Safety and tolerability of ranibizumab in uni/bilateral neovascular age-related macular degeneration: 12-month TWEYEs study

Francesco Bandello, Giovanni Staurenghi, Federico Ricci, Edoardo Midena, Francesco Viola, Tommaso Lupieri Sinibaldi, Laura Colombo, Elena Peruzzi, Stefania Bassanini

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)64-73
JournalBritish Journal of Ophthalmology
Volume104
Issue number1
DOIs
Publication statusPublished - 2020

Fingerprint

Macular Degeneration
Safety
Visual Acuity
Drug-Related Side Effects and Adverse Reactions
Incidence
Anniversaries and Special Events
Injections
Ranibizumab
Arm

Keywords

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

ASJC Scopus subject areas

  • Ophthalmology
  • Sensory Systems
  • Cellular and Molecular Neuroscience

Cite this

Safety and tolerability of ranibizumab in uni/bilateral neovascular age-related macular degeneration : 12-month TWEYEs study. / Bandello, Francesco; Staurenghi, Giovanni; Ricci, Federico; Midena, Edoardo; Viola, Francesco; Lupieri Sinibaldi, Tommaso; Colombo, Laura; Peruzzi, Elena; Bassanini, Stefania.

In: British Journal of Ophthalmology, Vol. 104, No. 1, 2020, p. 64-73.

Research output: Contribution to journalArticle

@article{3b3923c95987452eb65e26e8a9ab1769,
title = "Safety and tolerability of ranibizumab in uni/bilateral neovascular age-related macular degeneration: 12-month TWEYEs study",
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.",
keywords = "age-related macular degeneration, bilateral AMD, neovascular age-related macular degeneration, neovascularisation, retina, unilateral AMD, vision",
author = "Francesco Bandello and Giovanni Staurenghi and Federico Ricci and Edoardo Midena and Francesco Viola and {Lupieri Sinibaldi}, Tommaso and Laura Colombo and Elena Peruzzi and Stefania Bassanini",
year = "2020",
doi = "10.1136/bjophthalmol-2019-313907",
language = "English",
volume = "104",
pages = "64--73",
journal = "British Journal of Ophthalmology",
issn = "0007-1161",
publisher = "BMJ Publishing Group",
number = "1",

}

TY - JOUR

T1 - Safety and tolerability of ranibizumab in uni/bilateral neovascular age-related macular degeneration

T2 - 12-month TWEYEs study

AU - Bandello, Francesco

AU - Staurenghi, Giovanni

AU - Ricci, Federico

AU - Midena, Edoardo

AU - Viola, Francesco

AU - Lupieri Sinibaldi, Tommaso

AU - Colombo, Laura

AU - Peruzzi, Elena

AU - Bassanini, Stefania

PY - 2020

Y1 - 2020

N2 - 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.

AB - 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.

KW - age-related macular degeneration

KW - bilateral AMD

KW - neovascular age-related macular degeneration

KW - neovascularisation

KW - retina

KW - unilateral AMD

KW - vision

UR - http://www.scopus.com/inward/record.url?scp=85065576453&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85065576453&partnerID=8YFLogxK

U2 - 10.1136/bjophthalmol-2019-313907

DO - 10.1136/bjophthalmol-2019-313907

M3 - Article

AN - SCOPUS:85065576453

VL - 104

SP - 64

EP - 73

JO - British Journal of Ophthalmology

JF - British Journal of Ophthalmology

SN - 0007-1161

IS - 1

ER -