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Laurent Kodjikian,1 Amélie Lecleire-Collet,2 Corinne Dot,3 Marie-Laure Le Lez,4 Stéphanie Baillif,5 Ali Erginay,6 Eric Souied,7 Eric Fourmaux,8 Philippe Gain,9 Anne Ponthieux10 1Department of Ophthalmology, Croix-Rousse University Hospital, Lyon, France; 2Mathilde Clinic, Rouen, France; 3Department of Ophthalmology, Desgenettes Military Hospital, Lyon, France and French Military Health Service Academy, Val-de-Grâce, Paris, France; 4Ophthalmology Department, Centre Hospitalier Regional Universitaire de Tours, Tours, France; 5Department of Ophthalmology, Centre Hospitalier Universitaire de Nice, Hôpital Pasteur-2, Nice, France; 6Department of Ophthalmology, Lariboisière Hospital, AP HP, University Paris-Diderot Paris-7, Paris, France; 7Department of Ophthalmology, Hospital Intercommunal de Creteil, University Paris Est Creteil, Creteil, France; 8Centre Gallien, Bordeaux, France; 9Ophthalmology Department, University Hospital, Saint-Etienne, France, Corneal Graft Biology, Engineering and Imaging Laboratory, BiiGC, EA2521, Federative Institute of Research in Sciences and Health Engineering, Faculty of Medicine, Jean Monnet University, Saint‐Etienne, France; 10Novartis Pharma SAS, Rueil-Malmaison, FranceCorrespondence: Laurent KodjikianDepartment of Ophthalmology, Croix-Rousse University Hospital, 103 Grande Rue de la Croix-Rousse, Lyon, 69004, FranceTel +33 4 26 10 94 29Fax + 33 4 72 07 26 45Email Kodjikian.laurent@wanadoo.frPurpose: To evaluate the real-world effectiveness of intravitreal ranibizumab 0.5 mg (Lucentis) in improving visual acuity (VA) in adults with decreased VA due to diabetic macular edema (DME).Patients and Methods: Real-world prospective observational 24-month study. Ranibizumab-naïve patients (n=116) were enrolled, treated and followed up according to investigators’ usual procedures. Outcomes included change from baseline to month 24 in best-corrected VA (BCVA; primary outcome), central retinal thickness (CRT), treatment exposure and safety.Results: Overall, 62.9% of patients completed the study per protocol, 68.6% completed the induction phase (first three injections one month apart). On average, patients had 12.5 ophthalmologist visits and 5.74 injections in year 1, decreasing to 4.6 visits and 1.94 injections in year 2. Mean baseline BCVA was 58.4 letters, mean gain at M24 was +6.08 letters (95% CI: 2.95, 9.21). Gains were higher for patients who completed induction, and for patients who did not switch treatment. Mean CRT improved by 149.17 μm at M24. There were no new safety signals. BCVA variation of ≥ 6 letters by M3 was predictive of BCVA gains at M24 (p=0.007), as was hypertension medication at baseline (p=0.022).Conclusion: Real-world ranibizumab treatment improved VA in DME patients, despite fewer injections than recommended.Keywords: real-world study, retinal thickness, visual acuity, switch, induction

Thi Ha Chau Tran,1 Ali Erginay,2 Stephane Verdun,3 Eric Fourmaux,4 Jean-François Le Rouic,5 Joel Uzzan,6 Solange Milazzo7 ,† Stephanie Baillif,8 Laurent Kodjikian9 1Service d’Ophtalmologie, Université Catholique de Lille, Faculté de Médecine et Maieutique, INSERM U1171, Lille, France; 2Service d’Ophtalmologie, Hôpital Lariboisière APHP, Universite de Paris, Paris, France; 3Département de Recherche Médicale, Groupement des Hôpitaux Catholiques de Lille, Lille, France; 4Centre Rétine Gallien, Bordeaux, France; 5Institut Ophtalmologique de l’Ouest Jules Verne, Ophtalliance, Nantes, France; 6Clinique Mathilde, Rouen, France; 7Service d’Ophtalmologie, Centre Hospitalier Universitaire d’Amiens Picardie, Université de Picardie Jules Verne, Amiens, France; 8Service d’Ophtalmologie, Centre Hospitalier Université Côte d’Azur, Université Côte d’Azur, Nice, France; 9Service d’Ophtalmologie, Croix Rousse Hospital, Hospice Cilvils de Lyon 1, Université de Lyon 1, Lyon, France†Solange Milazzo passed away on March 23, 2019Correspondence: Thi Ha Chau TranService d’Ophtalmologie, Université Catholique de Lille, Faculté de Médecine et Maieutique, INSERM U1171, Boulevard de Belfort, BP387, Lille, Cedex, 59021, FranceTel +33 3 20 87 74 42Fax + 33 20 87 75 58Email tran.hachau@ghicl.netAim: To evaluate the efficacy of intravitreal Aflibercept injection (IAI) for vitrectomized eyes with diabetic macular edema (DME) at one year.Methods: This is a prospective, non-comparative, multicenter observational study including diabetic patients whose HbA1c is < 9%, with visual acuity between 20/400 to 20/40 due to DME, who have undergone vitrectomy since at least 3 months before the first aflibercept injection. Treatment protocol included 5 monthly aflibercept injection followed by a ProReNata regimen during the first year. Visual acuity, OCT findings and number of IAI were assessed at 6 months and one year.Results: Forty-six eyes were included. Indications for vitrectomy were epiretinal membrane (58.7%), intravitreal hemorrhage (26.1%), and vitreomacular traction (8.7%), retinal detachment (4.3%), and other cause (4.3%). Median duration of macular edema was 3 years. Median interval between vitrectomy and first visit was 9 months. Thirty eyes were non-naïve and received previously thermal laser (44.3%), intravitreal injection of triamcinolone (26.7%), of ranibizumab (70%), of dexamethasone implant (36.7%), or bevacizumab (6.7%). Data was available for 35 eyes at 1 year. Visual gain was significant, +6 letters (p < 0.001) and central subfield thickness (CST) decreased significantly (− 108μm, p < 0.001) at 1 year. Mean number of injections was 9.3 and mean interval injection was 5.8 weeks.Conclusion: These results suggest that IAI may be beneficial in vitrectomized eyes with refractory DME which require frequent injections to obtain visual and anatomical improvement.Clinical Trial Registration: http://www.clinicaltrials.gov, registration Number NCT02874859.Keywords: aflibercept, diabetic macular edema, DME, vitrectomy, anti-VEGF