A Nonrandomized, Open-Label, Multicenter, Phase 4 Pilot Study on the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (RESPOND)
Autor(a) principal: | |
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Data de Publicação: | 2017 |
Outros Autores: | , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | http://hdl.handle.net/10400.4/2086 |
Resumo: | 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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A Nonrandomized, Open-Label, Multicenter, Phase 4 Pilot Study on the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (RESPOND)Retinopatia DiabéticaInibidores da AngiogéneseEdema MacularFluocinolona AcetonidaPURPOSE: 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®.RIHUCFigueira, JHenriques, JAmaro, MRosas, VAlves, DCunha-Vaz, J2017-09-01T10:02:14Z20172017-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10400.4/2086engOphthalmic Res. 2017;57(3):166-172. d10.1159/000455235info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-07-11T14:23:24Zoai:rihuc.huc.min-saude.pt:10400.4/2086Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T18:04:33.490132Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
A Nonrandomized, Open-Label, Multicenter, Phase 4 Pilot Study on the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (RESPOND) |
title |
A Nonrandomized, Open-Label, Multicenter, Phase 4 Pilot Study on the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (RESPOND) |
spellingShingle |
A Nonrandomized, Open-Label, Multicenter, Phase 4 Pilot Study on the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (RESPOND) Figueira, J Retinopatia Diabética Inibidores da Angiogénese Edema Macular Fluocinolona Acetonida |
title_short |
A Nonrandomized, Open-Label, Multicenter, Phase 4 Pilot Study on the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (RESPOND) |
title_full |
A Nonrandomized, Open-Label, Multicenter, Phase 4 Pilot Study on the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (RESPOND) |
title_fullStr |
A Nonrandomized, Open-Label, Multicenter, Phase 4 Pilot Study on the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (RESPOND) |
title_full_unstemmed |
A Nonrandomized, Open-Label, Multicenter, Phase 4 Pilot Study on the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (RESPOND) |
title_sort |
A Nonrandomized, Open-Label, Multicenter, Phase 4 Pilot Study on the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (RESPOND) |
author |
Figueira, J |
author_facet |
Figueira, J Henriques, J Amaro, M Rosas, V Alves, D Cunha-Vaz, J |
author_role |
author |
author2 |
Henriques, J Amaro, M Rosas, V Alves, D Cunha-Vaz, J |
author2_role |
author author author author author |
dc.contributor.none.fl_str_mv |
RIHUC |
dc.contributor.author.fl_str_mv |
Figueira, J Henriques, J Amaro, M Rosas, V Alves, D Cunha-Vaz, J |
dc.subject.por.fl_str_mv |
Retinopatia Diabética Inibidores da Angiogénese Edema Macular Fluocinolona Acetonida |
topic |
Retinopatia Diabética Inibidores da Angiogénese Edema Macular Fluocinolona Acetonida |
description |
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®. |
publishDate |
2017 |
dc.date.none.fl_str_mv |
2017-09-01T10:02:14Z 2017 2017-01-01T00:00:00Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/10400.4/2086 |
url |
http://hdl.handle.net/10400.4/2086 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
Ophthalmic Res. 2017;57(3):166-172. d 10.1159/000455235 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
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reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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RCAAP |
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RCAAP |
reponame_str |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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