Real-World Effectiveness, Treatment Pattern, and Safety of Ranibizumab in Korean Patients with Neovascular Age-Related Macular Degeneration: Subgroup Analyses from the LUMINOUS Study

Abstract

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-naïve 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-naïve and 215 priortreated) 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-naïve 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) µm (P<0.0001) and +10.8 (±89.62) µm (P=0.5833) in the treatment-naïve and prior-treated groups, respectively, with greater reductions observed in patients with PCV. Ocular and nonocular 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 loadingdose were associated with VA gain at one-year post-treatment.

A real-world study assessing the impact of retinal fluid on visual acuity outcomes in patients with neovascular age-related macular degeneration in Korea

“…The number of injections and visits for treatment-naive patients with nAMD was 5.54 and 9.51, respectively, in year 1, and 3.48 and 7.10, respectively, in year 2. This was consistent with the real-world ranibizumab treatment pattern for the Korean patient population with nAMD in the LUMINOUS study, in which treatment-naive patients received 5.2 injections and 9.2 monitoring visits by year 1 43 . The number of injections and visits was relatively higher than that in real-world studies conducted in other regions 44 – 46 but was relatively lower than that in a study conducted in the US 47 .…”

“…Overall, the findings of this study are clinically meaningful as they reflect the actual clinical settings in South Korea and provide insights to fluid management strategies. The demographics and clinical characteristics of the study population were consistent with that reported in previous real-world studies from Korea 6 , 43 . Further, the study included a large sample population of 600 nAMD patients, adding strength to the findings.…”

Treat-and-Extend Regimens for the Management of Neovascular Age-related Macular Degeneration and Polypoidal Choroidal Vasculopathy: Consensus and Recommendations From the Asia-Pacific Vitreo-retina Society

“…[7][8][9][11][12][13][14] Over the past decade, major clinical trials and real-world studies worldwide have demonstrated the efficacy and safety of intravitreal anti-VEGF agents for the treatment of nAMD and PCV. 12,[15][16][17][18][19][20][21] Typically, 3 main approaches for the administration of intravitreal anti-VEGF injections are employed: fixed dosing regimens, "reactive" pro re nata (PRN) dosing regimens (ie, treatment on an as-needed basis), and "proactive" treat-and-extend (T&E) dosing regimens. 3 Fixed dosing regimens require continuous monthly or bimonthly injections for at least 1 year.…”