El-Badawi Kamal, Scrivens Benjamin, Eke Oluwaniyi, Ismail Rehab, Kobayter Lina, Salvatore Serena
Ophthalmology Department, Bristol Eye Hospital, University Hospitals Bristol and Weston, Bristol, UK.
Medical Education department, Queen Elizabeth the Queen Mother Hospital, Margate, UK.
Clin Ophthalmol. 2025 May 16;19:1583-1591. doi: 10.2147/OPTH.S513009. eCollection 2025.
To evaluate the visual and anatomical outcomes of switching diabetic macular oedema (DMO) patients with suboptimal response to aflibercept 2mg to faricimab over a 12-month period.
This retrospective single centre study enrolled 62 eyes from 50 patients with diabetic macular oedema (DMO) who demonstrated a sub-optimal response to aflibercept 2mg. Sub-optimal response was defined by a central subfield thickness (CST) exceeding 325µm or greater than 20% increase from the best CST despite receiving aflibercept 2mg at intervals of 8 weeks or less. Patients had received at least six 4-weekly doses of aflibercept 2mg. Faricimab was administered as four intravitreal loading injections at 4-weekly intervals, followed by a treat-and-extend approach. Outcome measures, including best-recorded visual acuity (BRVA), CST, and treatment intervals, were assessed at baseline, post-loading (6.5 ± 1.9 weeks) and at the latest clinic review (57.1 ± 19.7 weeks). Statistical analysis included paired t-tests (normal distribution) and Wilcoxon signed-rank tests (non-normal distribution), with p < 0.05 considered statistically significant.
Mean age was 63.9 (±11.4) years, 56% participants were male. At baseline, the mean BRVA was 67.6 (±11.8) letters, and CST measured 406.4 (±105.9) µm. The initial mean treatment interval was 6.5 (±1.8) weeks. BRVA increased to 70.4 (±12.7) letters (=0.008), while CST reduced to 372.8 (±132.0) µm (=0.002). The mean injection interval extended to 7.4 (±2.6) weeks (=0.03). At the latest follow-up BRVA was maintained at 68.7 (±14.6) letters (=0.572), and CST reduced further to 343.1 (±117.5) µm (=0.020). At the final follow-up 53.2% were on ≥8-weekly intervals. The mean injection interval increased to 9.2 (±3.2) weeks (p < 0.001), and a mean of 7.92 (±2.53) faricimab injections was administered.
DMO patients with sub-optimal response to aflibercept 2mg experienced improved anatomical outcomes and extended treatment intervals while maintaining vision on faricimab, with no new safety concerns.
评估在12个月期间，将对阿柏西普2mg反应欠佳的糖尿病性黄斑水肿（DMO）患者转换为法西单抗治疗后的视力和解剖学结果。
这项回顾性单中心研究纳入了50例糖尿病性黄斑水肿（DMO）患者的62只眼，这些患者对阿柏西普2mg表现出欠佳反应。欠佳反应定义为中心子野厚度（CST）超过325µm，或尽管每8周或更短时间接受一次阿柏西普2mg治疗，但最佳CST仍增加超过20%。患者至少接受了六次每4周一次的阿柏西普2mg剂量治疗。法西单抗通过每4周一次的四次玻璃体内负荷注射给药，随后采用治疗并延长的方法。在基线、负荷注射后（6.5±1.9周）和最近一次临床复查（57.1±19.7周）评估包括最佳记录视力（BRVA）、CST和治疗间隔在内的结果指标。统计分析包括配对t检验（正态分布）和Wilcoxon符号秩检验（非正态分布），p<0.05被认为具有统计学意义。
平均年龄为63.9（±11.4）岁，56%的参与者为男性。基线时，平均BRVA为67.6（±11.8）字母，CST为406.4（±105.9）µm。初始平均治疗间隔为6.5（±1.8）周。BRVA增加到70.4（±12.7）字母（p=0.008），而CST降至372.8（±132.0）µm（p=0.002）。平均注射间隔延长至7.4（±2.6）周（p=0.03）。在最近一次随访时，BRVA维持在68.7（±14.6）字母（p=0.572），CST进一步降至343.1（±117.5）µm（p=0.020）。在最后一次随访时，53.2%的患者注射间隔≥8周。平均注射间隔增加到9.2（±3.2）周（p<0.001），平均注射了7.92（±2.53）次法西单抗。
对阿柏西普2mg反应欠佳的DMO患者在接受法西单抗治疗时，解剖学结果得到改善，治疗间隔延长，同时视力得以维持，且无新的安全问题。
