Scheduled versus Pro Re Nata Dosing in the VIEW Trials.
Identifieur interne : 002C36 ( Ncbi/Merge ); précédent : 002C35; suivant : 002C37Scheduled versus Pro Re Nata Dosing in the VIEW Trials.
Auteurs : Gisbert Richard [Allemagne] ; Jordi Monés [Espagne] ; Sebastian Wolf [Suisse] ; Jean François Korobelnik [France] ; Robyn Guymer [Australie] ; Michaella Goldstein [Israël] ; Christiane Norenberg [Allemagne] ; Rupert Sandbrink [Allemagne] ; Oliver Zeitz [Allemagne]Source :
- Ophthalmology [ 1549-4713 ] ; 2015.
Descripteurs français
- KwdFr :
- Acuité visuelle (physiologie), Adulte d'âge moyen, Angiographie fluorescéinique, Dégénérescence maculaire (diagnostic), Dégénérescence maculaire (physiopathologie), Dégénérescence maculaire (traitement médicamenteux), Facteur de croissance endothéliale vasculaire de type A (antagonistes et inhibiteurs), Femelle, Humains, Inhibiteurs de l'angiogenèse (administration et posologie), Injections intravitréennes, Mâle, Méthode en double aveugle, Protéines de fusion recombinantes (administration et posologie), Ranibizumab (administration et posologie), Reprise du traitement, Récepteurs aux facteurs de croissance endothéliale vasculaire (administration et posologie), Sujet âgé, Sujet âgé de 80 ans ou plus, Tomographie par cohérence optique, Études de suivi, Études rétrospectives.
- MESH :
- administration et posologie : Inhibiteurs de l'angiogenèse, Protéines de fusion recombinantes, Ranibizumab, Récepteurs aux facteurs de croissance endothéliale vasculaire.
- antagonistes et inhibiteurs : Facteur de croissance endothéliale vasculaire de type A.
- diagnostic : Dégénérescence maculaire.
- physiologie : Acuité visuelle.
- physiopathologie : Dégénérescence maculaire.
- traitement médicamenteux : Dégénérescence maculaire.
- Adulte d'âge moyen, Angiographie fluorescéinique, Femelle, Humains, Injections intravitréennes, Mâle, Méthode en double aveugle, Reprise du traitement, Sujet âgé, Sujet âgé de 80 ans ou plus, Tomographie par cohérence optique, Études de suivi, Études rétrospectives.
English descriptors
- KwdEn :
- Aged, Aged, 80 and over, Angiogenesis Inhibitors (administration & dosage), Double-Blind Method, Female, Fluorescein Angiography, Follow-Up Studies, Humans, Intravitreal Injections, Macular Degeneration (diagnosis), Macular Degeneration (drug therapy), Macular Degeneration (physiopathology), Male, Middle Aged, Ranibizumab (administration & dosage), Receptors, Vascular Endothelial Growth Factor (administration & dosage), Recombinant Fusion Proteins (administration & dosage), Retreatment, Retrospective Studies, Tomography, Optical Coherence, Vascular Endothelial Growth Factor A (antagonists & inhibitors), Visual Acuity (physiology).
- MESH :
- chemical , administration & dosage : Angiogenesis Inhibitors, Ranibizumab, Receptors, Vascular Endothelial Growth Factor, Recombinant Fusion Proteins.
- chemical , antagonists & inhibitors : Vascular Endothelial Growth Factor A.
- diagnosis : Macular Degeneration.
- drug therapy : Macular Degeneration.
- physiology : Visual Acuity.
- physiopathology : Macular Degeneration.
- Aged, Aged, 80 and over, Double-Blind Method, Female, Fluorescein Angiography, Follow-Up Studies, Humans, Intravitreal Injections, Male, Middle Aged, Retreatment, Retrospective Studies, Tomography, Optical Coherence.
Abstract
To analyze visual acuity (VA) outcomes before and after preplanned treatment regimen change in the VIEW studies at week 52 (W52).
DOI: 10.1016/j.ophtha.2015.08.014
PubMed: 26477840
Links toward previous steps (curation, corpus...)
