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Long-term outcomes of phakic patients with diabetic macular oedema treated with intravitreal fluocinolone acetonide (FAc) implants
Purpose Diabetic macular oedema (DMO) is a leading cause of blindness in working-age adults. Slow-release, nonbioerodible fluocinolone acetonide (FAc) implants have shown efficacy in the treatment of DMO; however, the National Institute for Health and Care Excellence recommends that FAc should be us...
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Published in: | Eye (London) 2015-09, Vol.29 (9), p.1173-1180 |
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creator | Yang, Y Bailey, C Holz, F G Eter, N Weber, M Baker, C Kiss, S Menchini, U Ruiz Moreno, J M Dugel, P Lotery, A |
description | Purpose
Diabetic macular oedema (DMO) is a leading cause of blindness in working-age adults. Slow-release, nonbioerodible fluocinolone acetonide (FAc) implants have shown efficacy in the treatment of DMO; however, the National Institute for Health and Care Excellence recommends that FAc should be used in patients with chronic DMO considered insufficiently responsive to other available therapies only if the eye to be treated is pseudophakic. The goal of this analysis was to examine treatment outcomes in phakic patients who received 0.2
μ
g/day FAc implant.
Methods
This analysis of the phase 3 FAME (Fluocinolone Acetonide in Diabetic Macular Edema) data examines the safety and efficacy of FAc implants in patients who underwent cataract extraction before (cataract before implant (CBI) group) or after (cataract after implant (CAI) group) receiving the implant. The data were further examined by DMO duration.
Results
Best corrected visual acuity (BCVA) after 36 months was comparable in the CAI and CBI groups. Both the percentage of patients gaining ≥3 lines of vision and mean change in BCVA letter score were numerically greater in the CAI group. In addition, most patients who underwent cataract surgery experienced a net gain in BCVA from presurgery baseline as well as from original study baseline.
Conclusions
These data support the use of 0.2
μ
g/day FAc implants in phakic as well as in pseudophakic patients. These findings will serve as a pilot for design of future studies to evaluate the potential protective effect of FAc implants before cataract surgery in patients with DMO and cataract. |
doi_str_mv | 10.1038/eye.2015.98 |
format | article |
fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4565956</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1711546655</sourcerecordid><originalsourceid>FETCH-LOGICAL-c479t-aa0de6e284f92f28d9cf7deaeafc2b0daa72a1f7df791712881d0877de0185f73</originalsourceid><addsrcrecordid>eNqNksFrFDEUxgdR7Fo9eZeAl0qdNclOJplLoRRbhQUvCt7C2-RlN3VmsiaZSq_-5WbYWqp48BT4vh9fvpe8qnrJ6JLRlXqHt7jklIllpx5VC9bIthaNaB5XC9oJWnPOvx5Vz1K6prSYkj6tjnjL2ErQ1aL6uQ7jts4YBxKmbMKAiQRH9jv45g3ZQ_Y45kR--Lwj1sMGc5EHMFMPkQS0OADJESGjPUB-zBFu_Kz1xPVTMH4MfRiRgMEcRm-RnFyemzfED_seSvjz6omDPuGLu_O4-nL5_vPFh3r96erjxfm6No3scg1ALbbIVeM67riynXHSIiA4wzfUAkgOrEhOdkwyrhSzVMmCUKaEk6vj6uyQu582A1qDc9Ne76MfIN7qAF7_6Yx-p7fhRjeiFZ1oS8DJXUAM3ydMWQ8-GezLFBimpJlslVCC8-4_UMZE07ZCFPT1X-h1mOJYXmKmaNswxubypwfKxJBSRHffm1E9r4Eua6DnNdCdKvSrh6Pes7__vQBvD0Aq1rjF-ODSf-T9AjVCwAg</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1710641117</pqid></control><display><type>article</type><title>Long-term outcomes of phakic patients with diabetic macular oedema treated with intravitreal fluocinolone acetonide (FAc) implants</title><source>Open Access: PubMed Central</source><creator>Yang, Y ; Bailey, C ; Holz, F G ; Eter, N ; Weber, M ; Baker, C ; Kiss, S ; Menchini, U ; Ruiz Moreno, J M ; Dugel, P ; Lotery, A</creator><creatorcontrib>Yang, Y ; Bailey, C ; Holz, F G ; Eter, N ; Weber, M ; Baker, C ; Kiss, S ; Menchini, U ; Ruiz Moreno, J M ; Dugel, P ; Lotery, A ; FAME study group ; on behalf of the FAME study group</creatorcontrib><description>Purpose
Diabetic macular oedema (DMO) is a leading cause of blindness in working-age adults. Slow-release, nonbioerodible fluocinolone acetonide (FAc) implants have shown efficacy in the treatment of DMO; however, the National Institute for Health and Care Excellence recommends that FAc should be used in patients with chronic DMO considered insufficiently responsive to other available therapies only if the eye to be treated is pseudophakic. The goal of this analysis was to examine treatment outcomes in phakic patients who received 0.2
μ
g/day FAc implant.
