Rousseau Nicolas, Lebreton Olivier, Masse Hélène, Maucourant Yann, Pipelart Valentin, Clement Manon, Le Lez Marie-Laure, Khanna Raoul Kanav, Pepin Maxime, Eude Yannick, Le Meur Guylène, Weber Michel, Ducloyer Jean-Baptiste
Nantes Université, CHU Nantes, Service d'ophtalmologie, 1 Place Alexis Ricordeau, 44093, Nantes, France.
Centre Hospitalier Universitaire de Rennes, Service d'ophtalmologie, Rennes, France.
Ophthalmol Ther. 2023 Oct;12(5):2781-2792. doi: 10.1007/s40123-023-00749-2. Epub 2023 Jun 27.
The aim of this study was to assess the efficacy and safety of fluocinolone acetonide implant (FAci) injected 1 month after the last dexamethasone intravitreal implant (DEXi) in chronic diabetic macular oedema (DME) patients.
Retrospective multicentric study conducted in pseudophakic patients with chronic DME frequently treated with dexamethasone intravitreal implant (DEXi; time to DME recurrence ≤ 6 months), receiving FAci 1 month after the last DEXi, with at least a 6-month follow-up. Best-corrected visual acuity (BCVA), central macular thickness (CMT) on optical coherence tomography, intraocular pressure (IOP) and additional treatments were assessed on the day of FAci injection (M0), 1 (M1) and 3 months (M3) later and then every 3 months.
A total of 41 eyes from 34 patients were included. At M0, patients' mean age was 68.7 ± 9.8 years, the mean DME duration was 63.9 ± 22.9 months, the mean interval between two DEXi was 14.2 ± 3.3 weeks. M12 data were available for 71% of patients. At baseline, the mean BCVA, CMT and IOP were 63.2 ± 16.6 letters, 299.4 ± 103.3 µm, and 16.2 ± 4.5 mmHg, respectively, and remained stable during the follow-up. At M12, 14% of patients required additional intravitreal treatments.
In pseudophakic patients with chronic DME showing good response to DEXi but requiring repeated injections every < 6 months, switching to FAci 1 month after the last DEXi was effective and safe. Further prospective randomized controlled studies are needed to confirm these findings, and to determine the best interval between the last DEXi and the first FAci.
本研究旨在评估在慢性糖尿病性黄斑水肿（DME）患者中，于最后一次玻璃体内注射地塞米松植入物（DEXi）1个月后注射醋酸氟轻松植入物（FAci）的疗效和安全性。
对经常接受玻璃体内注射地塞米松植入物（DEXi；DME复发时间≤6个月）治疗的假晶状体慢性DME患者进行回顾性多中心研究，在最后一次DEXi注射1个月后接受FAci治疗，并进行至少6个月的随访。在FAci注射当天（M0）、1个月后（M1）和3个月后（M3），然后每3个月评估最佳矫正视力（BCVA）、光学相干断层扫描上的中心黄斑厚度（CMT）、眼压（IOP）和额外治疗情况。
共纳入34例患者的41只眼。在M0时，患者的平均年龄为68.7±9.8岁，平均DME病程为63.9±22.9个月，两次DEXi之间的平均间隔为14.2±3.3周。71%的患者有M12的数据。基线时，平均BCVA、CMT和IOP分别为63.2±16.6字母、299.4±103.3µm和16.2±4.5mmHg，且在随访期间保持稳定。在M12时，14%的患者需要额外的玻璃体内治疗。
对于对DEXi反应良好但需要每<6个月重复注射的假晶状体慢性DME患者，在最后一次DEXi注射1个月后改用FAci是有效且安全的。需要进一步的前瞻性随机对照研究来证实这些发现，并确定最后一次DEXi与首次FAci之间的最佳间隔。