- to stream PubMed, to step Corpus: 002665
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pubmed:26477840Le document en format XML
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<term>Adulte d'âge moyen</term>
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<term>Dégénérescence maculaire (diagnostic)</term>
<term>Dégénérescence maculaire (physiopathologie)</term>
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<term>Recombinant Fusion Proteins</term>
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<term>Récepteurs aux facteurs de croissance endothéliale vasculaire</term>
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<term>Aged, 80 and over</term>
<term>Double-Blind Method</term>
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<term>Middle Aged</term>
<term>Retreatment</term>
<term>Retrospective Studies</term>
<term>Tomography, Optical Coherence</term>
</keywords>
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<term>Angiographie fluorescéinique</term>
<term>Femelle</term>
<term>Humains</term>
<term>Injections intravitréennes</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Reprise du traitement</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
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<front><div type="abstract" xml:lang="en">To analyze visual acuity (VA) outcomes before and after preplanned treatment regimen change in the VIEW studies at week 52 (W52).</div>
</front>
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<Month>11</Month>
<Day>23</Day>
</DateCreated>
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<Title>Ophthalmology</Title>
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<ArticleTitle>Scheduled versus Pro Re Nata Dosing in the VIEW Trials.</ArticleTitle>
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</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.ophtha.2015.08.014</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">S0161-6420(15)00828-3</ELocationID>
<Abstract><AbstractText Label="PURPOSE" NlmCategory="OBJECTIVE">To analyze visual acuity (VA) outcomes before and after preplanned treatment regimen change in the VIEW studies at week 52 (W52).</AbstractText>
<AbstractText Label="DESIGN" NlmCategory="METHODS">Multiple post hoc analyses for retrospectively defined subgroups in 2 multicenter, multinational, double-masked trials.</AbstractText>
<AbstractText Label="PARTICIPANTS" NlmCategory="METHODS">Two thousand four hundred fifty-seven neovascular age-related macular degeneration (AMD) patients.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Patients were randomized to treatment with 0.5 mg ranibizumab given monthly, a 0.5-mg or 2-mg intravitreal aflibercept injection given monthly, or 2 mg intravitreal aflibercept given every other month, after 3 initial monthly doses, up to W52. From W52 through W96, patients received their original dosing assignment using a capped pro re nata (PRN) regimen, with defined retreatment criteria based on VA and morphologic signs of disease activity and mandatory dosing at least every 12 weeks.</AbstractText>
<AbstractText Label="MAIN OUTCOME MEASURES" NlmCategory="METHODS">Best-corrected VA (BCVA) and optical coherence tomography assessments were mandatory at all visits from baseline to W96. Outcomes were changes in BCVA and central retinal thickness. Outcomes were evaluated in all patients who completed 2 years of the VIEW studies using the last observation carried forward method for missing data at interim visits.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">After W52, approximately 20% of patients lost 5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or more across all treatment arms with PRN treatment. Patients who met the retreatment criterion of loss of 5 ETDRS letters or more in the first quarter of the PRN dosing phase did not recover; mean final VA loss across the 4 study arms was -4.4 to -5.8 letters. Outcomes of these patients up to W52 were indistinguishable from those of the overall population. There were no differences between groups in serious ocular adverse events or Anti-Platelet Trialists' Collaboration arterial thromboembolic events through W96.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">These analyses suggest that there are subgroups of patients for whom VA outcomes in the second year of the VIEW studies were less stable than in the first year and for whom W52 seems to be an important inflection point. Although alternate reasons specific to the nature of the underlying AMD cannot be fully excluded, the switch in treatment regimen at W52 is a plausible explanation.</AbstractText>
<CopyrightInformation>Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Richard</LastName>
<ForeName>Gisbert</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>Department of Ophthalmology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Electronic address: richard@uke.de.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Monés</LastName>
<ForeName>Jordi</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Institut de la Macula i de la Retina, Hospital Quiron Teknon, Barcelona, Spain, and Barcelona Macula Foundation, Barcelona, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Wolf</LastName>
<ForeName>Sebastian</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Department of Ophthalmology, University Hospital Bern, Inselspital, University of Bern, Bern, Switzerland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Korobelnik</LastName>
<ForeName>Jean François</ForeName>
<Initials>JF</Initials>
<AffiliationInfo><Affiliation>Service d'Ophtalmologie, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France; Institut de Santé Publique, d'Epidémiologie et de Développement, Université de Bordeaux, Bordeaux, France; Centre Epidemiologie-Biostatistique, Institut National de la Santé et de la Recherche Médicale, Bordeaux, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Guymer</LastName>
<ForeName>Robyn</ForeName>
<Initials>R</Initials>
<AffiliationInfo><Affiliation>Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, Melbourne, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Goldstein</LastName>
<ForeName>Michaella</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Tel Aviv Medical Center, Tel Aviv, Israel, and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Norenberg</LastName>
<ForeName>Christiane</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Bayer Pharma AG, Berlin, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Sandbrink</LastName>
