Randomized Trial Evaluating Ranibizumab Plus Prompt or Deferred Laser or Triamcinolone Plus Prompt Laser for Diabetic Macular Edema
Identifieur interne : 003A79 ( Ncbi/Merge ); précédent : 003A78; suivant : 003A80Randomized Trial Evaluating Ranibizumab Plus Prompt or Deferred Laser or Triamcinolone Plus Prompt Laser for Diabetic Macular Edema
Auteurs : Michael J. Elman ; Lloyd Paul Aiello ; Roy W. Beck ; Neil M. Bressler ; Susan B. Bressler ; Allison R. Edwards ; Frederick L. Ferris ; Scott M. Friedman ; Adam R. Glassman ; Kellee M. Miller ; Ingrid U. Scott ; Cynthia R. Stockdale ; Jennifer K. SunSource :
- Ophthalmology [ 0161-6420 ] ; 2010.
Abstract
Evaluate intravitreal 0.5 mg ranibizumab or 4 mg triamcinolone combined with focal/grid laser compared with focal/grid laser alone for treatment of diabetic macular edema (DME).
Multicenter, randomized clinical trial.
A total of 854 study eyes of 691 participants with visual acuity (approximate Snellen equivalent) of 20/32 to 20/320 and DME involving the fovea.
Eyes were randomized to sham injection + prompt laser (n=293), 0.5 mg ranibizumab + prompt laser (n=187), 0.5 mg ranibizumab + deferred (≥24 weeks) laser (n=188), or 4 mg triamcinolone + prompt laser (n=186). Retreatment followed an algorithm facilitated by a web-based, real-time data-entry system.
Best-corrected visual acuity and safety at 1 year.
The 1-year mean change (±standard deviation) in the visual acuity letter score from baseline was significantly greater in the ranibizumab + prompt laser group (+9±11,
Intravitreal ranibizumab with prompt or deferred laser is more effective through at least 1 year compared with prompt laser alone for the treatment of DME involving the central macula. Ranibizumab as applied in this study, although uncommonly associated with endophthalmitis, should be considered for patients with DME and characteristics similar to those in this clinical trial. In pseudophakic eyes, intravitreal triamcinolone + prompt laser seems more effective than laser alone but frequently increases the risk of intraocular pressure elevation.
Url:
DOI: 10.1016/j.ophtha.2010.02.031
PubMed: 20427088
PubMed Central: 2937272
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Randomized Trial Evaluating Ranibizumab Plus Prompt or Deferred Laser or Triamcinolone Plus Prompt Laser for Diabetic Macular Edema</title><author><name sortKey="Elman, Michael J" sort="Elman, Michael J" uniqKey="Elman M" first="Michael J." last="Elman">Michael J. Elman</name></author><author><name sortKey="Aiello, Lloyd Paul" sort="Aiello, Lloyd Paul" uniqKey="Aiello L" first="Lloyd Paul" last="Aiello">Lloyd Paul Aiello</name></author><author><name sortKey="Beck, Roy W" sort="Beck, Roy W" uniqKey="Beck R" first="Roy W." last="Beck">Roy W. Beck</name></author><author><name sortKey="Bressler, Neil M" sort="Bressler, Neil M" uniqKey="Bressler N" first="Neil M." last="Bressler">Neil M. Bressler</name></author><author><name sortKey="Bressler, Susan B" sort="Bressler, Susan B" uniqKey="Bressler S" first="Susan B." last="Bressler">Susan B. Bressler</name></author><author><name sortKey="Edwards, Allison R" sort="Edwards, Allison R" uniqKey="Edwards A" first="Allison R." last="Edwards">Allison R. Edwards</name></author><author><name sortKey="Ferris, Frederick L" sort="Ferris, Frederick L" uniqKey="Ferris F" first="Frederick L." last="Ferris">Frederick L. Ferris</name></author><author><name sortKey="Friedman, Scott M" sort="Friedman, Scott M" uniqKey="Friedman S" first="Scott M." last="Friedman">Scott M. Friedman</name></author><author><name sortKey="Glassman, Adam R" sort="Glassman, Adam R" uniqKey="Glassman A" first="Adam R." last="Glassman">Adam R. Glassman</name></author><author><name sortKey="Miller, Kellee M" sort="Miller, Kellee