Impact of intravitreal aflibercept dosing regimens in treatment-naïve patients with neovascular age-related macular degeneration in routine clinical practice in France: results from the RAINBOW study
ObjectiveTo evaluate 12-month outcomes in treatment-naïve patients with neovascular (wet) age-related macular degeneration (AMD) stratified by intravitreal aflibercept (IVT-AFL) regimen.Methods and analysisPatients included in the 12-month interim analysis of Real life of intravitreal Aflibercept In...
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| Vydáno v: | BMJ open ophthalmology Ročník 5; číslo 1; s. e000377 |
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BMJ Publishing Group Ltd
06.04.2020
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| ISSN: | 2397-3269, 2397-3269 |
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| Abstract | ObjectiveTo evaluate 12-month outcomes in treatment-naïve patients with neovascular (wet) age-related macular degeneration (AMD) stratified by intravitreal aflibercept (IVT-AFL) regimen.Methods and analysisPatients included in the 12-month interim analysis of Real life of intravitreal Aflibercept In FraNce: oBservatiOnal Study in Wet AMD (RAINBOW), a 4-year, ongoing observational study conducted in France, were stratified by IVT-AFL dosing regimen. Safety (n=593) and effectiveness (n=428) data were analysed. Regimens included a regular cohort (three initial monthly IVT-AFL injections and ≥6 injections) and irregular cohorts (<6 injections) with and without three initial monthly injections. The main outcome measure was mean gain in best-corrected visual acuity (BCVA) at 12 months.ResultsMean number of IVT-AFL injections was 6.0 (all patients, n=513), 7.2 (regular cohort, n=102), 6.1 (irregular cohort with three initial monthly injections, n=266) and 5.2 (irregular cohort without three initial monthly injections, n=60). Overall mean gain in BCVA at 12 months was 5 letters; +7.1 letters (regular cohort) and +5.6 letters (irregular cohort with three initial monthly injections), both p<0.001 versus baseline, and –1.1 letters (irregular cohort without three initial monthly injections), p=0.669. Improvements in BCVA were also significantly greater in the regular cohort (p<0.001) and irregular cohort with three initial monthly injections (p=0.003) compared with the irregular cohort without three initial monthly injections. Ocular and non-ocular adverse events were reported in 14.7% and 17.4% of all patients, respectively.ConclusionTreatment-naïve patients with neovascular AMD receiving three initial monthly injections followed by regular or irregular injections over 12 months experienced better visual acuity outcomes than those receiving irregular treatment without three initial monthly injections.Trial registration numberNCT02279537. |
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| AbstractList | To evaluate 12-month outcomes in treatment-naïve patients with neovascular (wet) age-related macular degeneration (AMD) stratified by intravitreal aflibercept (IVT-AFL) regimen.OBJECTIVETo evaluate 12-month outcomes in treatment-naïve patients with neovascular (wet) age-related macular degeneration (AMD) stratified by intravitreal aflibercept (IVT-AFL) regimen.Patients included in the 12-month interim analysis of Real life of intravitreal Aflibercept In FraNce: oBservatiOnal Study in Wet AMD (RAINBOW), a 4-year, ongoing observational study conducted in France, were stratified by IVT-AFL dosing regimen. Safety (n=593) and effectiveness (n=428) data were analysed. Regimens included a regular cohort (three initial monthly IVT-AFL injections and ≥6 injections) and irregular cohorts (<6 injections) with and without three initial monthly injections. The main outcome measure was mean gain in best-corrected visual acuity (BCVA) at 12 months.METHODS AND ANALYSISPatients included in the 12-month interim analysis of Real life of intravitreal Aflibercept In FraNce: oBservatiOnal Study in Wet AMD (RAINBOW), a 4-year, ongoing observational study conducted in France, were stratified by IVT-AFL dosing regimen. Safety (n=593) and effectiveness (n=428) data were analysed. Regimens included a regular cohort (three initial monthly IVT-AFL injections and ≥6 injections) and irregular cohorts (<6 injections) with and without three initial monthly injections. The main outcome measure was mean gain in best-corrected visual acuity (BCVA) at 12 months.Mean number of IVT-AFL injections was 6.0 (all patients, n=513), 7.2 (regular cohort, n=102), 6.1 (irregular cohort with three initial monthly injections, n=266) and 5.2 (irregular cohort without three initial monthly injections, n=60). Overall mean gain in BCVA at 12 months was 5 letters; +7.1 letters (regular cohort) and +5.6 letters (irregular cohort with three initial monthly injections), both p<0.001 versus baseline, and -1.1 letters (irregular cohort without three initial monthly injections), p=0.669. Improvements in BCVA were also significantly greater in the regular cohort (p<0.001) and irregular cohort with three initial monthly injections (p=0.003) compared with the irregular cohort without three initial monthly injections. Ocular and non-ocular adverse events were reported in 14.7% and 17.4% of all patients, respectively.RESULTSMean number of IVT-AFL injections was 6.0 (all patients, n=513), 7.2 (regular cohort, n=102), 6.1 (irregular cohort with three initial monthly injections, n=266) and 5.2 (irregular cohort without three initial monthly injections, n=60). Overall mean gain in BCVA at 12 months was 5 letters; +7.1 letters (regular cohort) and +5.6 letters (irregular cohort with three initial monthly injections), both p<0.001 versus baseline, and -1.1 letters (irregular cohort without three initial monthly injections), p=0.669. Improvements in BCVA were also significantly greater in the regular cohort (p<0.001) and irregular cohort with three initial monthly injections (p=0.003) compared with the irregular cohort without three initial monthly injections. Ocular and non-ocular adverse events were reported in 14.7% and 17.4% of all patients, respectively.Treatment-naïve patients with neovascular AMD receiving three initial monthly injections followed by regular or irregular injections over 12 months experienced better visual acuity outcomes than those receiving irregular treatment without three initial monthly injections.CONCLUSIONTreatment-naïve patients with neovascular AMD receiving three initial monthly injections followed by regular or irregular injections over 12 months experienced better visual acuity outcomes than those receiving irregular treatment without three initial monthly injections.NCT02279537.TRIAL REGISTRATION NUMBERNCT02279537. To evaluate 12-month outcomes in treatment-naïve patients with neovascular (wet) age-related macular degeneration (AMD) stratified by intravitreal aflibercept (IVT-AFL) regimen. Patients included in the 12-month interim analysis of Real life of intravitreal Aflibercept In FraNce: oBservatiOnal Study in Wet AMD (RAINBOW), a 4-year, ongoing observational study conducted in France, were stratified by IVT-AFL dosing regimen. Safety (n=593) and effectiveness (n=428) data were analysed. Regimens included a regular cohort (three initial monthly IVT-AFL injections and ≥6 injections) and irregular cohorts (<6 injections) with and without three initial monthly injections. The main outcome measure was mean gain in best-corrected visual acuity (BCVA) at 12 months. Mean number of IVT-AFL injections was 6.0 (all patients, n=513), 7.2 (regular cohort, n=102), 6.1 (irregular cohort with three initial monthly injections, n=266) and 5.2 (irregular cohort without three initial monthly injections, n=60). Overall mean gain in BCVA at 12 months was 5 letters; +7.1 letters (regular cohort) and +5.6 letters (irregular cohort with three initial monthly injections), both p<0.001 versus baseline, and -1.1 letters (irregular cohort without three initial monthly injections), p=0.669. Improvements in BCVA were also significantly greater in the regular cohort (p<0.001) and irregular cohort with three initial monthly injections (p=0.003) compared with the irregular cohort without three initial monthly injections. Ocular and non-ocular adverse events were reported in 14.7% and 17.4% of all patients, respectively. Treatment-naïve patients with neovascular AMD receiving three initial monthly injections followed by regular or irregular injections over 12 months experienced better visual acuity outcomes than those receiving irregular treatment without three initial monthly injections. NCT02279537. ObjectiveTo evaluate 12-month outcomes in treatment-naïve patients with neovascular (wet) age-related macular degeneration (AMD) stratified by intravitreal aflibercept (IVT-AFL) regimen.Methods and analysisPatients included in the 12-month interim analysis of Real life of intravitreal Aflibercept In FraNce: oBservatiOnal Study in Wet AMD (RAINBOW), a 