<ForeName>Rupert</ForeName>
<Initials>R</Initials>
<AffiliationInfo><Affiliation>Bayer Pharma AG, Berlin, Germany; Department of Neurology, Heinrich-Heine University, Düsseldorf, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Zeitz</LastName>
<ForeName>Oliver</ForeName>
<Initials>O</Initials>
<AffiliationInfo><Affiliation>Department of Ophthalmology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Bayer Pharma AG, Berlin, Germany.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D003160">Comparative Study</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>21</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>United States</Country>
<MedlineTA>Ophthalmology</MedlineTA>
<NlmUniqueID>7802443</NlmUniqueID>
<ISSNLinking>0161-6420</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D020533">Angiogenesis Inhibitors</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D011993">Recombinant Fusion Proteins</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="C467484">VEGFA protein, human</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D042461">Vascular Endothelial Growth Factor A</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>15C2VL427D</RegistryNumber>
<NameOfSubstance UI="C533178">aflibercept</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>EC 2.7.10.1</RegistryNumber>
<NameOfSubstance UI="D040262">Receptors, Vascular Endothelial Growth Factor</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>ZL1R02VT79</RegistryNumber>
<NameOfSubstance UI="D000069579">Ranibizumab</NameOfSubstance>
</Chemical>
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<CitationSubset>IM</CitationSubset>
<MeshHeadingList><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D020533" MajorTopicYN="N">Angiogenesis Inhibitors</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005451" MajorTopicYN="N">Fluorescein Angiography</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005500" MajorTopicYN="N">Follow-Up Studies</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D058449" MajorTopicYN="N">Intravitreal Injections</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008268" MajorTopicYN="N">Macular Degeneration</DescriptorName>
<QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName>
<QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName>
<QualifierName UI="Q000503" MajorTopicYN="Y">physiopathology</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="D040262" MajorTopicYN="N">Receptors, Vascular Endothelial Growth Factor</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D011993" MajorTopicYN="N">Recombinant Fusion Proteins</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D019233" MajorTopicYN="N">Retreatment</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D012189" MajorTopicYN="N">Retrospective Studies</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D041623" MajorTopicYN="N">Tomography, Optical Coherence</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D042461" MajorTopicYN="N">Vascular Endothelial Growth Factor A</DescriptorName>
<QualifierName UI="Q000037" MajorTopicYN="N">antagonists & inhibitors</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D014792" MajorTopicYN="N">Visual Acuity</DescriptorName>
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</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2014</Year>
<Month>09</Month>
<Day>30</Day>
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<PubMedPubDate PubStatus="revised"><Year>2015</Year>
<Month>08</Month>
<Day>10</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2015</Year>
<Month>08</Month>
<Day>11</Day>
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<Month>10</Month>
<Day>20</Day>
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<PubMedPubDate PubStatus="medline"><Year>2016</Year>
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<ArticleId IdType="pii">S0161-6420(15)00828-3</ArticleId>
<ArticleId IdType="doi">10.1016/j.ophtha.2015.08.014</ArticleId>
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<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Espagne</li>
<li>France</li>
<li>Israël</li>
<li>Suisse</li>
</country>
<region><li>Aquitaine</li>
<li>Berlin</li>
<li>Canton de Berne</li>
<li>Catalogne</li>
<li>District de Düsseldorf</li>
<li>Hambourg</li>
<li>Nouvelle-Aquitaine</li>
<li>Rhénanie-du-Nord-Westphalie</li>
<li>Victoria (État)</li>
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<settlement><li>Barcelone</li>
<li>Berlin</li>
<li>Berne</li>
<li>Bordeaux</li>
<li>Düsseldorf</li>
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<li>Melbourne</li>
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<orgName><li>Université de Melbourne</li>
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<tree><country name="Allemagne"><region name="Hambourg"><name sortKey="Richard, Gisbert" sort="Richard, Gisbert" uniqKey="Richard G" first="Gisbert" last="Richard">Gisbert Richard</name>
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<name sortKey="Norenberg, Christiane" sort="Norenberg, Christiane" uniqKey="Norenberg C" first="Christiane" last="Norenberg">Christiane Norenberg</name>
<name sortKey="Sandbrink, Rupert" sort="Sandbrink, Rupert" uniqKey="Sandbrink R" first="Rupert" last="Sandbrink">Rupert Sandbrink</name>
<name sortKey="Zeitz, Oliver" sort="Zeitz, Oliver" uniqKey="Zeitz O" first="Oliver" last="Zeitz">Oliver Zeitz</name>
</country>
<country name="Espagne"><region name="Catalogne"><name sortKey="Mones, Jordi" sort="Mones, Jordi" uniqKey="Mones J" first="Jordi" last="Monés">Jordi Monés</name>
</region>
</country>
<country name="Suisse"><region name="Canton de Berne"><name sortKey="Wolf, Sebastian" sort="Wolf, Sebastian" uniqKey="Wolf S" first="Sebastian" last="Wolf">Sebastian Wolf</name>
</region>
</country>
<country name="France"><region name="Nouvelle-Aquitaine"><name sortKey="Korobelnik, Jean Francois" sort="Korobelnik, Jean Francois" uniqKey="Korobelnik J" first="Jean François" last="Korobelnik">Jean François Korobelnik</name>
</region>
</country>
<country name="Australie"><region name="Victoria (État)"><name sortKey="Guymer, Robyn" sort="Guymer, Robyn" uniqKey="Guymer R" first="Robyn" last="Guymer">Robyn Guymer</name>
</region>
</country>
<country name="Israël"><noRegion><name sortKey="Goldstein, Michaella" sort="Goldstein, Michaella" uniqKey="Goldstein M" first="Michaella" last="Goldstein">Michaella Goldstein</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>
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