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Scheduled versus Pro Re Nata Dosing in the VIEW Trials.

Identifieur interne : 002C36 ( Ncbi/Merge ); précédent : 002C35; suivant : 002C37

Scheduled 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 :

RBID : pubmed:26477840

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English descriptors

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

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pubmed:26477840

Le document en format XML

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<term>Double-Blind Method</term>
<term>Female</term>
<term>Fluorescein Angiography</term>
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<term>Intravitreal Injections</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>
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<DateCreated>
<Year>2015</Year>
<Month>11</Month>
<Day>23</Day>
</DateCreated>
<DateCompleted>
<Year>2016</Year>
<Month>03</Month>
<Day>17</Day>
</DateCompleted>
<DateRevised>
<Year>2015</Year>
<Month>11</Month>
<Day>23</Day>
</DateRevised>
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<Journal>
<ISSN IssnType="Electronic">1549-4713</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>122</Volume>
<Issue>12</Issue>
<PubDate>
<Year>2015</Year>
<Month>Dec</Month>
</PubDate>
</JournalIssue>
<Title>Ophthalmology</Title>
<ISOAbbreviation>Ophthalmology</ISOAbbreviation>
</Journal>
<ArticleTitle>Scheduled versus Pro Re Nata Dosing in the VIEW Trials.</ArticleTitle>
<Pagination>
<MedlinePgn>2497-503</MedlinePgn>
</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>
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<LastName>Richard</LastName>
<ForeName>Gisbert</ForeName>
<Initials>G</Initials>
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<Affiliation>Department of Ophthalmology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Electronic address: richard@uke.de.</Affiliation>
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<Author ValidYN="Y">
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