PMID- 32492069 OWN - NLM STAT- MEDLINE DCOM- 20200821 LR - 20200821 IS - 1932-6203 (Electronic) IS - 1932-6203 (Linking) VI - 15 IP - 6 DP - 2020 TI - Effectiveness and safety of ranibizumab 0.5 mg in treatment-naive patients with diabetic macular edema: Results from the real-world global LUMINOUS study. PG - e0233595 LID - 10.1371/journal.pone.0233595 [doi] LID - e0233595 AB - PURPOSE: To assess the one-year effectiveness and safety of ranibizumab 0.5 mg in treatment- naive patients with diabetic macular edema (DME) enrolled in the real-world LUMINOUS study. PATIENTS AND METHODS: 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-naive 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 (/=5), treatment exposure, and the overall adverse events (AEs) and serious AEs (SAEs) in treatment-naive DME patients. RESULTS: Of the 4,710 DME patients enrolled in the study, 1,063 were treatment-naive. 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 /=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. CONCLUSIONS: 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- naive 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. FAU - Mitchell, Paul AU - Mitchell P AUID- ORCID: 0000-0003-2470-3790 AD - Centre for Vision Research, Department of Ophthalmology and Westmead Institute for Medical Research, University of Sydney, Sydney, NSW, Australia. FAU - Sheidow, Tom G AU - Sheidow TG AD - Ivey Eye Institute, Schulich School of Medicine, Western University, Ontario, Canada. FAU - Farah, Michel E AU - Farah ME AUID- ORCID: 0000-0001-5951-0193 AD - Department of Ophthalmology, Federal University of Sao Paulo, Paulista School of Medicine, Sao Paulo, Brazil. FAU - Mahmood, Sajjad AU - Mahmood S AD - Royal Eye Hospital, Oxford Road, Manchester, United Kingdom. FAU - Minnella, Angelo M AU - Minnella AM AD - Institute of Ophthalmology, Catholic University "Sacro Cuore" Foundation "A. Gemelli", Rome, Italy. FAU - Eter, Nicole AU - Eter N AD - Department of Ophthalmology, University of Muenster Medical Center, Muenster, Germany. FAU - Eldem, Bora AU - Eldem B AD - Department of Ophthalmology, Hacettepe University, Faculty of Medicine, Sihhiye, Ankara, Turkey. FAU - Al-Dhibi, Hassan AU - Al-Dhibi H AUID- ORCID: 0000-0002-0621-1234 AD - Vitreoretinal and Uveitis Division, King Khaled Eye Specialist Hospital, Riyadh, Kingdom of Saudi Arabia. FAU - Macfadden, Wayne AU - Macfadden W AD - Novartis Pharma AG, Basel, Switzerland. FAU - Parikh, Soumil AU - Parikh S AD - Novartis Pharma AG, Basel, Switzerland. FAU - Dunger-Baldauf, Cornelia AU - Dunger-Baldauf C AD - Novartis Pharma AG, Basel, Switzerland. FAU - Mahgoub, Mohamed M AU - Mahgoub MM AD - Ain-Shams University, Universidad de El Cairo, Cairo, Egypt. FAU - Schmidt-Erfurth, Ursula AU - Schmidt-Erfurth U AD - Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria. CN - LUMINOUS study investigators LA - eng SI - ClinicalTrials.gov/NCT01318941 PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20200603 PL - United States TA - PLoS One JT - PloS one JID - 101285081 RN - 0 (Angiogenesis Inhibitors) RN - ZL1R02VT79 (Ranibizumab) SB - IM MH - Aged MH - Aged, 80 and over MH - Angiogenesis Inhibitors/administration & dosage/adverse effects/*therapeutic use MH - Diabetic Retinopathy/*complications/*drug therapy MH - Female MH - Follow-Up Studies MH - Humans MH - Intravitreal Injections MH - Macular Edema/*complications/*drug therapy MH - Male MH - Middle Aged MH - Prospective Studies MH - Ranibizumab/administration & dosage/adverse effects/*therapeutic use MH - Treatment Outcome MH - Visual Acuity/drug effects PMC - PMC7269267 COIS- 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: Cristalia, Latinofarma; Research grant: Fapesp, Capes, CNPq Sajjad Mahmood: Research Grant - Bayer, and Novartis; Personal Fees - Alcon, Allergan, Bayer, and Novartis. Angelo M. Minnella: Consultant - Thea Laboratoire; Travel and meeting grant- Allergan, Bayer, Novartis, Thea. 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. EDAT- 2020/06/04 06:00 MHDA- 2020/08/22 06:00 PMCR- 2020/06/03 CRDT- 2020/06/04 06:00 PHST- 2019/07/26 00:00 [received] PHST- 2020/05/08 00:00 [accepted] PHST- 2020/06/04 06:00 [entrez] PHST- 2020/06/04 06:00 [pubmed] PHST- 2020/08/22 06:00 [medline] PHST- 2020/06/03 00:00 [pmc-release] AID - PONE-D-19-21092 [pii] AID - 10.1371/journal.pone.0233595 [doi] PST - epublish SO - PLoS One. 2020 Jun 3;15(6):e0233595. doi: 10.1371/journal.pone.0233595. eCollection 2020.