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Abstract
Background/aims To monitor treatment-naïve patients with wet age-related macular degeneration (wet AMD) receiving intravitreal aflibercept (IVT-AFL) in France.
Methods RAINBOW (Real life use of intravitreal Aflibercept In FraNce - 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.
Results 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)µm 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<0.001 vs baseline). The mean (SD) CRT reduction was –108.7 (146.8)µm and –116.4 (150.4)µm (loading dose) at month 12 (p<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.
Conclusion This 12-month interim analysis showed that IVT-AFL was associated with sustained improvements in a real-world setting. The RAINBOW results are consistent with the VIEW clinical studies.
Trial registration number NCT02279537 Pre-results.
- intravitreal aflibercept
- wet age-related macular degeneration
- real-world evidence
- RAINBOW
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Footnotes
Contributors MW contributed to the design; data acquisition, analysis and interpretation; and preparation and final review of the manuscript. LV contributed to the design; data acquisition, analysis and interpretation; and preparation and final review of the manuscript. FC contributed to the design; data acquisition, analysis and interpretation; and preparation and final review of the manuscript.CF contributed to the design; data acquisition, analysis and interpretation; and preparation and final review of the manuscript. IA contributed to the design; data acquisition, analysis and interpretation; and preparation and final review of the manuscript. S-Y C contributed to the design; data acquisition, analysis and interpretation; and preparation and final review of the manuscript.
Funding The RAINBOW study was funded by Bayer Pharmaceuticals. The funding organisation participated in the design and conduct of the study, analysis of the data and preparation of the manuscript.
Competing interests MW: Alcon, Alimera, Allergan, Bayer, Novartis, Thea; FC: Allergan, Bayer, Novartis, Roche; CF: Alcon, Bayer, Novartis; IA: Bayer; Novartis; S-YC: Alcon, Allergan, Bayer, Novartis, Thea.
Ethics approval CCTIRS and CNIL.
Provenance and peer review Not commissioned; externally peer reviewed.
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Collaborators The RAINBOW study investigators: Professor Salomon Yves Cohen, Dr Patrick Simon, Dr Alain Donati, Dr Valérie Krivosic, Dr Martine Mauget Faysse, Dr Frédéric Queguiner, Dr Sophie Navarre, Dr Concetta Li Calzi, Dr Elodie Bousquet, Dr Frédéric Chiambaretta, Dr Sylvia Nghiem-Buffet, Professor Catherine Creuzot Garcher, Dr Isabelle Aknin, Professor Michel Weber, Dr Sébastien Bruneau, Dr Bertille Tourame de Massiac, Dr Jean-François Boulet, Dr Aude Danan Husson, Dr Mathieu Lehmann, Dr Eve Rousseau, Dr Franck Fajnkuchen, Dr Joël Uzzan, Dr Saddek Mohand Said, Dr Olivier Lebreton, Dr Houiem Jeguirim, Professor Carl Arndt, Dr Bénédicte Briend Joulain, Dr Corinne Gonzalez, Professor Frédéric Matonti, Dr Isabelle Sillaire Houtmann, Dr Gabriel Quentel, Dr Amélie Lecleire-Collet, Dr Jean-François Girmens, Dr Hélène Masse, Dr Claire Scemmama, Dr Jonathan Benesty, Dr Anne Robinet Combes, Professor Corinne Dot, Dr Jean-Christophe Courjaret, Dr Stéphane Dumas, Dr Vincent Parier, Dr Christian Delhay, Dr Martine Ullern, Professor Stéphanie Baillif, Dr Ghislaine Ducos de Lahitte, Dr Tony Garcia, Dr Joël Gambrelle, Dr Emilie Agard, Dr Bernard Joannot, Dr Sylvain Blanchard, Dr Valérie Le Tien, Professor Jean-Claude Quintyn, Dr Franck Becquet, Dr Abdelghani Asrarguis, Dr Laurent Velasque, Dr Mickaël Afriat, Dr Christiane Ramahefasolo, Dr Hussam El Chehab, Dr Arnaud George, Dr Philippe Verdier, Dr Dagmar Kuhn, Professor Laurent Kodjikian, Dr Cécilia Leal, Dr Laurence Rosier, Professor Solange Milazzo, Dr Olga Kirsch, Dr Aurélie Russo, Dr Charles Pêcheur, Professor Christophe Chiquet, Dr Isabelle Aubry Quenet, Dr Nabil Salame, Dr Zainab Bentaleb, Dr Violaine Colasse Marthelot, Dr Marcel Dominguez, Dr Mounir Benzerroug, Dr Laurent Khaitrine, Dr Nicolas Alfonsi, Dr Alain Simoni, Professor Florent Aptel, Dr Caroline Serny, Professor Jean-François Korobelnik, Dr Thibaud Mathis, Dr Maddalena Quaranta-El-Maftouhi, Dr Eric Fourmaux, Dr Andrei Drimbea, Dr Benjamin Guigui, Dr Vincent Paoli, Dr Frédéric Sanian, Dr Thierry Zhou, Dr Florence Coscas, Dr France Combillet, Dr Olivier Jankowski, Professor Maher Saleh, Dr Hassiba Oubraham, Dr Karim Atmani, Dr Virginie Martinet, Dr Addel Chibani, Dr Nicolas Chobeaux, Dr Ralitsa Hubanova, Dr Catherine Francais, Professor Marie-Noëlle Delyfer, Professor Ramin Tadayoni, Dr Sébastien Guigou, Professor Nicolas Leveziel, Dr Sandrine Allieu, Dr Henrik Sagnieres, Professor Thi Ha ChauTran, Dr Nathalie Massamba, Dr Catherine Favard, Dr Marie-Bénédicte Rougier, Dr Ali Erginay, Dr Caroline Marc, Dr Michèle Boissonnot, Dr Charlotte Rohart, Dr Hatem Zeghidi, Professor Gisèle Soubrane and Dr Piotr Krawczyk.
Presented at Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) (1–5 May 2016, Seattle, Washington). 16th European Society of Retina Specialists Congress (16th EURETINA) (08–11 September 2016 / Copenhagen, Denmark). Imaging & Managing Macular Diseases (Maculart) meeting (2–4 July 2017; Paris, France). 123e Congres de la Societe Francaise d’Ophtalmologie (SFO 123rd) Congress (05-09 May 2017, France, Paris). 49th Annual Congress of the Royal Australian and New Zealand College of Ophthamologists (RANZCO) (28 October to 01 November 2017, Perth, Australia).
Patient consent for publication Obtained.