Methods
This analysis of the phase 3 FAME (Fluocinolone Acetonide in Diabetic Macular Edema) data examines the safety and efficacy of FAc implants in patients who underwent cataract extraction before (cataract before implant (CBI) group) or after (cataract after implant (CAI) group) receiving the implant. The data were further examined by DMO duration.
Results
Best corrected visual acuity (BCVA) after 36 months was comparable in the CAI and CBI groups. Both the percentage of patients gaining ≥3 lines of vision and mean change in BCVA letter score were numerically greater in the CAI group. In addition, most patients who underwent cataract surgery experienced a net gain in BCVA from presurgery baseline as well as from original study baseline.
Conclusions
These data support the use of 0.2
μ
g/day FAc implants in phakic as well as in pseudophakic patients. These findings will serve as a pilot for design of future studies to evaluate the potential protective effect of FAc implants before cataract surgery in patients with DMO and cataract.</description><identifier>ISSN: 0950-222X</identifier><identifier>EISSN: 1476-5454</identifier><identifier>DOI: 10.1038/eye.2015.98</identifier><identifier>PMID: 26113503</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>692/699/3161/3168 ; 692/699/3161/3175 ; Adult ; Aged ; Clinical Study ; Delayed-Action Preparations - administration & dosage ; Diabetic Retinopathy - drug therapy ; Drug Implants ; Female ; Fluocinolone Acetonide - administration & dosage ; Follow-Up Studies ; Glucocorticoids - administration & dosage ; Humans ; Laboratory Medicine ; Macular Edema - drug therapy ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Ophthalmology ; Pharmaceutical Sciences/Technology ; Pseudophakia - drug therapy ; Surgery ; Surgical Oncology ; Visual Acuity</subject><ispartof>Eye (London), 2015-09, Vol.29 (9), p.1173-1180</ispartof><rights>The Author(s) 2015</rights><rights>Copyright Nature Publishing Group Sep 2015</rights><rights>Copyright © 2015 Royal College of Ophthalmologists 2015 Royal College of Ophthalmologists</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c479t-aa0de6e284f92f28d9cf7deaeafc2b0daa72a1f7df791712881d0877de0185f73</citedby><cites>FETCH-LOGICAL-c479t-aa0de6e284f92f28d9cf7deaeafc2b0daa72a1f7df791712881d0877de0185f73</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4565956/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4565956/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26113503$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yang, Y</creatorcontrib><creatorcontrib>Bailey, C</creatorcontrib><creatorcontrib>Holz, F G</creatorcontrib><creatorcontrib>Eter, N</creatorcontrib><creatorcontrib>Weber, M</creatorcontrib><creatorcontrib>Baker, C</creatorcontrib><creatorcontrib>Kiss, S</creatorcontrib><creatorcontrib>Menchini, U</creatorcontrib><creatorcontrib>Ruiz Moreno, J M</creatorcontrib><creatorcontrib>Dugel, P</creatorcontrib><creatorcontrib>Lotery, A</creatorcontrib><creatorcontrib>FAME study group</creatorcontrib><creatorcontrib>on behalf of the FAME study group</creatorcontrib><title>Long-term outcomes of phakic patients with diabetic macular oedema treated with intravitreal fluocinolone acetonide (FAc) implants</title><title>Eye (London)</title><addtitle>Eye</addtitle><addtitle>Eye (Lond)</addtitle><description>Purpose
Diabetic macular oedema (DMO) is a leading cause of blindness in working-age adults. Slow-release, nonbioerodible fluocinolone acetonide (FAc) implants have shown efficacy in the treatment of DMO; however, the National Institute for Health and Care Excellence recommends that FAc should be used in patients with chronic DMO considered insufficiently responsive to other available therapies only if the eye to be treated is pseudophakic. The goal of this analysis was to examine treatment outcomes in phakic patients who received 0.2
μ
g/day FAc implant.
Methods
This analysis of the phase 3 FAME (Fluocinolone Acetonide in Diabetic Macular Edema) data examines the safety and efficacy of FAc implants in patients who underwent cataract extraction before (cataract before implant (CBI) group) or after (cataract after implant (CAI) group) receiving the implant. The data were further examined by DMO duration.
