Safety of ranibizumab in routine clinical practice: 1-year retrospective pooled analysis of four European neovascular AMD registries within the LUMINOUS programme

Frank G. Holz, Francesco Bandello, Mark Gillies, Paul Mitchell, Aaron Osborne, Tom Sheidow, Eric Souied, Marta S. Figueroa, Christopher Brand, Adrian Koh, Ursula Schmidt-Erfurth, N. Sharma, Steve Winyard

Research output: Contribution to journalArticle

Abstract

Purpose: Evaluation of 1-year safety profile of intravitreal ranibizumab 0.5 mg in neovascular agerelated macular degeneration (NV-AMD) within routine clinical practice. Methods: The LUMINOUS programme comprises a prospective observational study assessing ranibizumab 'real-world' safety and clinical effectiveness across licensed indications worldwide and an annual retrospective pooled safety analysis from completed NV-AMD ranibizumab registries. 1-year data from four European registries are available. This retrospective pooled safety analysis assessed 1-year incidence rates for safety events of particular interest (key ocular or systemic events possibly related to the injection procedure or vascular endothelial growth factor inhibition) together with treatment exposure. Patients were treated according to local protocols within the ranibizumab licence. Results: Data of 4444 patients from registries in Germany (n=3470), the Netherlands (n=243), Belgium (n=260) and Sweden (n=471) were retrospectively pooled. Between 70.4% and 84.4% of enrolled patients completed 1 year of follow-up. Most frequent overall ocular events of particular interest were retinal pigment epithelial tears (27 patients;

Original languageEnglish
Pages (from-to)1161-1167
Number of pages7
JournalBritish Journal of Ophthalmology
Volume97
Issue number9
DOIs
Publication statusPublished - Sep 2013

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Registries
Safety
Macular Degeneration
Retinal Pigments
Belgium
Licensure
Tears
Sweden
Netherlands
Vascular Endothelial Growth Factor A
Observational Studies
Germany
Ranibizumab
Prospective Studies
Injections
Incidence
Therapeutics

ASJC Scopus subject areas

  • Ophthalmology
  • Sensory Systems
  • Cellular and Molecular Neuroscience

Cite this

Safety of ranibizumab in routine clinical practice : 1-year retrospective pooled analysis of four European neovascular AMD registries within the LUMINOUS programme. / Holz, Frank G.; Bandello, Francesco; Gillies, Mark; Mitchell, Paul; Osborne, Aaron; Sheidow, Tom; Souied, Eric; Figueroa, Marta S.; Brand, Christopher; Koh, Adrian; Schmidt-Erfurth, Ursula; Sharma, N.; Winyard, Steve.

In: British Journal of Ophthalmology, Vol. 97, No. 9, 09.2013, p. 1161-1167.

Research output: Contribution to journalArticle

Holz, FG, Bandello, F, Gillies, M, Mitchell, P, Osborne, A, Sheidow, T, Souied, E, Figueroa, MS, Brand, C, Koh, A, Schmidt-Erfurth, U, Sharma, N & Winyard, S 2013, 'Safety of ranibizumab in routine clinical practice: 1-year retrospective pooled analysis of four European neovascular AMD registries within the LUMINOUS programme', British Journal of Ophthalmology, vol. 97, no. 9, pp. 1161-1167. https://doi.org/10.1136/bjophthalmol-2013-303232
Holz, Frank G. ; Bandello, Francesco ; Gillies, Mark ; Mitchell, Paul ; Osborne, Aaron ; Sheidow, Tom ; Souied, Eric ; Figueroa, Marta S. ; Brand, Christopher ; Koh, Adrian ; Schmidt-Erfurth, Ursula ; Sharma, N. ; Winyard, Steve. / Safety of ranibizumab in routine clinical practice : 1-year retrospective pooled analysis of four European neovascular AMD registries within the LUMINOUS programme. In: British Journal of Ophthalmology. 2013 ; Vol. 97, No. 9. pp. 1161-1167.
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