PMID- 33378369 OWN - NLM STAT- MEDLINE DCOM- 20210305 LR - 20210305 IS - 1932-6203 (Electronic) IS - 1932-6203 (Linking) VI - 15 IP - 12 DP - 2020 TI - Ranibizumab treatment patterns in prior ranibizumab-treated neovascular age-related macular degeneration patients: Real-world outcomes from the LUMINOUS study. PG - e0244183 LID - 10.1371/journal.pone.0244183 [doi] LID - e0244183 AB - PURPOSE: To evaluate the effectiveness, safety, and treatment patterns of ranibizumab 0.5 mg in prior ranibizumab-treated patients with neovascular age-related macular degeneration (nAMD) enrolled in the LUMINOUS study. PATIENTS AND METHODS: LUMINOUS, a 5-year, prospective, multicenter, observational study, recruited 30,138 adult patients (treatment-naive or prior ranibizumab-treated or other ocular treatments) across all approved indications for ranibizumab. Patients were treated as per local ranibizumab label of participating countries. Here we report the mean change in visual acuity (VA) at Year 1, treatment exposure, overall incidence of ocular, non-ocular adverse events (AEs) and serious AEs (SAEs) in prior ranibizumab-treated nAMD patients (n = 16,167). RESULTS: At baseline, the mean (standard deviation [SD]) age of patients was 78.4 (9.0) years, 59.0% were female, and 80.0% were Caucasian. At Year 1 (n = 10,168), the mean (SD) VA change was -1.6 (12.6) letters (baseline VA: 58.3 [19.0] letters) with a mean (SD) of 4.7 (3.1) ranibizumab injections. Stratified by duration of prior ranibizumab treatment of <1 (n = 4,112), 1 to <2 (n = 2,095), 2 to <3 (n = 1,506), 3 to <4 (n = 1,123), 4 to <5 (n = 689), and >/=5 (n = 256) years, the mean (SD) VA change at Year 1 were -1.2 (13.5), -2.0 (12.3), -2.0 (11.3), -1.9 (11.8), -2.5 (10.9), and 0.0 (11.2) letters, respectively. Mean (SD) VA change in patients who received 6 injections over 1 year was -1.8 (13.8) and +0.5 (12.5) letters, respectively. The rate of ocular/non-ocular AEs and SAEs across all prior ranibizumab-treated patients over 5 years were 13.29%/23.02% and 0.84%/13.66%, respectively. CONCLUSIONS: Overall, regardless of the prior ranibizumab-treatment duration, VA was maintained in these patients at Year 1, and those receiving >/=6 injections showed a trend towards gaining letters. There were no new safety signals. These results may help inform routine clinical practice to appropriately treat nAMD patients with ranibizumab to achieve optimal visual outcomes. FAU - Holz, Frank G AU - Holz FG AD - Department of Ophthalmology, University of Bonn, Bonn, Germany. FAU - Minnella, Angelo M AU - Minnella AM AUID- ORCID: 0000-0001-5896-5313 AD - Department of Ophthalmology, Catholic University of Sacred Heart-Foundation "Policlinico Universitario A. Gemelli"-IRCCS, Rome, Italy. FAU - Tuli, Raman AU - Tuli R AD - The Retina Centre of Ottawa, Ottawa, Canada. AD - Department of Ophthalmology, University of Ottawa, Ottawa, Canada. FAU - Yoganathan, Pradeepa AU - Yoganathan P AD - Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada. AD - Windsor Eye Associates, Windsor, Ontario, Canada. AD - Kresge Eye Institute, Wayne State University, Detroit, Michigan, United States of America. FAU - Parikh, Soumil AU - Parikh S AD - Novartis Pharma AG, Basel, Switzerland. FAU - Hamilton, Robin AU - Hamilton R AUID- ORCID: 0000-0003-2861-8761 AD - Department of Medical Retina, Moorfields Eye Hospital NHS Foundation Trust and National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at Moorfields Eye Hospital, London, United Kingdom. CN - LUMINOUS study group LA - eng SI - ClinicalTrials.gov/NCT01318941 PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Observational Study PT - Pragmatic Clinical Trial PT - Research Support, Non-U.S. Gov't DEP - 20201230 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 - Drug Administration Schedule MH - Female MH - Humans MH - Long Term Adverse Effects/*epidemiology MH - Macular Degeneration/*drug therapy MH - Male MH - Ranibizumab/administration & dosage/adverse effects/*therapeutic use MH - Visual Acuity PMC - PMC7773197 COIS- Prof. Frank G Holz is a consultant for Acucela, Alcon, Bayer, Boehringer-Ingelheim, Galimedix, Genentech, Heidelberg Engineering, Khanghong, Lin-Bioscience, Novartis, Oxurion, Roche, Zeiss; receives grants from Bayer, Centervue, Genentech/Roche, Heidelberg Engineering, Novartis, and Zeiss. Prof. Angelo M Minnella is a consultant for Thea Laboratoire; receives grants (travel and meeting) from Allergan, Bayer Healthcare, Novartis Pharmaceutical, Thea Laboratoire. Dr. Raman Tuli is a member of advisory boards in Bayer, Novartis; receives grants from Apelis, Novartis, Roche. Prof. Pradeepa Yoganathan receives honoraria from Alimera Sciences, Genentech, and Knight Therapeutics including non-financial support from Bayer and Novartis. Dr. Soumil Parikh is an employee of Novartis Pharma AG, Basel, Switzerland. Dr. Robin Hamilton is a consultant for Allergan, Bayer Healthcare, Novartis Pharmaceuticals, and Roche; receives grants from Bayer Healthcare, Novartis Pharmaceuticals and Roche; receives lecture fees from Allergan, Bayer Healthcare, Novartis Pharmaceuticals and Roche. We state that this does not alter our adherence to PLOS ONE policies on sharing data and materials. EDAT- 2020/12/31 06:00 MHDA- 2021/03/06 06:00 PMCR- 2020/12/30 CRDT- 2020/12/30 17:13 PHST- 2020/01/17 00:00 [received] PHST- 2020/12/05 00:00 [accepted] PHST- 2020/12/30 17:13 [entrez] PHST- 2020/12/31 06:00 [pubmed] PHST- 2021/03/06 06:00 [medline] PHST- 2020/12/30 00:00 [pmc-release] AID - PONE-D-19-35289 [pii] AID - 10.1371/journal.pone.0244183 [doi] PST - epublish SO - PLoS One. 2020 Dec 30;15(12):e0244183. doi: 10.1371/journal.pone.0244183. eCollection 2020.