Results
Best corrected visual acuity (BCVA) after 36 months was comparable in the CAI and CBI groups. Both the percentage of patients gaining ≥3 lines of vision and mean change in BCVA letter score were numerically greater in the CAI group. In addition, most patients who underwent cataract surgery experienced a net gain in BCVA from presurgery baseline as well as from original study baseline.
Conclusions
These data support the use of 0.2
μ
g/day FAc implants in phakic as well as in pseudophakic patients. These findings will serve as a pilot for design of future studies to evaluate the potential protective effect of FAc implants before cataract surgery in patients with DMO and cataract.</description><subject>692/699/3161/3168</subject><subject>692/699/3161/3175</subject><subject>Adult</subject><subject>Aged</subject><subject>Clinical Study</subject><subject>Delayed-Action Preparations - administration & dosage</subject><subject>Diabetic Retinopathy - drug therapy</subject><subject>Drug Implants</subject><subject>Female</subject><subject>Fluocinolone Acetonide - administration & dosage</subject><subject>Follow-Up Studies</subject><subject>Glucocorticoids - administration & dosage</subject><subject>Humans</subject><subject>Laboratory Medicine</subject><subject>Macular Edema - drug therapy</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Ophthalmology</subject><subject>Pharmaceutical Sciences/Technology</subject><subject>Pseudophakia - drug therapy</subject><subject>Surgery</subject><subject>Surgical Oncology</subject><subject>Visual Acuity</subject><issn>0950-222X</issn><issn>1476-5454</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><recordid>eNqNksFrFDEUxgdR7Fo9eZeAl0qdNclOJplLoRRbhQUvCt7C2-RlN3VmsiaZSq_-5WbYWqp48BT4vh9fvpe8qnrJ6JLRlXqHt7jklIllpx5VC9bIthaNaB5XC9oJWnPOvx5Vz1K6prSYkj6tjnjL2ErQ1aL6uQ7jts4YBxKmbMKAiQRH9jv45g3ZQ_Y45kR--Lwj1sMGc5EHMFMPkQS0OADJESGjPUB-zBFu_Kz1xPVTMH4MfRiRgMEcRm-RnFyemzfED_seSvjz6omDPuGLu_O4-nL5_vPFh3r96erjxfm6No3scg1ALbbIVeM67riynXHSIiA4wzfUAkgOrEhOdkwyrhSzVMmCUKaEk6vj6uyQu582A1qDc9Ne76MfIN7qAF7_6Yx-p7fhRjeiFZ1oS8DJXUAM3ydMWQ8-GezLFBimpJlslVCC8-4_UMZE07ZCFPT1X-h1mOJYXmKmaNswxubypwfKxJBSRHffm1E9r4Eua6DnNdCdKvSrh6Pes7__vQBvD0Aq1rjF-ODSf-T9AjVCwAg</recordid><startdate>20150901</startdate><enddate>20150901</enddate><creator>Yang, Y</creator><creator>Bailey, C</creator><creator>Holz, F G</creator><creator>Eter, N</creator><creator>Weber, M</creator><creator>Baker, C</creator><creator>Kiss, S</creator><creator>Menchini, U</creator><creator>Ruiz Moreno, J M</creator><creator>Dugel, P</creator><creator>Lotery, A</creator><general>Nature Publishing Group UK</general><general>Nature Publishing Group</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7TK</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M7P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>7QO</scope><scope>8FD</scope><scope>FR3</scope><scope>P64</scope><scope>5PM</scope></search><sort><creationdate>20150901</creationdate><title>Long-term outcomes of phakic patients with diabetic macular oedema treated with intravitreal fluocinolone acetonide (FAc) implants</title><author>Yang, Y ; Bailey, C ; Holz, F G ; Eter, N ; Weber, M ; Baker, C ; Kiss, S ; Menchini, U ; Ruiz Moreno, J M ; Dugel, P ; Lotery, A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c479t-aa0de6e284f92f28d9cf7deaeafc2b0daa72a1f7df791712881d0877de0185f73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>692/699/3161/3168</topic><topic>692/699/3161/3175</topic><topic>Adult</topic><topic>Aged</topic><topic>Clinical Study</topic><topic>Delayed-Action Preparations - administration & dosage</topic><topic>Diabetic Retinopathy - drug therapy</topic><topic>Drug Implants</topic><topic>Female</topic><topic>Fluocinolone Acetonide - administration & dosage</topic><topic>Follow-Up Studies</topic><topic>Glucocorticoids - administration & dosage</topic><topic>Humans</topic><topic>Laboratory Medicine</topic><topic>Macular Edema - drug therapy</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Ophthalmology</topic><topic>Pharmaceutical Sciences/Technology</topic><topic>Pseudophakia - drug therapy</topic><topic>Surgery</topic><topic>Surgical Oncology</topic><topic>Visual Acuity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yang, Y</creatorcontrib><creatorcontrib>Bailey, C</creatorcontrib><creatorcontrib>Holz, F