June 2020
Volume 61, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2020
Treatment switch from aflibercept to ranibizumab pre-filled syringe in Canadian nAMD and DME patients in a real-world setting: The PRECISE study
Author Affiliations & Notes
  • Sohel Somani
    Department of Ophthalmology & Vision Sciences, University of Toronto, Canada, Toronto, Ontario, Canada
  • Michel Giunta
    Department of Ophthalmology, University of Sherbrooke, Sherbrooke, Quebec, Canada
  • Ananda Kalevar
    Department of Ophthalmology, University of Sherbrooke, Sherbrooke, Quebec, Canada
  • Raman Tuli
    Department of Ophthalmology, University of Ottawa, Ottawa, Ontario, Canada
    The Retina Centre of Ottawa, Ottawa, Ontario, Canada
  • Louis Caron
    Department of Ophthalmology, Université Laval, Quebec City, Quebec, Canada
  • Pierre Trottier
    LASIK MD, Quebec, Canada
  • Shamiza Hussein
    Novartis Pharma Canada Inc., Dorval, Quebec, Canada
  • Eser Adiguzel
    Novartis Pharma Canada Inc., Dorval, Quebec, Canada
  • Footnotes
    Commercial Relationships   Sohel Somani, Bayer (R), Novartis (S); Michel Giunta, Abbott (S), Alcon (S), Allergan (F), Bausch & Lomb (S), Bayer AG (F), Bayer AG (S), Chengdu Kanghong Biotechnology (F), F. Hoffmann-La Roche (F), Novartis (S), Novartis (F); Ananda Kalevar, Alcon (S), Allergan (S), Bayer (S), Novartis (S); Raman Tuli, Apelis (F), Bayer (S), Novartis (S), Novartis (F), Roche (F); Louis Caron, Novartis (F); Pierre Trottier, Alcon (C), Allergan (C), Bausch&Lomb (C), Bayer (C), Novartis (C), Thea Laboratories (C); Shamiza Hussein, Novartis Pharma Canada Inc. (E); Eser Adiguzel, Novartis Pharma Canada Inc. (E)
  • Footnotes
    Support  Sponsored by Novartis Pharmaceuticals Canada
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 4203. doi:
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      Sohel Somani, Michel Giunta, Ananda Kalevar, Raman Tuli, Louis Caron, Pierre Trottier, Shamiza Hussein, Eser Adiguzel; Treatment switch from aflibercept to ranibizumab pre-filled syringe in Canadian nAMD and DME patients in a real-world setting: The PRECISE study. Invest. Ophthalmol. Vis. Sci. 2020;61(7):4203.

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

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Abstract

Purpose : PRECISE is the first study to evaluate treatment outcomes in nAMD and DME patients with an inadequate response to aflibercept (AFL) who were switched to ranibizumab pre-filled syringe (RBZ-PFS) in a routine clinical setting. There are limited data from real-world on treatment switch in patients showing inadequate response to ongoing AFL and thus far, there is no report on treatment switch exclusively to RBZ-PFS.

Methods : PRECISE is an ongoing, prospective, observational, multicenter, real-world switch study in prior AFL-treated Canadian nAMD and DME patients. Eligible patients, ≥18 years, who received ≥3 AFL injections, were switched to RBZ-PFS based on clinician’s discretion and treated as per the product label. Primary endpoint is the mean change from baseline to day 90 in central retinal thickness. Secondary endpoints include best-corrected visual acuity change, treatment regimen and safety. The study aims to enroll ~396 eyes (nAMD/DME=320/76) from 15 clinical centers across Canada.

Results : Results are presented for currently enrolled 76/18 nAMD/DME patients, respectively. At baseline, nAMD patients presented with occult (18.4%), classic (25%) and mixed (23.7%) CNV, 1.3% PCV and 31.6% were unknown/undiagnosed/other. Amongst DME patients, 11.1% and 88.9% had Type 1 and Type 2 diabetes, respectively, with 94.4% controlled with medication. Mean time since diagnosis to treatment switch to RBZ-PFS was 3.8 years in both groups. Prior to study entry, nAMD/DME patients received a mean (SD) of 26.1(18.2)/ 15.6(11.2) of any anti-VEGF injections and 18.9(13.1)/13.1(10.7) of AFL injections. Key reasons for treatment switch in the nAMD/DME patients were (i) lack treatment response (persistent fluid: 51.3%/72.2%; loss of vision: 7.9%/5.6%; unsatisfactory vision gains: 6.6%/0.0%); (ii) unable to extend dosing (17.1%/5.6%); (iii) safety (ocular: 11.8%/5.6%). Other baseline characteristics of switch patients and preliminary treatment outcomes will be presented.

Conclusions : Real-world evidence from the PRECISE study provides useful information that the key reason for treatment switch was lack of response to AFL treatment, primarily due to presence of fluid in the macula. Results from our study will further our current understanding and enhance routine clinical care of these patients.

This is a 2020 ARVO Annual Meeting abstract.

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