed one year in the RAINBOW study, aiming to collect efficacy and safety data from real-life clinical practice on naïve wet Age-related Macular Degeneration (wAMD) patients treated with intravitreal aflibercept in France.

Methods : RAINBOW is an observational retrospective and prospective study initiated in January 2014 in France, aiming to enroll 600 patients over 4 years. The primary endpoint is the change in Best Corrected Visual Acuity (BCVA), measured using the ETDRS chart from baseline to 12 months. The worst eye of each patient was considered as study eye, but the second eye could also be considered for the study if treatment-naïve. A preliminary analysis was performed on 92 eyes from 84 patients having completed 1 year of follow-up (Full Analysis Set, comprising all patients/eyes having received at least one injection).

Results : The baseline BCVA is summarized in table 1. The primary endpoint results are summarized in table 2. The mean (± SD) number of injections at 12 months was 7.2 (±2.6) in the eyes. Two patients (2.4%) experienced one serious adverse event each, one of which (stroke) was treatment-related, while the other (pneumonia) was not.

Conclusions : The interim analysis of the RAINBOW study showed significant BCVA gains at 12 months (5.9 letters with an average of 7.2 injections) in wAMD naïve patients treated under real-life conditions. No new safety signals were detected.

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

 

 

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