Effectiveness and safety of ranibizumab 0.5 mg in treatment-naïve patients with diabetic macular edema: Results from the real-world global LUMINOUS study.

To assess the one-year effectiveness and safety of ranibizumab 0.5 mg in treatment- naïve patients with diabetic macular edema (DME) enrolled in the real-world LUMINOUS study. A 5-year, prospective, observational, open-label, global study which recruited 30,138 patients across all approved indications. Consenting patients (≥18 years) who were treatment-naïve or previously treated with ranibizumab or other ocular treatments were treated as per the local ranibizumab label. Here, we present the change in visual acuity (VA) (Early Treatment Diabetic Retinopathy Study letter score; primary treated eye) at Year 1, as well as the change in VA based on injection frequencies (≤4 and ≥5), treatment exposure, and the overall adverse events (AEs) and serious AEs (SAEs) in treatment-naïve DME patients. Of the 4,710 DME patients enrolled in the study, 1,063 were treatment-naïve. At baseline, mean age was 64.5 years, 54.7% were male, and 69.2% were white. At 1 year, mean VA letter score improved by +3.5 (n = 502) from a baseline of 57.7 with a mean of 4.5 injections. Presented by injection frequencies ≤4 and ≥5, VA letter score gains were 0.5 (n = 264) and 6.9 (n = 238) from baseline letter scores of 56.6 and 59.0, respectively. Over 5 years, the incidence of ocular/non-ocular AEs and SAEs was 7.2%/10.1% and 0.3%/5.8%, respectively. No endophthalmitis cases were reported. The LUMINOUS study included patients with DME with more diverse baseline characteristics than those in randomized clinical trials. The 1-year data showed improvement in VA with low number of injections in treatment- naïve patients with DME. Greater VA gains were observed in patients who received ≥5 injections. No new safety findings were identified. LUMINOUS confirms the effectiveness and safety of ranibizumab for the treatment of patients with DME in a real-world clinical practice.

Déclaration de conflit d'intérêts

Financial disclosures: Paul Mitchell: Consultant − Abbott, Allergan, Bayer, Genentech, Novartis, Roche. Tom G. Sheidow: Research support – Novartis, Pfizer; Advisory board – Novartis, Alcon, Bayer Michel E. Farah: Consultant: Allergan, Bayer, Novartis, Alcon, Zeiss; Advisor: Cristália, Latinofarma; Research grant: Fapesp, Capes, CNPq Sajjad Mahmood: Research Grant – Bayer, and Novartis; Personal Fees – Alcon, Allergan, Bayer, and Novartis. Angelo M. Minnella: Consultant – Theà Laboratoire; Travel and meeting grant- Allergan, Bayer, Novartis, Theà. Nicole Eter: Consultant – Allergan, Alimera, Bausch & Lomb, Bayer, Heidelberg Engineering, Novartis, Roche. Bora Eldem: Consultant – Alcon Laboratories, Bayer Healthcare, and Novartis. Hassan Al-Dhibi: Consultant –Bayer, AbbVie and Novartis. Wayne Macfadden: Employee of Novartis Pharma AG, Basel, Switzerland at the time of development of the manuscript. Soumil Parikh: Employee of Novartis Pharma AG, Basel, Switzerland. Cornelia Dunger-Baldauf: Employee of Novartis Pharma AG, Basel, Switzerland. Mohamed M. Mahgoub: Nothing to declare. Ursula Schmidt-Erfurth: Consultant – Alcon, Bayer, Boeringher-Ingelheim GmbH, and Novartis. We confirm that this does not alter our adherence to PLOS ONE policies on sharing data and materials.