M" uniqKey="Miller K" first="Kellee M." last="Miller">Kellee M. Miller</name></author><author><name sortKey="Scott, Ingrid U" sort="Scott, Ingrid U" uniqKey="Scott I" first="Ingrid U." last="Scott">Ingrid U. Scott</name></author><author><name sortKey="Stockdale, Cynthia R" sort="Stockdale, Cynthia R" uniqKey="Stockdale C" first="Cynthia R." last="Stockdale">Cynthia R. Stockdale</name></author><author><name sortKey="Sun, Jennifer K" sort="Sun, Jennifer K" uniqKey="Sun J" first="Jennifer K." last="Sun">Jennifer K. Sun</name></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">20427088</idno><idno type="pmc">2937272</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2937272</idno><idno type="RBID">PMC:2937272</idno><idno type="doi">10.1016/j.ophtha.2010.02.031</idno><date when="2010">2010</date><idno type="wicri:Area/Pmc/Corpus">002858</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">002858</idno><idno type="wicri:Area/Pmc/Curation">002857</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">002857</idno><idno type="wicri:Area/Pmc/Checkpoint">003254</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">003254</idno><idno type="wicri:Area/Ncbi/Merge">003A79</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Randomized Trial Evaluating Ranibizumab Plus Prompt or Deferred Laser or Triamcinolone Plus Prompt Laser for Diabetic Macular Edema</title><author><name sortKey="Elman, Michael J" sort="Elman, Michael J" uniqKey="Elman M" first="Michael J." last="Elman">Michael J. Elman</name></author><author><name sortKey="Aiello, Lloyd Paul" sort="Aiello, Lloyd Paul" uniqKey="Aiello L" first="Lloyd Paul" last="Aiello">Lloyd Paul Aiello</name></author><author><name sortKey="Beck, Roy W" sort="Beck, Roy W" uniqKey="Beck R" first="Roy W." last="Beck">Roy W. Beck</name></author><author><name sortKey="Bressler, Neil M" sort="Bressler, Neil M" uniqKey="Bressler N" first="Neil M." last="Bressler">Neil M. Bressler</name></author><author><name sortKey="Bressler, Susan B" sort="Bressler, Susan B" uniqKey="Bressler S" first="Susan B." last="Bressler">Susan B. Bressler</name></author><author><name sortKey="Edwards, Allison R" sort="Edwards, Allison R" uniqKey="Edwards A" first="Allison R." last="Edwards">Allison R. Edwards</name></author><author><name sortKey="Ferris, Frederick L" sort="Ferris, Frederick L" uniqKey="Ferris F" first="Frederick L." last="Ferris">Frederick L. Ferris</name></author><author><name sortKey="Friedman, Scott M" sort="Friedman, Scott M" uniqKey="Friedman S" first="Scott M." last="Friedman">Scott M. Friedman</name></author><author><name sortKey="Glassman, Adam R" sort="Glassman, Adam R" uniqKey="Glassman A" first="Adam R." last="Glassman">Adam R. Glassman</name></author><author><name sortKey="Miller, Kellee M" sort="Miller, Kellee M" uniqKey="Miller K" first="Kellee M." last="Miller">Kellee M. Miller</name></author><author><name sortKey="Scott, Ingrid U" sort="Scott, Ingrid U" uniqKey="Scott I" first="Ingrid U." last="Scott">Ingrid U. Scott</name></author><author><name sortKey="Stockdale, Cynthia R" sort="Stockdale, Cynthia R" uniqKey="Stockdale C" first="Cynthia R." last="Stockdale">Cynthia R. Stockdale</name></author><author><name sortKey="Sun, Jennifer K" sort="Sun, Jennifer K" uniqKey="Sun J" first="Jennifer K." last="Sun">Jennifer K. Sun</name></author></analytic><series><title level="j">Ophthalmology</title><idno type="ISSN">0161-6420</idno><idno type="eISSN">1549-4713</idno><imprint><date when="2010">2010</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>Objective</title><p id="P1">Evaluate intravitreal 0.5 mg ranibizumab or 4 mg triamcinolone combined with focal/grid laser compared with focal/grid laser alone for treatment of diabetic macular edema (DME).