Importance Aflibercept biosimilars can expand available treatment options in retinal diseases and have the potential to improve patient access to safe and effective therapy. Objective To establish equivalence in efficacy and similarity in safety, pharmacokinetics, and immunogenicity of SB15 and reference aflibercept (AFL) in neovascular age-related macular degeneration (nAMD). Design, Setting, and Participants This was a randomized double-masked parallel group phase 3 trial conducted at 56 centers in 10 countries from June 2020 to March 2022, including follow-up through 56 weeks. Of 549 screened participants, 449 participants 50 years and older with treatment-naive nAMD were included and randomly assigned to SB15 (n = 224) or AFL (n = 225). Key exclusion criteria included considerable scarring, fibrosis, atrophy, and hemorrhage. This report includes results up to the end of the parallel group period at week 32. Of the 449 randomized participants, 438 (97.6%) completed week 32 follow-up. Intervention Participants were randomized 1:1 to receive 2 mg of SB15 or AFL every 4 weeks for the first 12 weeks (3 injections), followed by dosing every 8 weeks up to week 48, with final assessments at week 56. Main Outcomes and Measures The primary end point was the change in best-corrected visual acuity (BCVA) from baseline to week 8 with predefined equivalence margins of −3 letters to 3 letters. Other key end points were changes in BCVA and central subfield thickness up to week 32, safety, pharmacokinetics, and immunogenicity. Results The mean (SD) age among the 449 included participants was 74.0 (8.1) years, and 250 participants (55.7%) were female. Baseline demographic characteristics and most disease characteristics were comparable between treatment groups. The least squares mean change in BCVA from baseline to week 8 in the SB15 group was equivalent to that in the AFL group (6.7 letters vs 6.6 letters, respectively; difference, 0.1 letters; 95% CI, −1.3 to 1.4). Comparable efficacy between treatment groups was maintained up to week 32 (least squares mean change from baseline in BCVA: SB15, 7.6 letters vs AFL, 6.5 letters; least squares mean change from baseline in central subfield thickness: SB15, −110.4 μm vs AFL, −115.7 μm). No clinically relevant differences were observed in the incidence of treatment-emergent adverse events (TEAEs) (SB15, 107/224 [47.8%] vs AFL, 98/224 [43.8%]) and ocular TEAEs in the study eye (SB15, 41/224 [18.3%] vs AFL, 28/224 [12.5%]). The serum concentration profiles and cumulative incidences of overall antidrug antibody positive participants were comparable. Conclusions and Relevance In this phase 3 randomized clinical trial, SB15 and AFL showed equivalent efficacy and comparable safety, pharmacokinetics, and immunogenicity in participants with nAMD. Trial Registration ClinicalTrials.gov Identifier: NCT04450329
Purpose: To compare the efficacy of intravitreal dexamethasone implants according to previous response to bevacizumab treatment in patients with diabetic macular edema (DME).Methods: Forty-nine eyes of 49 patients who received intravitreal dexamethasone implants for DME were reviewed retrospectively.Of these patients, 13 were treatment-naïve and 36 had previously received intravitreal injections of bevacizumab.Of the 36 previously treated patients, 24 comprised a refractory group showing no response to previous injections, and 12 comprised a responder group showing a response to previous treatments.The best-corrected visual acuity, central macular thickness (CMT), and retreatment percentages were assessed monthly for 6 months.Results: After the intravitreal dexamethasone implants, visual acuity improved significantly over 6 months in the treatment-naïve group, while in the responder group, a significant improvement in visual acuity was seen at the 2-month follow-up.In the refractory group, there was no significant improvement in visual acuity during the follow-up period.The CMT showed a significant decrease in all three groups, and there was no significant difference in the CMT among the three groups at any time point.Five patients in the treatment-naive group (38.5%), 19 patients in the refractory group (79.2%), and nine patients in the responder group (75.0%) needed retreatment for recurrent macular edema, and there was a significant difference among the three groups in the rate of recurrence (p = 0.034).Conclusions: In DME patients, intravitreal dexamethasone implants were associated with a significant anatomical improvement irrespective of previous bevacizumab treatment response.However, the treatment-naïve and responder groups showed improvements in visual acuity, whereas the refractory group showed limited improvement.
망막분지정맥폐쇄에 동반된 황반부종의 자연경과와 유리체강내 베바시주맙 주입술 결과의 비교 오현주⋅사공민⋅장우혁 영남대학교 의과대학 안과학교실 목적: 황반부종을 동반한 망막분지정맥폐쇄의 자연경과와 유리체강내 베바시주맙 주입술의 결과에 대하여 비교하고자 하였다.대상과 방법: 안저검사에서 망막분지정맥폐쇄로 인하여 황반부종이 동반된 환자 중 12개월 이상 추적관찰이 가능하였던 환자를 대상으 로 후향적으로 비교 분석하였다.2007년 2월을 전후하여 자연경과관찰군(관찰군: 27안)과, 베바시주맙을 유리체강내로 1회 주사 후 필요에 따라 시행한 군(주사군: 30안)으로 분류하여 1, 3, 6, 12개월의 최대교정시력 변화를 알아보았다.중심황반두께가 300 μm 이상 으로 지속되거나 이전보다 100 μm 이상 증가한 경우 재치료를 시행하였다.결과: 두 군에서 나이, 초진시력은 유의한 차이가 없었고, 주사군에서 평균 주사횟수는 2.7회였다.초진시와 3, 12개월의 최대교정시력 (logMAR
Abstract Background 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 per the local label. Outcome measures included mean (±standard deviation) 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 prior-treated) were enrolled. The mean 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 number of injections of 5.2 and 3.4 in the treatment-naïve and prior-treated groups, respectively. VA gains were greater in patients with worse 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 CRT changes from baseline were –126.7 (±174.90) µm ( P < 0.0001) and +10.8 (±89.52) µm ( P = 0.5833) in the treatment-naïve 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.
Abstract To evaluate the real-world treatment outcomes in patients with neovascular age-related macular degeneration (nAMD) in Korea, focusing on retinal fluid resolution. This multi-institutional retrospective chart review study, analyzed medical records of patients with nAMD (age ≥ 50 years) who received their first anti-vascular endothelial growth factor (VEGF) treatment in ophthalmology clinics across South Korea between January 2017 and March 2019. The primary endpoint was the proportion of patients with retinal fluid after 12 months of anti-VEGF treatment. The association between fluid-free period and VA gains was also evaluated. A total of 600 patients were enrolled. At baseline, 97.16% of patients had retinal fluid; after 12 months of anti-VEGF treatment, 58.10% of patients had persistent retinal fluid. VA improvements were relatively better in patients with absence of retinal fluid compared with presence of retinal fluid (+ 12.29 letters vs. + 6.45 letters at month 12; P < .0001). Longer duration of absence of retinal fluid over first 12 months correlated with better VA gains at month 12 ( P < .01). More than half of the study patients with nAMD had retinal fluid even after 12 months of treatment with their current anti-VEGF. Presence of retinal fluid was associated with relatively worse VA outcomes.
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