Three-year patient-reported visual function outcomes in diabetic macular edema managed with ranibizumab: the RESTORE extension study.
Identifieur interne : 002791 ( PubMed/Corpus ); précédent : 002790; suivant : 002792Three-year patient-reported visual function outcomes in diabetic macular edema managed with ranibizumab: the RESTORE extension study.
Auteurs : Paul Mitchell ; Pascale Massin ; Susan Bressler ; Cheryl D. Coon ; Jennifer Petrillo ; Alberto Ferreira ; Neil M. BresslerSource :
- Current medical research and opinion [ 1473-4877 ] ; 2015.
English descriptors
- KwdEn :
- Aged, Angiogenesis Inhibitors (administration & dosage), Angiogenesis Inhibitors (therapeutic use), Combined Modality Therapy, Diabetic Retinopathy (drug therapy), Female, Humans, Macular Edema (drug therapy), Male, Middle Aged, Ranibizumab (administration & dosage), Surveys and Questionnaires, Visual Acuity.
- MESH :
- chemical , administration & dosage : Angiogenesis Inhibitors, Ranibizumab.
- chemical , therapeutic use : Angiogenesis Inhibitors.
- drug therapy : Diabetic Retinopathy, Macular Edema.
- Aged, Combined Modality Therapy, Female, Humans, Male, Middle Aged, Surveys and Questionnaires, Visual Acuity.
Abstract
To determine the impact of ranibizumab 0.5 mg on patient-reported visual function over 36 months in individuals with visual impairment from diabetic macular edema.
DOI: 10.1185/03007995.2015.1081880
PubMed: 26327116
Links to Exploration step
pubmed:26327116Le document en format XML
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Coon</name><affiliation><nlm:affiliation>d d Outcometrix , Tucson , AZ , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Petrillo, Jennifer" sort="Petrillo, Jennifer" uniqKey="Petrillo J" first="Jennifer" last="Petrillo">Jennifer Petrillo</name><affiliation><nlm:affiliation>e e Novartis Pharma AG , Basel , Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Ferreira, Alberto" sort="Ferreira, Alberto" uniqKey="Ferreira A" first="Alberto" last="Ferreira">Alberto Ferreira</name><affiliation><nlm:affiliation>e e Novartis Pharma AG , Basel , Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Bressler, Neil M" sort="Bressler, Neil M" uniqKey="Bressler N" first="Neil M" last="Bressler">Neil M. Bressler</name><affiliation><nlm:affiliation>c c Retina Division , Wilmer Eye Institute, Johns Hopkins University School of Medicine , Baltimore , MD , USA.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:26327116</idno><idno type="pmid">26327116</idno><idno type="doi">10.1185/03007995.2015.1081880</idno><idno type="wicri:Area/PubMed/Corpus">002791</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">002791</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Three-year patient-reported visual function outcomes in diabetic macular edema managed with ranibizumab: the RESTORE extension study.</title><author><name sortKey="Mitchell, Paul" sort="Mitchell, Paul" uniqKey="Mitchell P" first="Paul" last="Mitchell">Paul Mitchell</name><affiliation><nlm:affiliation>a a Department of Ophthalmology and Westmead Millennium Institute , University of Sydney , Sydney , Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Massin, Pascale" sort="Massin, Pascale" uniqKey="Massin P" first="Pascale" last="Massin">Pascale Massin</name><affiliation><nlm:affiliation>b b Service d'Ophtalmologie, Hôpital Lariboisière APHP, Université Paris Diderot , Paris , France.</nlm:affiliation></affiliation></author><author><name sortKey="Bressler, Susan" sort="Bressler, Susan" uniqKey="Bressler S" first="Susan" last="Bressler">Susan Bressler</name><affiliation><nlm:affiliation>c c Retina Division , Wilmer Eye Institute, Johns Hopkins University School of Medicine , Baltimore , MD , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Coon, Cheryl D" sort="Coon, Cheryl D" uniqKey="Coon C" first="Cheryl D" last="Coon">Cheryl D. Coon</name><affiliation><nlm:affiliation>d d Outcometrix , Tucson , AZ , USA.</nlm:affiliation></affiliation></author><author><name sortKey="Petrillo, Jennifer" sort="Petrillo, Jennifer" uniqKey="Petrillo J" first="Jennifer" last="Petrillo">Jennifer Petrillo</name><affiliation><nlm:affiliation>e e Novartis Pharma AG , Basel , Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Ferreira, Alberto" sort="Ferreira, Alberto" uniqKey="Ferreira A" first="Alberto" last="Ferreira">Alberto Ferreira</name><affiliation><nlm:affiliation>e e Novartis Pharma AG , Basel , Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Bressler, Neil M" sort="Bressler, Neil M" uniqKey="Bressler N" first="Neil M" last="Bressler">Neil M. Bressler</name><affiliation><nlm:affiliation>c c Retina Division , Wilmer Eye Institute, Johns Hopkins University School of Medicine , Baltimore , MD , USA.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Current medical research and opinion</title><idno type="eISSN">1473-4877</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Angiogenesis Inhibitors (administration & dosage)</term><term>Angiogenesis Inhibitors (therapeutic use)</term><term>Combined Modality Therapy</term><term>Diabetic Retinopathy (drug therapy)</term><term>Female</term><term>Humans</term><term>Macular Edema (drug therapy)</term><term>Male</term><term>Middle Aged</term><term>Ranibizumab (administration & dosage)</term><term>Surveys and Questionnaires</term><term>Visual Acuity</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Angiogenesis Inhibitors</term><term>Ranibizumab</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Angiogenesis Inhibitors</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Diabetic Retinopathy</term><term>Macular Edema</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Combined Modality Therapy</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Surveys and Questionnaires</term><term>Visual Acuity</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">To determine the impact of ranibizumab 0.5 mg on patient-reported visual function over 36 months in individuals with visual impairment from diabetic macular edema.