Callizo Josep, Ziemssen Focke, Bertelmann Thomas, Feltgen Nicolas, Vögeler Jessica, Koch Mirja, Eter Nicole, Liakopoulos Sandra, Schmitz-Valckenberg Steffen, Spital Georg
Department of Ophthalmology, Georg-August University, Goettingen, Germany.
Center for Ophthalmology, Eberhard Karl University of Tuebingen, Tuebingen, Germany.
Clin Ophthalmol. 2019 Nov 7;13:2167-2179. doi: 10.2147/OPTH.S209253. eCollection 2019.
The non-interventional OCEAN study (NCT02194803) evaluated frequency and monitoring of ranibizumab injections for retinal vein occlusion (RVO) in routine practice in Germany.
RVO patients (including branch and central RVO (BRVO/CRVO)) receiving ranibizumab were included. Best-corrected visual acuity (BCVA) testing, imaging and treatment were performed at the investigators' discretion and documented over 24 months.
Overall, 744 RVO patients (27% BRVO, 16% CRVO, remaining unspecified RVO) were included. For 74% of patients, data were available for the 12-month visit and for 56% for the 24-month visit. Mean baseline BCVA was 52.0 Early Treatment for Diabetic Retinopathy Study (ETDRS) letters (BRVO: 55.9, CRVO: 43.9). BCVA improved rapidly within the first 3 months, reaching 64.3 letters at 12 months and 64.7 at 24 months. CRVO patients showed less improvement than those with BRVO. Patients received a median of 4 (5) injections over 12 (24) months, with 100% of patients receiving injections at baseline, 70% at Month 1 and 81% at Month 2. Overall, 40% of patients demonstrated a ≥15 letter increase within the first 3 months (42% BRVO, 46% CRVO). Patients with low initial BCVA (<50 letters) showed greater improvement than patients with higher baseline BCVA. Due to considerable loss to follow-up, the number of injections and optical coherence tomography (OCT) examinations were not associated with the change in BCVA.
Patients with RVO in routine practice in Germany received fewer injections and fewer OCT examinations than in clinical trials. CRVO patients showed less and later improvement compared to BRVO patients.
非干预性OCEAN研究（NCT02194803）评估了德国常规临床实践中雷珠单抗治疗视网膜静脉阻塞（RVO）的注射频率及监测情况。
纳入接受雷珠单抗治疗的RVO患者（包括分支视网膜静脉阻塞和中央视网膜静脉阻塞（BRVO/CRVO））。最佳矫正视力（BCVA）检测、影像学检查及治疗由研究者自行决定，并记录24个月的数据。
共纳入744例RVO患者（27%为BRVO，16%为CRVO，其余为未明确分类的RVO）。74%的患者有12个月随访数据，56%的患者有24个月随访数据。平均基线BCVA为52.0糖尿病视网膜病变早期治疗研究（ETDRS）视力表字母数（BRVO：55.9，CRVO：43.9）。BCVA在最初3个月内迅速改善，12个月时达到64.3字母数，24个月时达到64.7字母数。CRVO患者的改善程度低于BRVO患者。患者在12（24）个月内接受的注射次数中位数为4（5）次，100%的患者在基线时接受注射，70%的患者在第1个月接受注射，81%的患者在第2个月接受注射。总体而言，40%的患者在最初3个月内BCVA提高了≥15字母数（BRVO为42%，CRVO为46%）。初始BCVA较低（<50字母）的患者比基线BCVA较高的患者改善程度更大。由于随访失访情况严重，注射次数和光学相干断层扫描（OCT）检查次数与BCVA变化无关。
德国常规临床实践中的RVO患者接受的注射次数和OCT检查次数少于临床试验中的患者。与BRVO患者相比，CRVO患者的改善程度较小且较晚。
