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...
| Authors: | ; ; ; ; ; ; ; |
|---|---|
| Format: | Article |
| Status: | Published version |
| Publication date: | 2023 |
| Country: | España |
| Institution: | Universidad de Barcelona |
| Repository: | Dipòsit Digital de la UB |
| OAI Identifier: | oai:diposit.ub.edu:2445/217644 |
| Online Access: | https://hdl.handle.net/2445/217644 |
| Access Level: | Open access |
| Keyword: | Infeccions oculars Uveïtis Retinopatia diabètica Glaucoma Eye infections Uveitis Diabetic retinopathy |
| _version_ | 1878733150300930048 |
|---|---|
| author | Moll Udina, Aina |
| 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 |
| author_browse | Adán Civera, Alfredo Coelho Borges, Ana Isabel Hernanz, Inés Llorenç, Victor Moll Udina, Aina Pazos, Marta Pelegrín, Laura Sainz de la Maza Serra, María Teresa |
| 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 |
| collection | Dipòsit Digital de la UB |
| 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. |
| eu_rights_str_mv | openAccess |
| format | article |
| id | ES_50f7f8a82935eb7aafb5d0cd2cfa4258 |
| institution | Universidad de Barcelona |
| instname_str | Universidad de Barcelona |
| network_acronym_str | ES |
| network_name_str | España |
| oai_identifier_str | oai:diposit.ub.edu:2445/217644 |
| publishDate | 2023 |
| publishDateSort | 2023 |
| publisher | Springer Verlag |
| publisherStr | Springer Verlag |
| reponame_str | Dipòsit Digital de la UB |
| spelling | 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 Hernanz, Inés Sainz de la Maza Serra, María Teresa Pelegrín, Laura Coelho Borges, Ana Isabel Pazos, Marta Adán Civera, Alfredo Llorenç, Victor Infeccions oculars Uveïtis Retinopatia diabètica Glaucoma Eye infections Uveitis Diabetic retinopathy 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. Springer Verlag https://hdl.handle.net/2445/217644 |
| 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 |
| status_str | publishedVersion |
| title | 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_short | 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 |
| topic | Infeccions oculars Uveïtis Retinopatia diabètica Glaucoma Eye infections Uveitis Diabetic retinopathy |
| topic_facet | Infeccions oculars Uveïtis Retinopatia diabètica Glaucoma Eye infections Uveitis Diabetic retinopathy |
| url | https://hdl.handle.net/2445/217644 |