G</creatorcontrib><creatorcontrib>Eter, N</creatorcontrib><creatorcontrib>Weber, M</creatorcontrib><creatorcontrib>Baker, C</creatorcontrib><creatorcontrib>Kiss, S</creatorcontrib><creatorcontrib>Menchini, U</creatorcontrib><creatorcontrib>Ruiz Moreno, J M</creatorcontrib><creatorcontrib>Dugel, P</creatorcontrib><creatorcontrib>Lotery, A</creatorcontrib><creatorcontrib>FAME study group</creatorcontrib><creatorcontrib>on behalf of the FAME study group</creatorcontrib><collection>SpringerOpen</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Neurosciences Abstracts</collection><collection>Health & Medical Complete (ProQuest Database)</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>ProQuest Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection (Proquest) (PQ_SDU_P3)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>ProQuest Biological Science Journals</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>Biotechnology Research Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Eye (London)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yang, Y</au><au>Bailey, C</au><au>Holz, F G</au><au>Eter, N</au><au>Weber, M</au><au>Baker, C</au><au>Kiss, S</au><au>Menchini, U</au><au>Ruiz Moreno, J M</au><au>Dugel, P</au><au>Lotery, A</au><aucorp>FAME study group</aucorp><aucorp>on behalf of the FAME study group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-term outcomes of phakic patients with diabetic macular oedema treated with intravitreal fluocinolone acetonide (FAc) implants</atitle><jtitle>Eye (London)</jtitle><stitle>Eye</stitle><addtitle>Eye (Lond)</addtitle><date>2015-09-01</date><risdate>2015</risdate><volume>29</volume><issue>9</issue><spage>1173</spage><epage>1180</epage><pages>1173-1180</pages><issn>0950-222X</issn><eissn>1476-5454</eissn><abstract>Purpose
Diabetic macular oedema (DMO) is a leading cause of blindness in working-age adults. Slow-release, nonbioerodible fluocinolone acetonide (FAc) implants have shown efficacy in the treatment of DMO; however, the National Institute for Health and Care Excellence recommends that FAc should be used in patients with chronic DMO considered insufficiently responsive to other available therapies only if the eye to be treated is pseudophakic. The goal of this analysis was to examine treatment outcomes in phakic patients who received 0.2
μ
g/day FAc implant.
Methods
This analysis of the phase 3 FAME (Fluocinolone Acetonide in Diabetic Macular Edema) data examines the safety and efficacy of FAc implants in patients who underwent cataract extraction before (cataract before implant (CBI) group) or after (cataract after implant (CAI) group) receiving the implant. The data were further examined by DMO duration.
Results
Best corrected visual acuity (BCVA) after 36 months was comparable in the CAI and CBI groups. Both the percentage of patients gaining ≥3 lines of vision and mean change in BCVA letter score were numerically greater in the CAI group. In addition, most patients who underwent cataract surgery experienced a net gain in BCVA from presurgery baseline as well as from original study baseline.
Conclusions
These data support the use of 0.2
μ
g/day FAc implants in phakic as well as in pseudophakic patients. These findings will serve as a pilot for design of future studies to evaluate the potential protective effect of FAc implants before cataract surgery in patients with DMO and cataract.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>26113503</pmid><doi>10.1038/eye.2015.98</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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source | Open Access: PubMed Central |
subjects | 692/699/3161/3168 692/699/3161/3175 Adult Aged Clinical Study Delayed-Action Preparations - administration & dosage Diabetic Retinopathy - drug therapy Drug Implants Female Fluocinolone Acetonide - administration & dosage Follow-Up Studies Glucocorticoids - administration & dosage Humans Laboratory Medicine Macular Edema - drug therapy Male Medicine Medicine & Public Health Middle Aged Ophthalmology Pharmaceutical Sciences/Technology Pseudophakia - drug therapy Surgery Surgical Oncology Visual Acuity |
title | Long-term outcomes of phakic patients with diabetic macular oedema treated with intravitreal fluocinolone acetonide (FAc) implants |
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