ETOILE: Real-World Evidence of 24 Months of Ranibizumab 0.5 mg in Patients with Visual Impairment Due to Diabetic Macular Edema.

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). 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. 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). Real-world ranibizumab treatment improved VA in DME patients, despite fewer injections than recommended.

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© 2021 Kodjikian et al.

Déclaration de conflit d'intérêts

AP is an employee of Novartis Pharma SAS, France. LK received consulting fees from Novartis related to the current paper and reports personal fees from Allergan, AbbVie, Alimera, Horus, Bayer, Novartis, Roche, and Thea, during the conduct of the study. ALC reports payment for enrollment of patients and data from Novartis, during the conduct of the study; consultant for Novartis, Bayer, and Allergan, outside the submitted work. CD reports personal fees for consulting from AbbVie, Bayer, Novartis, and Horus, during the conduct of the study. SB is a board member for Allergan, Novartis, Bayer and Horus Pharma, outside the submitted work. The authors report no other conflicts of interest in this work.