4-year, ongoing observational study conducted in France, were stratified by IVT-AFL dosing regimen. Safety (n=593) and effectiveness (n=428) data were analysed. Regimens included a regular cohort (three initial monthly IVT-AFL injections and ≥6 injections) and irregular cohorts (<6 injections) with and without three initial monthly injections. The main outcome measure was mean gain in best-corrected visual acuity (BCVA) at 12 months.ResultsMean number of IVT-AFL injections was 6.0 (all patients, n=513), 7.2 (regular cohort, n=102), 6.1 (irregular cohort with three initial monthly injections, n=266) and 5.2 (irregular cohort without three initial monthly injections, n=60). Overall mean gain in BCVA at 12 months was 5 letters; +7.1 letters (regular cohort) and +5.6 letters (irregular cohort with three initial monthly injections), both p<0.001 versus baseline, and –1.1 letters (irregular cohort without three initial monthly injections), p=0.669. Improvements in BCVA were also significantly greater in the regular cohort (p<0.001) and irregular cohort with three initial monthly injections (p=0.003) compared with the irregular cohort without three initial monthly injections. Ocular and non-ocular adverse events were reported in 14.7% and 17.4% of all patients, respectively.ConclusionTreatment-naïve patients with neovascular AMD receiving three initial monthly injections followed by regular or irregular injections over 12 months experienced better visual acuity outcomes than those receiving irregular treatment without three initial monthly injections.Trial registration numberNCT02279537. Objective To evaluate 12-month outcomes in treatment-naïve patients with neovascular (wet) age-related macular degeneration (AMD) stratified by intravitreal aflibercept (IVT-AFL) regimen.Methods and analysis Patients included in the 12-month interim analysis of Real life of intravitreal Aflibercept In FraNce: oBservatiOnal Study in Wet AMD (RAINBOW), a 4-year, ongoing observational study conducted in France, were stratified by IVT-AFL dosing regimen. Safety (n=593) and effectiveness (n=428) data were analysed. Regimens included a regular cohort (three initial monthly IVT-AFL injections and ≥6 injections) and irregular cohorts (<6 injections) with and without three initial monthly injections. The main outcome measure was mean gain in best-corrected visual acuity (BCVA) at 12 months.Results Mean number of IVT-AFL injections was 6.0 (all patients, n=513), 7.2 (regular cohort, n=102), 6.1 (irregular cohort with three initial monthly injections, n=266) and 5.2 (irregular cohort without three initial monthly injections, n=60). Overall mean gain in BCVA at 12 months was 5 letters; +7.1 letters (regular cohort) and +5.6 letters (irregular cohort with three initial monthly injections), both p<0.001 versus baseline, and –1.1 letters (irregular cohort without three initial monthly injections), p=0.669. Improvements in BCVA were also significantly greater in the regular cohort (p<0.001) and irregular cohort with three initial monthly injections (p=0.003) compared with the irregular cohort without three initial monthly injections. Ocular and non-ocular adverse events were reported in 14.7% and 17.4% of all patients, respectively.Conclusion Treatment-naïve patients with neovascular AMD receiving three initial monthly injections followed by regular or irregular injections over 12 months experienced better visual acuity outcomes than those receiving irregular treatment without three initial monthly injections.Trial registration number NCT02279537. |
| Author | Dufour, Ingrid Cohen, Salomon Y Faure, Céline Kodjikian, Laurent Weber, Michel Aubry, Isabelle Coscas, Florence |
| AuthorAffiliation | 3 Centre Odéon , Paris , France 4 Clinique Saint-Martin , Ramsay Générale de Santé , Caen , France 6 Bayer Healthcare SAS , Loos , France 2 Centre Hospitalier de la Croix Rousse , Lyon , France 5 Centre Ophtalmologique des Arceaux , Montpellier , France 7 Centre d'Imagerie et de Laser , Paris , France 1 CHU Hôtel-Dieu , Nantes , France |
| AuthorAffiliation_xml | – name: 5 Centre Ophtalmologique des Arceaux , Montpellier , France – name: 1 CHU Hôtel-Dieu , Nantes , France – name: 2 Centre Hospitalier de la Croix Rousse , Lyon , France – name: 7 Centre d'Imagerie et de Laser , Paris , France – name: 3 Centre Odéon , Paris , France – name: 6 Bayer Healthcare SAS , Loos , France – name: 4 Clinique Saint-Martin , Ramsay Générale de Santé , Caen , France |
