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A Nonrandomized, Open-Label, Multicenter, Phase 4 Pilot Study on the Effect and Safety of ILUVIENĀ® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (RESPOND)

dc.contributor.authorFigueira, J
dc.contributor.authorHenriques, J
dc.contributor.authorAmaro, M
dc.contributor.authorRosas, V
dc.contributor.authorAlves, D
dc.contributor.authorCunha-Vaz, J
dc.date.accessioned2017-02-11T20:03:23Z
dc.date.available2017-02-11T20:03:23Z
dc.date.issued2017-02-09
dc.description.abstractPURPOSE: The aim of this study was to assess the effectiveness and safety of ILUVIENĀ® 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 ILUVIENĀ® 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 ILUVIENĀ®. 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 ILUVIENĀ® 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 ILUVIENĀ®.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationOphthalmic Res. 2017 Feb 9. doi: 10.1159/000455235. [Epub ahead of print]pt_PT
dc.identifier.doi10.1159/000455235pt_PT
dc.identifier.urihttp://hdl.handle.net/10400.26/17926
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.subjectRetinopatia DiabƩticapt_PT
dc.subjectEdema Macularpt_PT
dc.subjectInjecƧƵes Intravƭtreaspt_PT
dc.titleA Nonrandomized, Open-Label, Multicenter, Phase 4 Pilot Study on the Effect and Safety of ILUVIENĀ® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (RESPOND)pt_PT
dc.typejournal article
dspace.entity.typePublication
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT

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