Ranibizumab (Lucentis) in neovascular age-related macular degeneration: evidence from clinical trials
Identifieur interne : 000973 ( Istex/Checkpoint ); précédent : 000972; suivant : 000974Ranibizumab (Lucentis) in neovascular age-related macular degeneration: evidence from clinical trials
Auteurs : P. Mitchell [Australie] ; J-F Korobelnik [France] ; P. Lanzetta [Italie] ; F G Holz [Allemagne] ; C. Prünte [Autriche] ; U. Schmidt-Erfurth [Autriche] ; Y. Tano [Japon] ; S. Wolf [Suisse]Source :
- British Journal of Ophthalmology [ 0007-1161 ] ; 2010-01.
Descripteurs français
- Wicri :
- topic : Conseil et expertise.
English descriptors
- KwdEn :
- Active disease, Acuity, Additional treatment, Adverse events, Alcon, Appropriate intervals, Baseline, Choroidal, Choroidal neovascularisation, Choroidal neovascularization, Clinical practice, Clinical recommendation, Clinical trial evidence, Clinical trials, Coherence, Consultancy, Degeneration, Early treatment, Epithelial, Evidence level, Expert opinion, Fewer injections, Flexible strategy, Fluorescein angiography, Foveal centre, Guideline, Haemorrhage, Inclusion criteria, Interim data, Intravitreal, Intravitreal injections, Intravitreal ranibizumab, Ischaemic stroke, Leakage, Lesion, Lesion size, Lucentis, Macular, Macular degeneration, Maintenance phase, Monthly injections, Monthly monitoring, Monthly regimen, Monthly treatment, Myocardial infarction, Natural history, Neovascular, Neovascular agerelated macular degeneration, Neovascular macular degeneration, Neovascularisation, Neovascularization, Novartis, Novartis pharma, Occult, Ophthalmol, Ophthalmol review table, Ophthalmology, Optical coherence tomography, Pharma, Photodynamic, Photodynamic therapy, Pier, Pier studies, Pier study, Polypoidal choroidal vasculopathy, Randomised, Ranibizumab, Ranibizumab phase, Ranibizumab therapy, Ranibizumab treatment, Regimen, Retina, Retinal, Retinal angiomatous proliferation, Retinal pigment epithelial, Retinopathy study charts, Retreatment, Risk factors, Sailor cohort, Sham, Sham control, Snellen, Study arms, Study group, Subfoveal, Subgroup, Subgroup analysis, Subretinal, Systematic review, Third year, Tomography, Unknown cause, Verteporfin, Verteporfin photodynamic therapy, Visual acuity.
- Teeft :
- Active disease, Acuity, Additional treatment, Adverse events, Alcon, Appropriate intervals, Baseline, Choroidal, Choroidal neovascularisation, Choroidal neovascularization, Clinical practice, Clinical recommendation, Clinical trial evidence, Clinical trials, Coherence, Consultancy, Degeneration, Early treatment, Epithelial, Evidence level, Expert opinion, Fewer injections, Flexible strategy, Fluorescein angiography, Foveal centre, Guideline, Haemorrhage, Inclusion criteria, Interim data, Intravitreal, Intravitreal injections, Intravitreal ranibizumab, Ischaemic stroke, Leakage, Lesion, Lesion size, Lucentis, Macular, Macular degeneration, Maintenance phase, Monthly injections, Monthly monitoring, Monthly regimen, Monthly treatment, Myocardial infarction, Natural history, Neovascular, Neovascular agerelated macular degeneration, Neovascular macular degeneration, Neovascularisation, Neovascularization, Novartis, Novartis pharma, Occult, Ophthalmol, Ophthalmol review table, Ophthalmology, Optical coherence tomography, Pharma, Photodynamic, Photodynamic therapy, Pier, Pier studies, Pier study, Polypoidal choroidal vasculopathy, Randomised, Ranibizumab, Ranibizumab phase, Ranibizumab therapy, Ranibizumab treatment, Regimen, Retina, Retinal, Retinal angiomatous proliferation, Retinal pigment epithelial, Retinopathy study charts, Retreatment, Risk factors, Sailor cohort, Sham, Sham control, Snellen, Study arms, Study group, Subfoveal, Subgroup, Subgroup analysis, Subretinal, Systematic review, Third year, Tomography, Unknown cause, Verteporfin, Verteporfin photodynamic therapy, Visual acuity.
