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Clinical science
Safety and tolerability of ranibizumab in uni/bilateral neovascular age-related macular degeneration: 12-month TWEYEs study
  1. Francesco Bandello1,
  2. Giovanni Staurenghi2,
  3. Federico Ricci3,
  4. Edoardo Midena4,
  5. Francesco Viola5,
  6. Tommaso Lupieri Sinibaldi6,
  7. Laura Colombo6,
  8. Elena Peruzzi6,
  9. Stefania Bassanini6
  1. 1 Department of Ophthalmology, University Vita Salute Hospital San Raffaele, Milano, Italy
  2. 2 Department of Biomedical and Clinical Science Luigi Sacco, Luigi Sacco Hospital, University of Milan, Milan, Italy
  3. 3 UOSD Patologie Retiniche, Policlinico Tor Vergata, University Tor Vergata, Rome, Italy
  4. 4 Department of Ophthalmology, University of Padua, Padova, Italy
  5. 5 Department of Clinical Sciences and CommunityHealth, University of Milan, Ophthalmological Unit, IRCCS-Cà GrandaFoundation—Ospedale Maggiore Policlinico, Milano, Italy
  6. 6 Novartis Farma S.p.A, Largo Umberto Boccioni, Origgio, Origgio, Italy
  1. Correspondence to Dr Francesco Bandello, Department of Ophthalmology, University Vita Salute Hospital San Raffaele, Milano, Italy; bandello.francesco{at}hsr.it

Abstract

Background To evaluate the safety and tolerability of ranibizumab 0.5 mg in patients with uni/bilateral neovascular age-related macular degeneration (nAMD) and best-corrected visual acuity (BCVA)<2/10 and/or second eye affected, regardless of BCVA.

Methods In this 12-month, prospective, multicentre, open-label, single arm, pragmatic interventional study, patients (N=941) aged ≥ 50 years were to receive ranibizumab as per approved label, monthly until maximum stable visual acuity (VA) was achieved (initially, three or more injections may be required). Thereafter, patients were to be monitored monthly for VA and treatment was to be resumed if VA was reduced due to disease activity.

Results Of the 936 patients treated with ranibizumab at least once during the study, 823/113 were unilaterally/bilaterally (not simultaneously) treated . The mean (SD) number of ranibizumab injections during the study was 5.4 (2.9)/10.6 (5.0) injections in uni/bilaterally treated patients. Three systemic drug-related adverse events (AEs) (all serious, all in unilaterally treated patients) and 18 systemic AE of special interest (AESIs) (11 serious, 16/2 in unilaterally/bilaterally treated patients) occurred during the study. The annual incidence rate (AIR) (events/1000 person-years) for systemic drug-related AEs, considering a 15-day/30-day risk period, 11.0/8.5 for unilaterally treated patients. Considering the same risk period, the AIR (events/1000 person-years) for systemic AESIs for unilaterally treated patients was 22.1/19.9. Considering a 30-day risk period, the AIR (events/1000 treated eye-years) of ocular drug-related AEs was 23 and AESIs was 11.5.

Conclusions The low incidence of AEs and AESIs demonstrated the good safety and tolerability of ranibizumab in unilaterally/bilaterally treated patients with nAMD in this real-world setting.

  • neovascularisation
  • retina
  • vision
  • age-related macular degeneration
  • unilateral AMD
  • bilateral AMD
  • neovascular age-related macular degeneration

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bjophthalmol-2019-313907

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    Footnotes

    • Correction notice This paper has been amended since it was published Online First. The TWEYEs study authors have added an acknowledgement to the principal investigators across all the sites who contributed to this study.

    • Contributors Conception and design: FB, GS, EP. Analysis and interpretation: FB, GS, FR, EM, FV, TLS, LC, EP, SB. Data collection: TLS, LC, EP, SB. Overall responsibility: FB, GS, FR, EM, FV, TLS, LC, EP, SB.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests FB: Consultant—Acucela (Seattle, Washington), Alcon (Fort Worth, Texas), Bayer (Leverkusen, Germany), Boehringer-Ingelheim (Ingelheim, Germany), Genentech (South San Francisco, California), Heidelberg Engineering (Heidelberg, Germany), Novartis (Basel, Switzerland), Roche (Basel, Switzerland) and Zeiss (Oberkochen, Germany); Financial support—Bayer (Leverkusen, Germany), Genentech (South San Francisco, California), Heidelberg Engineering (Heidelberg, Germany), Novartis (Basel, Switzerland), Roche (Basel, Switzerland) and Zeiss (Oberkochen, Germany). GS: Consultant—Novartis (Basel, Switzerland), Bayer HealthCare (Leverkusen, Germany), Allergan (Dublin, Ireland), Genentech (South San Francisco, California), Roche (Basel, Switzerland), Heidelberg Engineering (Heidelberg, Germany) and Alcon (Fort Worth, Texas); Financial support—Bayer HealthCare (Leverkusen, Germany), Centervue (Padova, Italy), Heidelberg Engineering (Heidelberg, Germany) and Novartis (Basel, Switzerland); Lecturer—Zeiss (Oberkochen, Germany); Patent holder—in conjunction with Ocular Instruments, Inc. (Bellevue, Washington); Payment for development of educational presentations—Roche (Basel, Switzerland). FR: Alcon (Fort Worth, Texas), Bayer (Leverkusen, Germany), Novartis (Basel, Switzerland), Roche (Basel, Switzerland), Allergan (Dublin, Ireland), SIFI (Catania, Italy). FV: Consultant—Novartis (Basel, Switzerland), Bayer HealthCare (Leverkusen, Germany), Financial support—Allergan (Dublin, Ireland), Novartis (Basel, Switzerland), Bayer HealthCare (Leverkusen, Germany), SIFI (Catania, Italy). TLS: Employee—Novartis Farma S.p.A (Origgio, Italy) at the time of development of the manuscript and submission. EP, SB: Employees—Novartis Farma S.p.A (Origgio, Italy). LC: Employee—Novartis Farma S.p.A (Origgio, Italy) at the time of development of the manuscript and submission.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available on request.

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