</p></sec><sec id="S2"><title>Design</title><p id="P2">Multicenter, randomized clinical trial.</p></sec><sec id="S3"><title>Participants</title><p id="P3">A total of 854 study eyes of 691 participants with visual acuity (approximate Snellen equivalent) of 20/32 to 20/320 and DME involving the fovea.</p></sec><sec sec-type="methods" id="S4"><title>Methods</title><p id="P4">Eyes were randomized to sham injection + prompt laser (n=293), 0.5 mg ranibizumab + prompt laser (n=187), 0.5 mg ranibizumab + deferred (≥24 weeks) laser (n=188), or 4 mg triamcinolone + prompt laser (n=186). Retreatment followed an algorithm facilitated by a web-based, real-time data-entry system.</p></sec><sec id="S5"><title>Main Outcome Measures</title><p id="P5">Best-corrected visual acuity and safety at 1 year.</p></sec><sec id="S6"><title>Results</title><p id="P6">The 1-year mean change (±standard deviation) in the visual acuity letter score from baseline was significantly greater in the ranibizumab + prompt laser group (+9±11, <italic>P</italic><0.001) and ranibizumab + deferred laser group (+9±12, <italic>P</italic><0.001) but not in the triamcinolone + prompt laser group (+4±13, <italic>P</italic>=0.31) compared with the sham + prompt laser group (+3±13). Reduction in mean central subfield thickness in the triamcinolone + prompt laser group was similar to both ranibizumab groups and greater than in the sham + prompt laser group. In the subset of pseudophakic eyes at baseline (n=273), visual acuity improvement in the triamcinolone + prompt laser group appeared comparable to that in the ranibizumab groups. No systemic events attributable to study treatment were apparent. Three eyes (0.8%) had injection-related endophthalmitis in the ranibizumab groups, whereas elevated intraocular pressure and cataract surgery were more frequent in the triamcinolone + prompt laser group. Two-year visual acuity outcomes were similar to 1-year outcomes.</p></sec><sec id="S7"><title>Conclusions</title><p id="P7">Intravitreal ranibizumab with prompt or deferred laser is more effective through at least 1 year compared with prompt laser alone for the treatment of DME involving the central macula. Ranibizumab as applied in this study, although uncommonly associated with endophthalmitis, should be considered for patients with DME and characteristics similar to those in this clinical trial. In pseudophakic eyes, intravitreal triamcinolone + prompt laser seems more effective than laser alone but frequently increases the risk of intraocular pressure elevation.</p></sec></div></front></TEI><pmc article-type="research-article" xml:lang="EN"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">7802443</journal-id><journal-id journal-id-type="pubmed-jr-id">6266</journal-id><journal-id journal-id-type="nlm-ta">Ophthalmology</journal-id><journal-title>Ophthalmology</journal-title><issn pub-type="ppub">0161-6420</issn><issn pub-type="epub">1549-4713</issn></journal-meta><article-meta><article-id pub-id-type="pmid">20427088</article-id><article-id pub-id-type="pmc">2937272</article-id><article-id pub-id-type="doi">10.1016/j.ophtha.2010.02.031</article-id><article-id pub-id-type="manuscript">NIHMS185456</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Randomized Trial Evaluating Ranibizumab Plus Prompt or Deferred Laser or Triamcinolone Plus Prompt Laser for Diabetic Macular Edema</article-title></title-group><contrib-group><contrib contrib-type="author"><collab>The Diabetic Retinopathy Clinical Research Network</collab><xref rid="FN2" ref-type="author-notes">*</xref></contrib><contrib contrib-type="author"><name><surname>Elman</surname><given-names>Michael J.</given-names></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Aiello</surname><given-names>Lloyd Paul</given-names></name><degrees>MD, PhD</degrees></contrib><contrib contrib-type="author"><name><surname>Beck</surname><given-names>Roy W.