| Author_xml | – sequence: 1 givenname: Michel orcidid: 0000-0001-5884-1177 surname: Weber fullname: Weber, Michel email: weber.michel@bbox.fr organization: CHU Hôtel-Dieu, Nantes, France – sequence: 2 givenname: Laurent surname: Kodjikian fullname: Kodjikian, Laurent organization: Centre Hospitalier de la Croix Rousse, Lyon, France – sequence: 3 givenname: Florence surname: Coscas fullname: Coscas, Florence organization: Centre Odéon, Paris, France – sequence: 4 givenname: Céline surname: Faure fullname: Faure, Céline organization: Clinique Saint-Martin, Ramsay Générale de Santé, Caen, France – sequence: 5 givenname: Isabelle surname: Aubry fullname: Aubry, Isabelle organization: Centre Ophtalmologique des Arceaux, Montpellier, France – sequence: 6 givenname: Ingrid surname: Dufour fullname: Dufour, Ingrid organization: Bayer Healthcare SAS, Loos, France – sequence: 7 givenname: Salomon Y surname: Cohen fullname: Cohen, Salomon Y organization: Centre d'Imagerie et de Laser, Paris, France |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/32518833$$D View this record in MEDLINE/PubMed |
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ranibizumab in daily clinical practice: the LUMIERE study publication-title: Retina doi: 10.1097/IAE.0b013e31827b6324 – volume: 2 start-page: 539 year: 2018 article-title: Aflibercept for patients with neovascular age-related macular degeneration in routine clinical practice in Germany: Twelve-Month outcomes of PERSEUS publication-title: Ophthalmol Retina doi: 10.1016/j.oret.2017.09.017 – volume: 123 start-page: 337 year: 2016 article-title: First-Year visual acuity outcomes of providing aflibercept according to the view study protocol for age-related macular degeneration publication-title: Ophthalmology doi: 10.1016/j.ophtha.2015.09.039 – volume: 38 start-page: 450 year: 2006 article-title: Age-related macular degeneration--emerging pathogenetic and therapeutic concepts publication-title: Ann Med doi: 10.1080/07853890600946724 – volume: 35 start-page: 1787 year: 2015 article-title: Inhibition of ocular neovascularization by co-inhibition of VEGF-A and PlGF publication-title: Cell 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10.1016/j.oret.2017.09.017 – volume: 249 start-page: 653 year: 2011 article-title: Results of flexible ranibizumab treatment in age-related macular degeneration and search for parameters with impact on outcome publication-title: Graefes Arch Clin Exp Ophthalmol doi: 10.1007/s00417-011-1636-6 – volume: 28 start-page: 2369 year: 2014 article-title: Progressive dysfunction of the retinal pigment epithelium and retina due to increased VEGF-A levels publication-title: Faseb J doi: 10.1096/fj.13-248021 – volume: 119 start-page: 2537 year: 2012 article-title: Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration publication-title: Ophthalmology doi: 10.1016/j.ophtha.2012.09.006 – volume: 34 start-page: 703 year: 2017 article-title: A retrospective study of ranibizumab treatment regimens for neovascular age-related macular degeneration (nAMD) in Australia and the United Kingdom publication-title: Adv Ther doi: 10.1007/s12325-017-0483-1 – ident: 2025090109193267000_5.1.e000377.13 doi: 10.1007/s00417-011-1636-6 – ident: 2025090109193267000_5.1.e000377.30 doi: 10.1136/bjophthalmol-2016-309818 – volume: 60 start-page: 99 year: 1999 ident: 2025090109193267000_5.1.e000377.2 article-title: Common causes of vision loss in elderly patients publication-title: Am Fam Physician – ident: 2025090109193267000_5.1.e000377.9 doi: 10.1016/j.ajo.2009.01.024 – ident: 2025090109193267000_5.1.e000377.6 doi: 10.1056/NEJMoa062655 – ident: 2025090109193267000_5.1.e000377.15 doi: 10.1097/IAE.0b013e31827b6324 – volume: 29 start-page: 1453 year: 2015 ident: 2025090109193267000_5.1.e000377.28 article-title: Evaluating the impact of summer vacation on the visual acuity of AMD patients treated with ranibizumab publication-title: Eye doi: 10.1038/eye.2015.128 – volume: 2 start-page: 539 year: 2018 ident: 2025090109193267000_5.1.e000377.26 article-title: Aflibercept for patients with neovascular age-related macular degeneration in routine clinical practice in Germany: Twelve-Month outcomes of PERSEUS publication-title: Ophthalmol Retina doi: 10.1016/j.oret.2017.09.017 – ident: 2025090109193267000_5.1.e000377.10 doi: 10.1016/j.ophtha.2010.12.019 – ident: 2025090109193267000_5.1.e000377.14 doi: 10.1136/bjophthalmol-2014-305327 – ident: 2025090109193267000_5.1.e000377.11 doi: 