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26327116</PMID><DateCreated><Year>2015</Year><Month>11</Month><Day>11</Day></DateCreated><DateCompleted><Year>2016</Year><Month>06</Month><Day>08</Day></DateCompleted><DateRevised><Year>2015</Year><Month>11</Month><Day>11</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1473-4877</ISSN><JournalIssue CitedMedium="Internet"><Volume>31</Volume><Issue>11</Issue><PubDate><Year>2015</Year><Month>Nov</Month></PubDate></JournalIssue><Title>Current medical research and opinion</Title><ISOAbbreviation>Curr Med Res Opin</ISOAbbreviation></Journal><ArticleTitle>Three-year patient-reported visual function outcomes in diabetic macular edema managed with ranibizumab: the RESTORE extension study.</ArticleTitle><Pagination><MedlinePgn>1967-75</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1185/03007995.2015.1081880</ELocationID><Abstract><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">To determine the impact of ranibizumab 0.5 mg on patient-reported visual function over 36 months in individuals with visual impairment from diabetic macular edema.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">RESTORE comprises a phase 3, randomized, multicenter, 12 month core study and a 24 month open-label extension study. Eyes assigned to ranibizumab in the core study received ranibizumab for 36 months; eyes assigned to laser monotherapy in the core study received ranibizumab during the extension. The primary outcome was least-squares mean change in National Eye Institute 25-item Visual Functioning Questionnaire (NEI VFQ-25) overall composite and subscale scores.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Of 303 core study participants, 240 (79%) entered the extension, comprising 83 (35%) participants initially assigned to ranibizumab, 83 (35%) assigned to ranibizumab plus laser combination therapy, and 74 (31%) assigned to laser monotherapy. Least-squares mean (standard error) change in NEI VFQ-25 composite score from baseline to month 12 (+5.9 [1.5]; +5.0 [1.5], for the ranibizumab and combination therapy groups, respectively) decreased by month 36 (+4.1 [1.7]; +4.0 [1.7], respectively, from baseline to month 36) following reduced injection frequency relative to the core study. At 36 months, the least-squares mean (standard error) change in the laser monotherapy group was similar to that in the ranibizumab groups (+4.1 [1.8]). Most subscale scores showed outcomes similar to that for the composite score. The greatest NEI VFQ-25 gains were consistently observed in participants for whom the study eye was the better-seeing eye.</AbstractText><AbstractText Label="LIMITATIONS" NlmCategory="CONCLUSIONS">Patients entering the extension were not randomized, and 21% of the core study participants did not enter the extension, which may have affected the results.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Gains in patient-reported visual function at month 12 among eyes receiving ranibizumab in the core study decreased slightly by 36 months. Eyes originally receiving laser monotherapy for 12 months then ranibizumab for 24 months achieved similar gains by 36 months to eyes receiving ranibizumab for 36 months.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">ClinicalTrials.gov: NCT00687804 and NCT00906464.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Mitchell</LastName><ForeName>Paul</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>a a Department of Ophthalmology and Westmead Millennium Institute , University of Sydney , Sydney , Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Massin</LastName><ForeName>Pascale</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>b b Service d'Ophtalmologie, Hôpital Lariboisière APHP, Université Paris Diderot , Paris , France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bressler</LastName><ForeName>Susan</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>c c Retina Division , Wilmer Eye Institute, Johns Hopkins University School of Medicine , Baltimore , MD , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Coon</LastName><ForeName>Cheryl D</ForeName><Initials>CD</Initials><AffiliationInfo><Affiliation>d d Outcometrix , Tucson , AZ , USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Petrillo</LastName><ForeName>Jennifer</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>e e Novartis Pharma AG , Basel , Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ferreira</LastName><ForeName>Alberto</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>e e Novartis Pharma AG , Basel , Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bressler</LastName><ForeName>Neil M</ForeName><Initials>NM</Initials><AffiliationInfo><Affiliation>c c Retina Division , Wilmer Eye Institute, Johns Hopkins University School of Medicine , Baltimore , MD , USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00687804</AccessionNumber><AccessionNumber>NCT00906464</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>10</Month><Day>06</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Curr Med Res Opin</MedlineTA><NlmUniqueID>0351014</NlmUniqueID><ISSNLinking>0300-7995</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D020533">Angiogenesis Inhibitors</NameOfSubstance></Chemical><Chemical><RegistryNumber>ZL1R02VT79</RegistryNumber><NameOfSubstance UI="D000069579">Ranibizumab</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D020533" MajorTopicYN="N">Angiogenesis Inhibitors</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D003131" MajorTopicYN="N">Combined Modality Therapy</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D003930" MajorTopicYN="N">Diabetic Retinopathy</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008269" MajorTopicYN="N">Macular Edema</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000069579" MajorTopicYN="N">Ranibizumab</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011795" MajorTopicYN="N">Surveys and Questionnaires</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014792" MajorTopicYN="N">Visual Acuity</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Diabetic retinopathy</Keyword><Keyword MajorTopicYN="N">Macular edema</Keyword><Keyword MajorTopicYN="N">Ranibizumab</Keyword><Keyword MajorTopicYN="N">Retina</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>9</Month><Day>2</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2015</Year><Month>9</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>6</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">26327116</ArticleId><ArticleId IdType="doi">10.1185/03007995.2015.1081880</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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