</given-names></name><degrees>MD, PhD</degrees></contrib><contrib contrib-type="author"><name><surname>Bressler</surname><given-names>Neil M.</given-names></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Bressler</surname><given-names>Susan B.</given-names></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Edwards</surname><given-names>Allison R.</given-names></name><degrees>MS</degrees></contrib><contrib contrib-type="author"><name><surname>Ferris</surname><given-names>Frederick L.</given-names><suffix>III</suffix></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Friedman</surname><given-names>Scott M.</given-names></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Glassman</surname><given-names>Adam R.</given-names></name><degrees>MS</degrees></contrib><contrib contrib-type="author"><name><surname>Miller</surname><given-names>Kellee M.</given-names></name><degrees>MPH</degrees></contrib><contrib contrib-type="author"><name><surname>Scott</surname><given-names>Ingrid U.</given-names></name><degrees>MD, MPH</degrees></contrib><contrib contrib-type="author"><name><surname>Stockdale</surname><given-names>Cynthia R.</given-names></name><degrees>MSPH</degrees></contrib><contrib contrib-type="author"><name><surname>Sun</surname><given-names>Jennifer K.</given-names></name><degrees>MD, MPH</degrees></contrib></contrib-group><author-notes><corresp id="FN1">Correspondence: Protocol I Correspondence, Jaeb Center for Health Research, 15310 Amberly Drive, Suite 350, Tampa, FL 33647. <email>drcrstat4@jaeb.org</email></corresp><fn id="FN2" fn-type="other"><label>*</label><p>The members of the DRCR Network who participated in this protocol are listed in Appendix 5.</p></fn></author-notes><pub-date pub-type="nihms-submitted"><day>24</day><month>6</month><year>2010</year></pub-date><pub-date pub-type="epub"><day>28</day><month>4</month><year>2010</year></pub-date><pub-date pub-type="ppub"><month>6</month><year>2010</year></pub-date><pub-date pub-type="pmc-release"><day>1</day><month>6</month><year>2011</year></pub-date><volume>117</volume><issue>6</issue><fpage>1064</fpage><lpage>1077.e35</lpage><permissions><copyright-statement>© 2010 by the American Academy of Ophthalmology.</copyright-statement><copyright-year>2010</copyright-year></permissions><related-article journal-id-type="nlm-ta" journal-id="Ophthalmology" related-article-type="commentary" page="1059" id="N0x7eb6240N0x89bafd0" xlink:href="20522333" ext-link-type="pubmed" vol="117"></related-article><abstract><sec id="S1"><title>Objective</title><p id="P1">Evaluate intravitreal 0.5 mg ranibizumab or 4 mg triamcinolone combined with focal/grid laser compared with focal/grid laser alone for treatment of diabetic macular edema (DME).</p></sec><sec id="S2"><title>Design</title><p id="P2">Multicenter, randomized clinical trial.</p></sec><sec id="S3"><title>Participants</title><p id="P3">A total of 854 study eyes of 691 participants with visual acuity (approximate Snellen equivalent) of 20/32 to 20/320 and DME involving the fovea.</p></sec><sec sec-type="methods" id="S4"><title>Methods</title><p id="P4">Eyes were randomized to sham injection + prompt laser (n=293), 0.5 mg ranibizumab + prompt laser (n=187), 0.5 mg ranibizumab + deferred (≥24 weeks) laser (n=188), or 4 mg triamcinolone + prompt laser (n=186). Retreatment followed an algorithm facilitated by a web-based, real-time data-entry system.</p></sec><sec id="S5"><title>Main Outcome Measures</title><p id="P5">Best-corrected visual acuity and safety at 1 year.