Abstract
Background: Neovascular age-related macular degeneration (AMD) has a poor prognosis if left untreated, frequently resulting in legal blindness. Ranibizumab is approved for treating neovascular AMD. However, further guidance is needed to assist ophthalmologists in clinical practice to optimise treatment outcomes. Methods: An international retina expert panel assessed evidence available from prospective, multicentre studies evaluating different ranibizumab treatment schedules (ANCHOR, MARINA, PIER, SAILOR, SUSTAIN and EXCITE) and a literature search to generate evidence-based and consensus recommendations for treatment indication and assessment, retreatment and monitoring. Results: Ranibizumab is indicated for choroidal neovascular lesions with active disease, the clinical parameters of which are outlined. Treatment initiation with three consecutive monthly injections, followed by continued monthly injections, has provided the best visual-acuity outcomes in pivotal clinical trials. If continued monthly injections are not feasible after initiation, a flexible strategy appears viable, with monthly monitoring of lesion activity recommended. Initiation regimens of fewer than three injections have not been assessed. Continuous careful monitoring with flexible retreatment may help avoid vision loss recurring. Standardised biomarkers need to be determined. Conclusion: Evidence-based guidelines will help to optimise treatment outcomes with ranibizumab in neovascular AMD.
Url:
DOI: 10.1136/bjo.2009.159160
Affiliations:
- Allemagne, Australie, Autriche, France, Italie, Japon, Suisse
- Aquitaine, Canton de Berne, District de Cologne, Nouvelle-Aquitaine, Nouvelle-Galles du Sud, Rhénanie-du-Nord-Westphalie, Vienne (Autriche)
- Berne, Bonn, Bordeaux, Sydney, Vienne (Autriche)
- Université de Berne, Université de Sydney
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Mitchell</name><affiliation wicri:level="4"><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Ophthalmology, University of Sydney, Sydney</wicri:regionArea><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region><settlement type="city">Sydney</settlement></placeName><orgName type="university">Université de Sydney</orgName></affiliation></author><author><name sortKey="Korobelnik, J F" sort="Korobelnik, J F" uniqKey="Korobelnik J" first="J-F" last="Korobelnik">J-F Korobelnik</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Department of Ophthalmology, Centre Hospitalier Universitaire de Bordeaux, Bordeaux</wicri:regionArea><placeName><region type="region">Nouvelle-Aquitaine</region><region type="old region">Aquitaine</region><settlement type="city">Bordeaux</settlement></placeName></affiliation></author><author><name sortKey="Lanzetta, P" sort="Lanzetta, P" uniqKey="Lanzetta P" first="P" last="Lanzetta">P. Lanzetta</name><affiliation wicri:level="1"><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Ophthalmology, University of Udine, Udine</wicri:regionArea><wicri:noRegion>Udine</wicri:noRegion></affiliation></author><author><name sortKey="Holz, F G" sort="Holz, F G" uniqKey="Holz F" first="F G" last="Holz">F G Holz</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Ophthalmology, University of Bonn, Bonn</wicri:regionArea><placeName><region type="land" nuts="1">Rhénanie-du-Nord-Westphalie</region><region type="district" nuts="2">District de Cologne</region><settlement type="city">Bonn</settlement></placeName></affiliation></author><author><name sortKey="Prunte, C" sort="Prunte, C" uniqKey="Prunte C" first="C" last="Prünte">C. Prünte</name><affiliation wicri:level="3"><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna</wicri:regionArea><placeName><settlement type="city">Vienne (Autriche)</settlement><region nuts="2" type="province">Vienne (Autriche)</region></placeName></affiliation></author><author><name sortKey="Schmidt Erfurth, U" sort="Schmidt Erfurth, U" uniqKey="Schmidt Erfurth U" first="U" last="Schmidt-Erfurth">U. Schmidt-Erfurth</name><affiliation wicri:level="3"><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna</wicri:regionArea><placeName><settlement type="city">Vienne (Autriche)</settlement><region nuts="2" type="province">Vienne (Autriche)</region></placeName></affiliation></author><author><name sortKey="Tano, Y" sort="Tano, Y" uniqKey="Tano Y" first="Y" last="Tano">Y. Tano</name><affiliation wicri:level="1"><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Ophthalmology, Osaka University Medical School, Osaka</wicri:regionArea><wicri:noRegion>Osaka</wicri:noRegion></affiliation></author><author><name sortKey="Wolf, S" sort="Wolf, S" uniqKey="Wolf S" first="S" last="Wolf">S. Wolf</name><affiliation wicri:level="4"><country xml:lang="fr">Suisse</country><wicri:regionArea>Department of Ophthalmology, Inselspital, University of Bern, Bern</wicri:regionArea><placeName><settlement type="city">Berne</settlement><region type="région" nuts="3">Canton de Berne</region><settlement type="city">Berne</settlement></placeName><orgName type="university">Université de Berne</orgName></affiliation></author></analytic><monogr></monogr><series><title level="j">British Journal of Ophthalmology</title><title level="j" type="abbrev">Br J Ophthalmol</title><idno type="ISSN">0007-1161</idno><idno type="eISSN">1468-2079</idno><imprint><publisher>BMJ Publishing Group Ltd.