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

Holz FG, Bandello F, Gillies M, Mitchell P, Osborne A, Sheidow T, Souied E, Figueroa MS, LUMINOUS Steering Committ - Br J Ophthalmol (2013)

Bottom Line: Evaluation of 1-year safety profile of intravitreal ranibizumab 0.5 mg in neovascular age-related macular degeneration (NV-AMD) within routine clinical practice.Most frequent overall ocular events of particular interest were retinal pigment epithelial tears (27 patients; <1%) and intraocular pressure-related events (12 patients; <0.3%).Most frequent non-ocular event of particular interest was stroke (19 patients; 0.4%); annual incidence of stroke was low across all registries (0.0-0.5%).

View Article: PubMed Central - PubMed

Affiliation: Department of Ophthalmology, University of Bonn, Germany. Frank.Holz@ukb.uni-bonn.de

ABSTRACT

Purpose: Evaluation of 1-year safety profile of intravitreal ranibizumab 0.5 mg in neovascular age-related 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; <1%) and intraocular pressure-related events (12 patients; <0.3%). Most frequent non-ocular event of particular interest was stroke (19 patients; 0.4%); annual incidence of stroke was low across all registries (0.0-0.5%).

Conclusions: Ranibizumab demonstrated favourable 1-year safety profile for NV-AMD in this routine clinical practice sample, consistent with previous reported trial data. Additional data from a larger patient population are needed to better describe the long-term safety profile of ranibizumab in routine clinical practice and further evaluate risk for infrequent but serious events in 'real-life' settings. The 5-year LUMINOUS prospective observational study will address this need.

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Related in: MedlinePlus

Timeline of the European registries included in the pooled analysis. Retreatment criteria were based on the European Summary of Product Characteristics during this period (>5 letter loss). The German and Swedish registries were both 1-year studies with safety among the primary objectives.1314 The HELIOS studies (the Netherlands and Belgium) were 2-year studies with a primary objective to describe visual acuity outcomes over the 2-year observation period; the evaluation of the safety of ranibizumab in real life over 2 years was a secondary objective.15 16 For both HELIOS studies an interim analysis was planned once all patients had their 1-year assessment. NV-AMD, neovascular age-related macular degeneration.
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BJOPHTHALMOL2013303232F1: Timeline of the European registries included in the pooled analysis. Retreatment criteria were based on the European Summary of Product Characteristics during this period (>5 letter loss). The German and Swedish registries were both 1-year studies with safety among the primary objectives.1314 The HELIOS studies (the Netherlands and Belgium) were 2-year studies with a primary objective to describe visual acuity outcomes over the 2-year observation period; the evaluation of the safety of ranibizumab in real life over 2 years was a secondary objective.15 16 For both HELIOS studies an interim analysis was planned once all patients had their 1-year assessment. NV-AMD, neovascular age-related macular degeneration.

Mentions: A retrospective analysis of pooled 1-year ranibizumab safety data from four completed ranibizumab NV-AMD registries in Europe was conducted. Included registries were those completed or with interim 1-year analysis at the time of this analysis (September 2011) (figure 1). Data were obtained from medical records of patients treated in Germany (N=3470), the Netherlands (N=243), Belgium (N=260) and Sweden (N=471). A complete list of study sites from each registry is provided in the online supplementary table S1.


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

Holz FG, Bandello F, Gillies M, Mitchell P, Osborne A, Sheidow T, Souied E, Figueroa MS, LUMINOUS Steering Committ - Br J Ophthalmol (2013)

Timeline of the European registries included in the pooled analysis. Retreatment criteria were based on the European Summary of Product Characteristics during this period (>5 letter loss). The German and Swedish registries were both 1-year studies with safety among the primary objectives.1314 The HELIOS studies (the Netherlands and Belgium) were 2-year studies with a primary objective to describe visual acuity outcomes over the 2-year observation period; the evaluation of the safety of ranibizumab in real life over 2 years was a secondary objective.15 16 For both HELIOS studies an interim analysis was planned once all patients had their 1-year assessment. NV-AMD, neovascular age-related macular degeneration.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3756427&req=5

BJOPHTHALMOL2013303232F1: Timeline of the European registries included in the pooled analysis. Retreatment criteria were based on the European Summary of Product Characteristics during this period (>5 letter loss). The German and Swedish registries were both 1-year studies with safety among the primary objectives.1314 The HELIOS studies (the Netherlands and Belgium) were 2-year studies with a primary objective to describe visual acuity outcomes over the 2-year observation period; the evaluation of the safety of ranibizumab in real life over 2 years was a secondary objective.15 16 For both HELIOS studies an interim analysis was planned once all patients had their 1-year assessment. NV-AMD, neovascular age-related macular degeneration.
Mentions: A retrospective analysis of pooled 1-year ranibizumab safety data from four completed ranibizumab NV-AMD registries in Europe was conducted. Included registries were those completed or with interim 1-year analysis at the time of this analysis (September 2011) (figure 1). Data were obtained from medical records of patients treated in Germany (N=3470), the Netherlands (N=243), Belgium (N=260) and Sweden (N=471). A complete list of study sites from each registry is provided in the online supplementary table S1.

Bottom Line: Evaluation of 1-year safety profile of intravitreal ranibizumab 0.5 mg in neovascular age-related macular degeneration (NV-AMD) within routine clinical practice.Most frequent overall ocular events of particular interest were retinal pigment epithelial tears (27 patients; <1%) and intraocular pressure-related events (12 patients; <0.3%).Most frequent non-ocular event of particular interest was stroke (19 patients; 0.4%); annual incidence of stroke was low across all registries (0.0-0.5%).

View Article: PubMed Central - PubMed

Affiliation: Department of Ophthalmology, University of Bonn, Germany. Frank.Holz@ukb.uni-bonn.de

ABSTRACT

Purpose: Evaluation of 1-year safety profile of intravitreal ranibizumab 0.5 mg in neovascular age-related 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; <1%) and intraocular pressure-related events (12 patients; <0.3%). Most frequent non-ocular event of particular interest was stroke (19 patients; 0.4%); annual incidence of stroke was low across all registries (0.0-0.5%).

Conclusions: Ranibizumab demonstrated favourable 1-year safety profile for NV-AMD in this routine clinical practice sample, consistent with previous reported trial data. Additional data from a larger patient population are needed to better describe the long-term safety profile of ranibizumab in routine clinical practice and further evaluate risk for infrequent but serious events in 'real-life' settings. The 5-year LUMINOUS prospective observational study will address this need.

Show MeSH
Related in: MedlinePlus