Intravitreal fluocinolone acetonide 0.19 mg (ILUVIEN®) in patients with non-infectious uveitis: real-world effectiveness and safety outcomes at 12 months

Purpose: This study assessed the effectiveness of the 0.19-mg fluocinolone acetonide (FAc) implant by multimodal measurements in patients with non-infectious uveitis (NIU) in a real-world setting in Spain. Methods: A prospective study of patients who had NIU including uveitic macular oedema (UME) wi...

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Autores: Moll Udina, Aina, Hernanz, Inés, Sainz de la Maza Serra, María Teresa, Pelegrín, Laura, Coelho Borges, Ana Isabel, Pazos, Marta, Adán Civera, Alfredo, Llorenç, Victor
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:2445/217644
Acceso en línea:https://hdl.handle.net/2445/217644
Access Level:acceso abierto
Palabra clave:Infeccions oculars
Uveïtis
Retinopatia diabètica
Glaucoma
Eye infections
Uveitis
Diabetic retinopathy
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spelling Intravitreal fluocinolone acetonide 0.19 mg (ILUVIEN®) in patients with non-infectious uveitis: real-world effectiveness and safety outcomes at 12 monthsMoll Udina, AinaHernanz, InésSainz de la Maza Serra, María TeresaPelegrín, LauraCoelho Borges, Ana IsabelPazos, MartaAdán Civera, AlfredoLlorenç, VictorInfeccions ocularsUveïtisRetinopatia diabèticaGlaucomaEye infectionsUveitisDiabetic retinopathyGlaucomaPurpose: This study assessed the effectiveness of the 0.19-mg fluocinolone acetonide (FAc) implant by multimodal measurements in patients with non-infectious uveitis (NIU) in a real-world setting in Spain. Methods: A prospective study of patients who had NIU including uveitic macular oedema (UME) with ≥ 12 months follow-up was done. Exclusion criteria include infectious uveitis and uncontrolled glaucoma or ocular hypertension requiring more than 2 medications. Effectiveness was assessed using a multicomponent outcome measure that included nine outcomes. Effectiveness was defined as all components being met at every timepoint. Secondary outcome measures were onset or progression of glaucoma and investigator-reported adverse events. Results: Twenty-six eyes from 22 patients were included, with 96.2% having an indication including UME. During the 12-month study, the FAc implant was effective in 15 (57.7%) eyes, reaching effectiveness as soon as 2 weeks post-implantation. Mean best-corrected visual acuity and mean central macular thickness (CMT) were significantly improved vs. baseline at all timepoints (all comparisons p < 0.01). During the 12-month study, inflammation markers (anterior chamber cells and vitreous haze) had also significantly declined. Factors predicting effectiveness at month 12 were systemic corticosteroid dose pre-FAc, higher immunomodulatory therapy (IMT) load at baseline and thicker retinal nerve fibre layer (RNFL) at baseline (all p < 0.05). Factors predicting failure were male gender, thinner RNFL at baseline and treatment ineffectiveness at 1 month (all p < 0.05). In parallel, corticosteroid and IMT use also declined significantly. No significant increase in IOP was detected. Conclusion: The FAc implant is safe and effective at treating NIU over 12 months in a real-world setting in Spain.Springer Verlag2025202520232025info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion15 p.application/pdfhttps://hdl.handle.net/2445/217644Articles publicats en revistes (Cirurgia i Especialitats Medicoquirúrgiques)reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésReproducció del document publicat a: https://doi.org/10.1007/s10792-023-02828-6International Ophthalmology, 2023, vol. 43, num.11, p. 4181-4195https://doi.org/10.1007/s10792-023-02828-6cc-by (c) Moll Udina, Aina et al., 2023http://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:2445/2176442026-05-29T05:05:01Z
dc.title.none.fl_str_mv Intravitreal fluocinolone acetonide 0.19 mg (ILUVIEN®) in patients with non-infectious uveitis: real-world effectiveness and safety outcomes at 12 months
title Intravitreal fluocinolone acetonide 0.19 mg (ILUVIEN®) in patients with non-infectious uveitis: real-world effectiveness and safety outcomes at 12 months
spellingShingle Intravitreal fluocinolone acetonide 0.19 mg (ILUVIEN®) in patients with non-infectious uveitis: real-world effectiveness and safety outcomes at 12 months
Moll Udina, Aina
Infeccions oculars
Uveïtis
Retinopatia diabètica
Glaucoma
Eye infections
Uveitis
