Publication
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.author | Figueira, J | |
| dc.contributor.author | Henriques, J | |
| dc.contributor.author | Amaro, M | |
| dc.contributor.author | Rosas, V | |
| dc.contributor.author | Alves, D | |
| dc.contributor.author | Cunha-Vaz, J | |
| dc.date.accessioned | 2017-09-01T10:02:14Z | |
| dc.date.available | 2017-09-01T10:02:14Z | |
| dc.date.issued | 2017 | |
| dc.description.abstract | PURPOSE: 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.version | info:eu-repo/semantics/publishedVersion | pt_PT |
| dc.identifier.citation | Ophthalmic Res. 2017;57(3):166-172. d | pt_PT |
| dc.identifier.doi | 10.1159/000455235 | pt_PT |
| dc.identifier.uri | http://hdl.handle.net/10400.4/2086 | |
| dc.language.iso | eng | pt_PT |
| dc.peerreviewed | yes | pt_PT |
| dc.subject | Retinopatia DiabƩtica | pt_PT |
| dc.subject | Inibidores da AngiogƩnese | pt_PT |
| dc.subject | Edema Macular | pt_PT |
| dc.subject | Fluocinolona Acetonida | pt_PT |
| dc.title | 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) | pt_PT |
| dc.type | journal article | |
| dspace.entity.type | Publication | |
| oaire.citation.endPage | 172 | pt_PT |
| oaire.citation.issue | 3 | pt_PT |
| oaire.citation.startPage | 166-172 | pt_PT |
| oaire.citation.volume | 57 | pt_PT |
| rcaap.rights | openAccess | pt_PT |
| rcaap.type | article | pt_PT |