</publisher><pubPlace>BMA House, Tavistock Square, London, WC1H 9JR</pubPlace><date type="published" when="2010-01">2010-01</date><biblScope unit="volume">94</biblScope><biblScope unit="issue">1</biblScope><biblScope unit="page" from="2">2</biblScope></imprint><idno type="ISSN">0007-1161</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0007-1161</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Active disease</term><term>Acuity</term><term>Additional treatment</term><term>Adverse events</term><term>Alcon</term><term>Appropriate intervals</term><term>Baseline</term><term>Choroidal</term><term>Choroidal neovascularisation</term><term>Choroidal neovascularization</term><term>Clinical practice</term><term>Clinical recommendation</term><term>Clinical trial evidence</term><term>Clinical trials</term><term>Coherence</term><term>Consultancy</term><term>Degeneration</term><term>Early treatment</term><term>Epithelial</term><term>Evidence level</term><term>Expert opinion</term><term>Fewer injections</term><term>Flexible strategy</term><term>Fluorescein angiography</term><term>Foveal centre</term><term>Guideline</term><term>Haemorrhage</term><term>Inclusion criteria</term><term>Interim data</term><term>Intravitreal</term><term>Intravitreal injections</term><term>Intravitreal ranibizumab</term><term>Ischaemic stroke</term><term>Leakage</term><term>Lesion</term><term>Lesion size</term><term>Lucentis</term><term>Macular</term><term>Macular degeneration</term><term>Maintenance phase</term><term>Monthly injections</term><term>Monthly monitoring</term><term>Monthly regimen</term><term>Monthly treatment</term><term>Myocardial infarction</term><term>Natural history</term><term>Neovascular</term><term>Neovascular agerelated macular degeneration</term><term>Neovascular macular degeneration</term><term>Neovascularisation</term><term>Neovascularization</term><term>Novartis</term><term>Novartis pharma</term><term>Occult</term><term>Ophthalmol</term><term>Ophthalmol review table</term><term>Ophthalmology</term><term>Optical coherence tomography</term><term>Pharma</term><term>Photodynamic</term><term>Photodynamic therapy</term><term>Pier</term><term>Pier studies</term><term>Pier study</term><term>Polypoidal choroidal vasculopathy</term><term>Randomised</term><term>Ranibizumab</term><term>Ranibizumab phase</term><term>Ranibizumab therapy</term><term>Ranibizumab treatment</term><term>Regimen</term><term>Retina</term><term>Retinal</term><term>Retinal angiomatous proliferation</term><term>Retinal pigment epithelial</term><term>Retinopathy study charts</term><term>Retreatment</term><term>Risk factors</term><term>Sailor cohort</term><term>Sham</term><term>Sham control</term><term>Snellen</term><term>Study arms</term><term>Study group</term><term>Subfoveal</term><term>Subgroup</term><term>Subgroup analysis</term><term>Subretinal</term><term>Systematic review</term><term>Third year</term><term>Tomography</term><term>Unknown cause</term><term>Verteporfin</term><term>Verteporfin photodynamic therapy</term><term>Visual acuity</term></keywords><keywords scheme="Teeft" xml:lang="en"><term>Active disease</term><term>Acuity</term><term>Additional treatment</term><term>Adverse events</term><term>Alcon</term><term>Appropriate intervals</term><term>Baseline</term><term>Choroidal</term><term>Choroidal neovascularisation</term><term>Choroidal neovascularization</term><term>Clinical practice</term><term>Clinical recommendation</term><term>Clinical trial evidence</term><term>Clinical trials</term><term>Coherence</term><term>Consultancy</term><term>Degeneration</term><term>Early treatment</term><term>Epithelial</term><term>Evidence level</term><term>Expert opinion</term><term>Fewer injections</term><term>Flexible strategy</term><term>Fluorescein angiography</term><term>Foveal centre</term><term>Guideline</term><term>Haemorrhage</term><term>Inclusion criteria</term><term>Interim data</term><term>Intravitreal</term><term>Intravitreal injections</term><term>Intravitreal ranibizumab</term><term>Ischaemic stroke</term><term>Leakage</term><term>Lesion</term><term>Lesion size</term><term>Lucentis</term><term>Macular</term><term>Macular degeneration</term><term>Maintenance phase</term><term>Monthly injections</term><term>Monthly monitoring</term><term>Monthly regimen</term><term>Monthly treatment</term><term>Myocardial infarction</term><term>Natural history</term><term>Neovascular</term><term>Neovascular agerelated macular