PMID- 34007153 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220423 IS - 1177-5467 (Print) IS - 1177-5483 (Electronic) IS - 1177-5467 (Linking) VI - 15 DP - 2021 TI - Real-World Effectiveness, Treatment Pattern, and Safety of Ranibizumab in Korean Patients with Neovascular Age-Related Macular Degeneration: Subgroup Analyses from the LUMINOUS Study. PG - 1995-2011 LID - 10.2147/OPTH.S303884 [doi] AB - PURPOSE: To evaluate the real-world effectiveness, treatment patterns, and safety of ranibizumab in Korean patients with neovascular age-related macular degeneration (nAMD). METHODS: LUMINOUS is a 5-year, global, prospective, observational, open-label study. Adults aged >/=18 years who were either treatment-naive or prior-treated were enrolled and treated with ranibizumab 0.5 mg as per the local label. Outcome measures included mean (+/- standard deviation [SD]) changes from baseline in visual acuity (VA) and central retinal thickness (CRT), and rate of ocular and non-ocular adverse events (AEs). RESULTS: Overall, 367 Korean patients with nAMD (152 treatment-naive and 215 prior-treated) were enrolled. The mean (SD) VA changes from baseline at 1-year were +10.1 (+/-21.77; P=0.0005) and +1.4 (+/-15.17; P=0.2142) Early Treatment Diabetic Retinopathy Study letters, with mean numbers of injections of 5.2 and 3.4 in the treatment-naive and prior-treated groups, respectively. VA gains were greater in patients with lower baseline VA, who received a loading dose, and with polypoidal choroidal vasculopathy (PCV). Multivariate logistic regression analyses demonstrated younger age, worse baseline VA, and those who received loading dose being associated with higher odds of any gain in VA at 1 year (P<0.05). Mean (SD) CRT changes from baseline were -126.7 (+/-174.90) microm (P<0.0001) and +10.8 (+/-89.62) microm (P=0.5833) in the treatment-naive and prior-treated groups, respectively, with greater reductions observed in patients with PCV. Ocular and non-ocular AEs were reported in 8.4% (n=31) and 10.1% (n=37) of patients, respectively. CONCLUSION: The LUMINOUS study confirms real-world effectiveness and safety of ranibizumab in Korean patients with nAMD; factors including age, baseline VA, and loading-dose were associated with VA gain at one-year post-treatment. CI - (c) 2021 Sagong et al. FAU - Sagong, Min AU - Sagong M AUID- ORCID: 0000-0003-4140-5015 AD - Department of Ophthalmology, Yeungnam University College of Medicine, Daegu, Korea. FAU - Woo, Se Joon AU - Woo SJ AUID- ORCID: 0000-0003-3692-7169 AD - Department of Ophthalmology, Seoul National University Bundang Hospital, Seongnam, Korea. FAU - Lee, Youkyung AU - Lee Y AUID- ORCID: 0000-0002-0633-3557 AD - Novartis Korea Ltd., Seoul, Korea. CN - LUMINOUS study investigators from South Korea LA - eng PT - Journal Article DEP - 20210511 PL - New Zealand TA - Clin Ophthalmol JT - Clinical ophthalmology (Auckland, N.Z.) JID - 101321512 PMC - PMC8123958 OTO - NOTNLM OT - neovascular age-related macular degeneration OT - polypoidal choroidal vasculopathy OT - ranibizumab OT - real-world COIS- Youkyung Lee is a full time employee of Novartis Korea Ltd. Se Joon Woo is a paid consultant of Samsung Bioepis Inc., Songdo, South Korea and Novelty Nobility Inc., Seoul, South Korea; reports grants from Curacle, Novartis, Bayer, Allergan, Abbie, Alcon, SCAI Therapeutics, Alteogen, and Philophos, and is a co-founder of RetiMark Inc., in Seoul, South Korea. Dr Min Sagong reports grants from Novartis, Allergan, and Bayer, outside the submitted work. The authors report no other conflicts of interest in this work. EDAT- 2021/05/20 06:00 MHDA- 2021/05/20 06:01 PMCR- 2021/05/11 CRDT- 2021/05/19 06:44 PHST- 2021/02/09 00:00 [received] PHST- 2021/04/14 00:00 [accepted] PHST- 2021/05/19 06:44 [entrez] PHST- 2021/05/20 06:00 [pubmed] PHST- 2021/05/20 06:01 [medline] PHST- 2021/05/11 00:00 [pmc-release] AID - 303884 [pii] AID - 10.2147/OPTH.S303884 [doi] PST - epublish SO - Clin Ophthalmol. 2021 May 11;15:1995-2011. doi: 10.2147/OPTH.S303884. eCollection 2021.