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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
Main Authors: 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
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creator Yang, Y
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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
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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 &amp; dosage ; Diabetic Retinopathy - drug therapy ; Drug Implants ; Female ; Fluocinolone Acetonide - administration &amp; dosage ; Follow-Up Studies ; Glucocorticoids - administration &amp; dosage ; Humans ; Laboratory Medicine ; Macular Edema - drug therapy ; Male ; Medicine ; Medicine &amp; 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 &amp; dosage</subject><subject>Diabetic Retinopathy - drug therapy</subject><subject>Drug Implants</subject><subject>Female</subject><subject>Fluocinolone Acetonide - administration &amp; dosage</subject><subject>Follow-Up Studies</subject><subject>Glucocorticoids - administration &amp; dosage</subject><subject>Humans</subject><subject>Laboratory Medicine</subject><subject>Macular Edema - drug therapy</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine &amp; 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 ; 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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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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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