degeneration</term><term>Neovascular macular degeneration</term><term>Neovascularisation</term><term>Neovascularization</term><term>Novartis</term><term>Novartis pharma</term><term>Occult</term><term>Ophthalmol</term><term>Ophthalmol review table</term><term>Ophthalmology</term><term>Optical coherence tomography</term><term>Pharma</term><term>Photodynamic</term><term>Photodynamic therapy</term><term>Pier</term><term>Pier studies</term><term>Pier study</term><term>Polypoidal choroidal vasculopathy</term><term>Randomised</term><term>Ranibizumab</term><term>Ranibizumab phase</term><term>Ranibizumab therapy</term><term>Ranibizumab treatment</term><term>Regimen</term><term>Retina</term><term>Retinal</term><term>Retinal angiomatous proliferation</term><term>Retinal pigment epithelial</term><term>Retinopathy study charts</term><term>Retreatment</term><term>Risk factors</term><term>Sailor cohort</term><term>Sham</term><term>Sham control</term><term>Snellen</term><term>Study arms</term><term>Study group</term><term>Subfoveal</term><term>Subgroup</term><term>Subgroup analysis</term><term>Subretinal</term><term>Systematic review</term><term>Third year</term><term>Tomography</term><term>Unknown cause</term><term>Verteporfin</term><term>Verteporfin photodynamic therapy</term><term>Visual acuity</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Conseil et expertise</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Background: Neovascular age-related macular degeneration (AMD) has a poor prognosis if left untreated, frequently resulting in legal blindness. Ranibizumab is approved for treating neovascular AMD. However, further guidance is needed to assist ophthalmologists in clinical practice to optimise treatment outcomes. Methods: An international retina expert panel assessed evidence available from prospective, multicentre studies evaluating different ranibizumab treatment schedules (ANCHOR, MARINA, PIER, SAILOR, SUSTAIN and EXCITE) and a literature search to generate evidence-based and consensus recommendations for treatment indication and assessment, retreatment and monitoring. Results: Ranibizumab is indicated for choroidal neovascular lesions with active disease, the clinical parameters of which are outlined. Treatment initiation with three consecutive monthly injections, followed by continued monthly injections, has provided the best visual-acuity outcomes in pivotal clinical trials. If continued monthly injections are not feasible after initiation, a flexible strategy appears viable, with monthly monitoring of lesion activity recommended. Initiation regimens of fewer than three injections have not been assessed. Continuous careful monitoring with flexible retreatment may help avoid vision loss recurring. Standardised biomarkers need to be determined. Conclusion: Evidence-based guidelines will help to optimise treatment outcomes with ranibizumab in neovascular AMD.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Autriche</li><li>France</li><li>Italie</li><li>Japon</li><li>Suisse</li></country><region><li>Aquitaine</li><li>Canton de Berne</li><li>District de Cologne</li><li>Nouvelle-Aquitaine</li><li>Nouvelle-Galles du Sud</li><li>Rhénanie-du-Nord-Westphalie</li><li>Vienne (Autriche)</li></region><settlement><li>Berne</li><li>Bonn</li><li>Bordeaux</li><li>Sydney</li><li>Vienne (Autriche)</li></settlement><orgName><li>Université de Berne</li><li>Université de Sydney</li></orgName></list><tree><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Mitchell, P" sort="Mitchell, P" uniqKey="Mitchell P" first="P" last="Mitchell">P. Mitchell</name></region></country><country name="France"><region name="Nouvelle-Aquitaine"><name sortKey="Korobelnik, J F" sort="Korobelnik, J F" uniqKey="Korobelnik J" first="J-F" last="Korobelnik">J-F Korobelnik</name></region></country><country name="Italie"><noRegion><name sortKey="Lanzetta, P" sort="Lanzetta, P" uniqKey="Lanzetta P" first="P" last="Lanzetta">P. Lanzetta</name></noRegion></country><country name="Allemagne"><region name="Rhénanie-du-Nord-Westphalie"><name sortKey="Holz, F G" sort="Holz, F G" uniqKey="Holz F" first="F G" last="Holz">F G Holz</name></region></country><country name="Autriche"><region name="Vienne (Autriche)"><name sortKey="Prunte, C" sort="Prunte, C" uniqKey="Prunte C" first="C" last="Prünte">C. Prünte</name></region><name sortKey="Schmidt Erfurth, U" sort="Schmidt Erfurth, U" uniqKey="Schmidt Erfurth U" first="U" last="Schmidt-Erfurth">U. Schmidt-Erfurth</name></country><country name="Japon"><noRegion><name sortKey="Tano, Y" sort="Tano, Y" uniqKey="Tano Y" first="Y" last="Tano">Y. Tano</name></noRegion></country><country name="Suisse"><region name="Canton de Berne"><name sortKey="Wolf, S" sort="Wolf, S" uniqKey="Wolf S" first="S" last="Wolf">S. Wolf</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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