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PURPOSE: The aim of this study was to assess the effectiveness and safety of ILUVIEN® in patients with chronic diabetic macular edema (DME) who were insufficiently responsive to prior therapies. METHODS: This is a prospective, nonrandomized, multicenter, open-label, phase 4 pilot study assessing the effectiveness and safety of ILUVIEN® involving 12 patients insufficiently responsive to available therapies. Assessments were performed at screening, baseline, week 1, and months 1, 3, 6, 9, and 12. Demographics, medical/ophthalmic history, prior laser, anti-VEGF, and steroid treatments, and lab tests were recorded at screening. A complete ophthalmic examination and SD-OCT were performed at screening and at all follow-up visits. RESULTS: The patients showed improvements in best-corrected visual acuity (+3.7 letters), with greater improvement among pseudophakic patients (+6.8 letters) compared with phakic patients (-2.5 letters) 12 months after ILUVIEN®. The mean central subfield thickness decrease from baseline to month 12 was statistically significant, with a rapid reduction in the first week. Regarding safety, only 2 patients showed an intraocular pressure (IOP) increase over 25 mm Hg during the study, and the rise in IOP was well managed with eye drops only. CONCLUSIONS: This prospective and pilot study suggests that ILUVIEN® is safe and may be considered effective for chronic DME patients insufficiently responsive to other available therapies as it showed a rapid and sustained improvement of macular edema obtained after treatment with ILUVIEN®.

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Autor(es)

Figueira, J -  Henriques, J -  Amaro, M -  Rosas, V -  Alves, D -  Cunha -  Vaz, J - 

Id.: 69635351

Idioma: eng  - 

Versión: 1.0

Estado: Final

Palabras claveRetinopatia Diabética - 

Tipo de recurso: article  - 

Tipo de Interactividad: Expositivo

Nivel de Interactividad: muy bajo

Audiencia: Estudiante  -  Profesor  -  Autor  - 

Estructura: Atomic

Coste: no

Copyright: sí

: openAccess

Requerimientos técnicos:  Browser: Any - 

Fecha de contribución: 13-feb-2017

Contacto:

Localización:
* Ophthalmic Res. 2017 Feb 9. doi: 10.1159/000455235. [Epub ahead of print]
* 10.1159/000455235

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