</p></sec><sec id="S6"><title>Results</title><p id="P6">The 1-year mean change (±standard deviation) in the visual acuity letter score from baseline was significantly greater in the ranibizumab + prompt laser group (+9±11, <italic>P</italic><0.001) and ranibizumab + deferred laser group (+9±12, <italic>P</italic><0.001) but not in the triamcinolone + prompt laser group (+4±13, <italic>P</italic>=0.31) compared with the sham + prompt laser group (+3±13). Reduction in mean central subfield thickness in the triamcinolone + prompt laser group was similar to both ranibizumab groups and greater than in the sham + prompt laser group. In the subset of pseudophakic eyes at baseline (n=273), visual acuity improvement in the triamcinolone + prompt laser group appeared comparable to that in the ranibizumab groups. No systemic events attributable to study treatment were apparent. Three eyes (0.8%) had injection-related endophthalmitis in the ranibizumab groups, whereas elevated intraocular pressure and cataract surgery were more frequent in the triamcinolone + prompt laser group. Two-year visual acuity outcomes were similar to 1-year outcomes.</p></sec><sec id="S7"><title>Conclusions</title><p id="P7">Intravitreal ranibizumab with prompt or deferred laser is more effective through at least 1 year compared with prompt laser alone for the treatment of DME involving the central macula. Ranibizumab as applied in this study, although uncommonly associated with endophthalmitis, should be considered for patients with DME and characteristics similar to those in this clinical trial. In pseudophakic eyes, intravitreal triamcinolone + prompt laser seems more effective than laser alone but frequently increases the risk of intraocular pressure elevation.</p></sec></abstract><contract-num rid="EY1">U10 EY018817-01
||EY</contract-num><contract-num rid="EY1">U10 EY014231-07
||EY</contract-num><contract-num rid="EY1">U10 EY014229-07
||EY</contract-num><contract-sponsor id="EY1">National Eye Institute : NEI</contract-sponsor></article-meta></front></pmc><affiliations><list></list><tree><noCountry><name sortKey="Aiello, Lloyd Paul" sort="Aiello, Lloyd Paul" uniqKey="Aiello L" first="Lloyd Paul" last="Aiello">Lloyd Paul Aiello</name><name sortKey="Beck, Roy W" sort="Beck, Roy W" uniqKey="Beck R" first="Roy W." last="Beck">Roy W. Beck</name><name sortKey="Bressler, Neil M" sort="Bressler, Neil M" uniqKey="Bressler N" first="Neil M." last="Bressler">Neil M. Bressler</name><name sortKey="Bressler, Susan B" sort="Bressler, Susan B" uniqKey="Bressler S" first="Susan B." last="Bressler">Susan B. Bressler</name><name sortKey="Edwards, Allison R" sort="Edwards, Allison R" uniqKey="Edwards A" first="Allison R." last="Edwards">Allison R. Edwards</name><name sortKey="Elman, Michael J" sort="Elman, Michael J" uniqKey="Elman M" first="Michael J." last="Elman">Michael J. Elman</name><name sortKey="Ferris, Frederick L" sort="Ferris, Frederick L" uniqKey="Ferris F" first="Frederick L." last="Ferris">Frederick L. Ferris</name><name sortKey="Friedman, Scott M" sort="Friedman, Scott M" uniqKey="Friedman S" first="Scott M." last="Friedman">Scott M. Friedman</name><name sortKey="Glassman, Adam R" sort="Glassman, Adam R" uniqKey="Glassman A" first="Adam R." last="Glassman">Adam R. Glassman</name><name sortKey="Miller, Kellee M" sort="Miller, Kellee M" uniqKey="Miller K" first="Kellee M." last="Miller">Kellee M. Miller</name><name sortKey="Scott, Ingrid U" sort="Scott, Ingrid U" uniqKey="Scott I" first="Ingrid U." last="Scott">Ingrid U. Scott</name><name sortKey="Stockdale, Cynthia R" sort="Stockdale, Cynthia R" uniqKey="Stockdale C" first="Cynthia R." last="Stockdale">Cynthia R. Stockdale</name><name sortKey="Sun, Jennifer K" sort="Sun, Jennifer K" uniqKey="Sun J" first="Jennifer K." last="Sun">Jennifer K. Sun</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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