10.1016/j.ophtha.2012.04.015 – volume: 35 start-page: 1787 year: 2015 ident: 2025090109193267000_5.1.e000377.4 article-title: Inhibition of ocular neovascularization by co-inhibition of VEGF-A and PlGF publication-title: Cell Physiol Biochem doi: 10.1159/000373990 – volume: 35 start-page: 1743 year: 2015 ident: 2025090109193267000_5.1.e000377.29 article-title: Changes in visual acuity in patients with wet age-related macular degeneration treated with intravitreal ranibizumab in daily clinical practice: the twin study publication-title: Retina doi: 10.1097/IAE.0000000000000548 – volume: 34 start-page: 703 year: 2017 ident: 2025090109193267000_5.1.e000377.25 article-title: A retrospective study of ranibizumab treatment regimens for neovascular age-related macular degeneration (nAMD) in Australia and the United Kingdom publication-title: Adv Ther doi: 10.1007/s12325-017-0483-1 – ident: 2025090109193267000_5.1.e000377.1 doi: 10.1080/07853890600946724 – ident: 2025090109193267000_5.1.e000377.22 doi: 10.1016/j.ophtha.2015.09.039 – volume: 174 start-page: 160 year: 2017 ident: 2025090109193267000_5.1.e000377.21 article-title: Long-Term outcomes of aflibercept treatment for neovascular age-related macular degeneration in a clinical setting publication-title: Am J Ophthalmol doi: 10.1016/j.ajo.2016.09.038 – volume: 7 start-page: 361 year: 2018 ident: 2025090109193267000_5.1.e000377.20 article-title: Three-Year outcomes of aflibercept treatment for neovascular age-related macular degeneration: evidence from a clinical setting publication-title: Ophthalmol Ther doi: 10.1007/s40123-018-0139-5 – ident: 2025090109193267000_5.1.e000377.16 – volume: 2 start-page: 539 year: 2018 ident: 2025090109193267000_5.1.e000377.24 article-title: Aflibercept for patients with neovascular age-related macular degeneration in routine clinical practice in Germany publication-title: Ophthalmol Retina doi: 10.1016/j.oret.2017.09.017 – volume: 255 start-page: 1259 year: 2017 ident: 2025090109193267000_5.1.e000377.8 article-title: Fundamental principles of an anti-VEGF treatment regimen: optimal application of intravitreal anti-vascular endothelial growth factor therapy of macular diseases publication-title: Graefes Arch Clin Exp Ophthalmol doi: 10.1007/s00417-017-3647-4 – ident: 2025090109193267000_5.1.e000377.17 doi: 10.1016/j.ophtha.2013.08.011 – ident: 2025090109193267000_5.1.e000377.19 – ident: 2025090109193267000_5.1.e000377.5 doi: 10.1007/s10456-011-9249-6 – ident: 2025090109193267000_5.1.e000377.7 doi: 10.1056/NEJMoa054481 – ident: 2025090109193267000_5.1.e000377.18 doi: 10.1016/j.ophtha.2012.09.006 – ident: 2025090109193267000_5.1.e000377.3 doi: 10.1096/fj.13-248021 – volume: 4 year: 2019 ident: 2025090109193267000_5.1.e000377.23 article-title: Effectiveness and safety of intravitreal aflibercept in patients with wet age-related macular degeneration treated in routine clinical practices across France: 12-month outcomes of the rainbow study publication-title: BMJ Open Ophthalmol doi: 10.1136/bmjophth-2017-000109 – ident: 2025090109193267000_5.1.e000377.12 doi: 10.1016/j.ophtha.2012.10.014 – volume: 9 start-page: 2243 year: 2015 ident: 2025090109193267000_5.1.e000377.27 article-title: Current barriers to treatment for wet age-related macular degeneration (wAMD): findings from the wAMD patient and caregiver survey publication-title: Clin Ophthalmol doi: 10.2147/OPTH.S92548 |
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| Snippet | ObjectiveTo evaluate 12-month outcomes in treatment-naïve patients with neovascular (wet) age-related macular degeneration (AMD) stratified by intravitreal... To evaluate 12-month outcomes in treatment-naïve patients with neovascular (wet) age-related macular degeneration (AMD) stratified by intravitreal aflibercept... Objective To evaluate 12-month outcomes in treatment-naïve patients with neovascular (wet) age-related macular degeneration (AMD) stratified by intravitreal... |
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| SubjectTerms | Clinical medicine Diabetes Diabetic retinopathy drugs Macular degeneration Original Research Patients treatment medical Vascular endothelial growth factor vision |
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| Title | Impact of intravitreal aflibercept dosing regimens in treatment-naïve patients with neovascular age-related macular degeneration in routine clinical practice in France: results from the RAINBOW study |
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