{"id":1315,"date":"2019-09-01T00:00:00","date_gmt":"2019-08-31T22:00:00","guid":{"rendered":"https:\/\/preprod.retinegallien.com\/publication\/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\/"},"modified":"2019-09-01T00:00:00","modified_gmt":"2019-08-31T22:00:00","slug":"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","status":"publish","type":"publication","link":"https:\/\/www.retinegallien.com\/en\/publication\/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\/","title":{"rendered":"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"},"content":{"rendered":"<p>British Medical Journal publication of &nbsp;RAINBOW Study results Michel Weber, <strong>Laurent Velasque<\/strong>, Florence Coscas,, C\u00e9line Faure, Isabelle Aubry, Salomon Y Cohen, on behalf of the RAINBOW study investigators<br \/>\n<strong>BMJ Open Ophthalmology&nbsp;2019;4:e000109.<\/strong><br \/><\/br \/><\/p>\n<p><strong>BMJ Open Ophthalmology&nbsp;2019;4:e000109.<\/strong><\/p>\n<p><strong>background\/aims&nbsp;<\/strong>To monitor treatment-na\u00efve patients with wet age-related macular degeneration (wet AMD) receiving intravitreal aflibercept (IVT-AFL) in France.&nbsp;<strong>Methods&nbsp;<\/strong>RAINBOW&nbsp;<strong>(<\/strong>Real life use of intravitreal Aflibercept In FraNce &#8211; oBservatiOnal study in Wet age- related macular degeneration) is an ongoing, observational, retrospective and prospective 4-year study to assess visual (primary), anatomical and safety outcomes following IVT- AFL treatment in wet AMD patients. We report the interim 12-month outcomes in patients who have already been enrolled.<\/p>\n<p><strong>results&nbsp;<\/strong>Safety data were analysed from 586 patients (safety analysis set); and effectiveness data were analysed from 502 patients with at least one follow-up (full-analysis set) and from 353 patients with visual acuity data at baseline and month 12. The mean (SD) best-corrected visual acuity (BCVA) was 56.7 (18.2) letters and the mean (SD) central retinal thickness (CRT) was 395.6 (140.5)<\/p>\n<p>\u03bcm at baseline. Most patients (76.9%) received a loading dose (first three injections within 90 days). The mean (SD) number of IVT-AFL injections over 12 months was 6.0 (2.1) and 6.6 (1.8) (patients who received a loading dose). The mean (SD) change in BCVA was 5.5 (15.0) letters and 6.8 (14.5) letters (patients who received a loading dose) at month 12 (p&lt;0.001 vs baseline). The mean (SD) CRT reduction was \u2013108.7 (146.8)\u03bcm and \u2013116.4 (150.4)\u03bcm (loading dose) at month 12 (p&lt;0.001 vs baseline). Overall, 118 (20.1%) patients experienced at least one treatment- emergent adverse event (TEAE), 1.2% experienced ocular TEAEs and 3.9% experienced serious AEs.<\/p>\n<p><strong>Conclusion&nbsp;<\/strong>This 12-month interim analysis showed that IVT-AFL was associated with sustained improvements in<br \/>\na real-world setting. The RAINBOW results are consistent with the VIEW clinical studies.<\/p>\n<p><strong>Trial registration number&nbsp;<\/strong>NCT02279537 Pre-results.<\/p>\n","protected":false},"featured_media":1316,"template":"","meta":{"_acf_changed":false,"inline_featured_image":false},"class_list":["post-1315","publication","type-publication","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<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 - R\u00e9tine Gallien<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.retinegallien.com\/en\/publication\/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\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"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 - R\u00e9tine Gallien\" \/>\n<meta property=\"og:description\" content=\"British Medical Journal publication of &nbsp;RAINBOW Study results Michel Weber, Laurent Velasque, Florence Coscas,, C\u00e9line Faure, Isabelle Aubry, Salomon Y Cohen, on behalf of the RAINBOW study investigators BMJ Open Ophthalmology&nbsp;2019;4:e000109. BMJ Open Ophthalmology&nbsp;2019;4:e000109. background\/aims&nbsp;To monitor treatment-na\u00efve patients with wet age-related macular degeneration (wet AMD) receiving intravitreal aflibercept (IVT-AFL) in France.&nbsp;Methods&nbsp;RAINBOW&nbsp;(Real life use of intravitreal [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.retinegallien.com\/en\/publication\/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\/\" \/>\n<meta property=\"og:site_name\" content=\"R\u00e9tine Gallien\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.retinegallien.com\/wp-content\/uploads\/2025\/03\/19.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"300\" \/>\n\t<meta property=\"og:image:height\" content=\"399\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.retinegallien.com\\\/en\\\/publication\\\/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\\\/\",\"url\":\"https:\\\/\\\/www.retinegallien.com\\\/en\\\/publication\\\/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\\\/\",\"name\":\"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 - 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