Diabetic retinopathy
Glaucoma
title_short Intravitreal fluocinolone acetonide 0.19 mg (ILUVIEN®) in patients with non-infectious uveitis: real-world effectiveness and safety outcomes at 12 months
title_full Intravitreal fluocinolone acetonide 0.19 mg (ILUVIEN®) in patients with non-infectious uveitis: real-world effectiveness and safety outcomes at 12 months
title_fullStr Intravitreal fluocinolone acetonide 0.19 mg (ILUVIEN®) in patients with non-infectious uveitis: real-world effectiveness and safety outcomes at 12 months
title_full_unstemmed Intravitreal fluocinolone acetonide 0.19 mg (ILUVIEN®) in patients with non-infectious uveitis: real-world effectiveness and safety outcomes at 12 months
title_sort Intravitreal fluocinolone acetonide 0.19 mg (ILUVIEN®) in patients with non-infectious uveitis: real-world effectiveness and safety outcomes at 12 months
dc.creator.none.fl_str_mv Moll Udina, Aina
Hernanz, Inés
Sainz de la Maza Serra, María Teresa
Pelegrín, Laura
Coelho Borges, Ana Isabel
Pazos, Marta
Adán Civera, Alfredo
Llorenç, Victor
author Moll Udina, Aina
author_facet Moll Udina, Aina
Hernanz, Inés
Sainz de la Maza Serra, María Teresa
Pelegrín, Laura
Coelho Borges, Ana Isabel
Pazos, Marta
Adán Civera, Alfredo
Llorenç, Victor
author_role author
author2 Hernanz, Inés
Sainz de la Maza Serra, María Teresa
Pelegrín, Laura
Coelho Borges, Ana Isabel
Pazos, Marta
Adán Civera, Alfredo
Llorenç, Victor
author2_role author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Infeccions oculars
Uveïtis
Retinopatia diabètica
Glaucoma
Eye infections
Uveitis
Diabetic retinopathy
Glaucoma
topic Infeccions oculars
Uveïtis
Retinopatia diabètica
Glaucoma
Eye infections
Uveitis
Diabetic retinopathy
Glaucoma
description Purpose: This study assessed the effectiveness of the 0.19-mg fluocinolone acetonide (FAc) implant by multimodal measurements in patients with non-infectious uveitis (NIU) in a real-world setting in Spain. Methods: A prospective study of patients who had NIU including uveitic macular oedema (UME) with ≥ 12 months follow-up was done. Exclusion criteria include infectious uveitis and uncontrolled glaucoma or ocular hypertension requiring more than 2 medications. Effectiveness was assessed using a multicomponent outcome measure that included nine outcomes. Effectiveness was defined as all components being met at every timepoint. Secondary outcome measures were onset or progression of glaucoma and investigator-reported adverse events. Results: Twenty-six eyes from 22 patients were included, with 96.2% having an indication including UME. During the 12-month study, the FAc implant was effective in 15 (57.7%) eyes, reaching effectiveness as soon as 2 weeks post-implantation. Mean best-corrected visual acuity and mean central macular thickness (CMT) were significantly improved vs. baseline at all timepoints (all comparisons p < 0.01). During the 12-month study, inflammation markers (anterior chamber cells and vitreous haze) had also significantly declined. Factors predicting effectiveness at month 12 were systemic corticosteroid dose pre-FAc, higher immunomodulatory therapy (IMT) load at baseline and thicker retinal nerve fibre layer (RNFL) at baseline (all p < 0.05). Factors predicting failure were male gender, thinner RNFL at baseline and treatment ineffectiveness at 1 month (all p < 0.05). In parallel, corticosteroid and IMT use also declined significantly. No significant increase in IOP was detected. Conclusion: The FAc implant is safe and effective at treating NIU over 12 months in a real-world setting in Spain.
publishDate 2023
dc.date.none.fl_str_mv 2023
2025
2025
2025
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/217644
url https://hdl.handle.net/2445/217644
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1007/s10792-023-02828-6
International Ophthalmology, 2023, vol. 43, num.11, p. 4181-4195
https://doi.org/10.1007/s10792-023-02828-6
dc.rights.none.fl_str_mv cc-by (c) Moll Udina, Aina et al., 2023
http://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc-by (c) Moll Udina, Aina et al., 2023
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 15 p.
application/pdf
dc.publisher.none.fl_str_mv Springer Verlag
publisher.none.fl_str_mv Springer Verlag
dc.source.none.fl_str_mv Articles publicats en revistes (Cirurgia i Especialitats Medicoquirúrgiques)
reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,812429

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