Kodjikian Laurent, Delcourt Cécile, Creuzot-Garcher Catherine, Massin Pascale, Conrath John, Velard Marie-Ève, Lassalle Thibaut, Pinchinat Sybil, Dupont-Benjamin Laure
La Croix-Rousse Hospital, University Hospital of Lyon, 103 Grande Rue de La Croix-Rousse, 69004, Lyon, France.
UMR CNRS 5510 MATEIS INSA Lyon, Université de Lyon Claude Bernard, Lyon, France.
Ophthalmol Ther. 2023 Jun;12(3):1671-1692. doi: 10.1007/s40123-023-00662-8. Epub 2023 Mar 26.
To evaluate real-world efficacy, safety, and treatment patterns with the dexamethasone intravitreal implant (DEX) in diabetic macular edema (DME) in France.
In this prospective, multicenter, observational, noncomparative, post-reimbursement study, consecutively enrolled patients with DME had a baseline evaluation on day 0. Those treated with DEX on day 0 were to be reevaluated at week 6 and months 6, 12, 18, and 24. DEX retreatment and/or alternative therapies were allowed during follow-up. The primary outcome measure was the maximum best corrected visual acuity (BCVA) gain from baseline during follow-up. Secondary outcome measures included time to maximum BCVA gain, patients (%) with prespecified BCVA gains from baseline at each visit, maximum central retinal thickness (CRT) reduction from baseline, patients (%) with CRT reduction ≥ 20% from baseline at each visit, patients (%) with DME resolution (per investigator judgement), and adverse events (AEs).
Of 112 patients/eyes with DME for 3.5 years (mean) at baseline, 80 (including 86.1% previously treated) received DEX on day 0 and were analyzed for efficacy. Early study termination precluded collection of ≥ 12-month efficacy data. Patients received 1.4 DEX injections over 8.3 months (averages). The maximum BCVA gain from baseline was 3.6 letters, reached after 77.2 days (averages); 24.6% (week 6) and 15.0% (month 6) of patients experienced ≥ 10-letter BCVA gains from baseline. The mean maximum CRT reduction from baseline was -146.4 µm; 61.4% (week 6) and 36.0% (month 6) of patients had CRT reductions ≥ 20% from baseline, and 68.1% reported DME resolution at least once during follow-up. Ocular hypertension (n = 8, 12.1%) was the most frequent treatment-related AE.
LOUVRE 3 confirmed that DEX improves BCVA and CRT, even in a patient population that had predominantly received DEX before enrollment in the study, and showed that DME resolution was observed during follow-up. DEX tolerability was consistent with published data, supporting treatment benefits in DME.
NCT03003416.
评估法国地塞米松玻璃体内植入物（DEX）治疗糖尿病性黄斑水肿（DME）的真实世界疗效、安全性和治疗模式。
在这项前瞻性、多中心、观察性、非对照、报销后研究中，连续纳入的DME患者在第0天进行基线评估。在第0天接受DEX治疗的患者将在第6周以及第6、12、18和24个月进行重新评估。随访期间允许进行DEX再治疗和/或替代疗法。主要结局指标是随访期间相对于基线最佳矫正视力（BCVA）的最大提高。次要结局指标包括达到最大BCVA提高的时间、每次访视时相对于基线BCVA提高达到预先设定值的患者比例（%）、相对于基线中心视网膜厚度（CRT）的最大降低值、每次访视时CRT相对于基线降低≥20%的患者比例（%）、DME消退的患者比例（根据研究者判断）以及不良事件（AE）。
在基线时患有DME平均3.5年的112例患者/眼中，80例（包括86.1%之前接受过治疗的患者）在第0天接受了DEX治疗并进行了疗效分析。早期研究终止妨碍了≥12个月疗效数据的收集。患者在8.3个月（平均）内接受了1.4次DEX注射。相对于基线BCVA的最大提高为3.6个字母，在77.2天（平均）后达到；24.6%（第6周）和15.0%（第6个月）的患者相对于基线BCVA提高≥10个字母。相对于基线CRT的平均最大降低值为-146.4 µm；61.4%（第6周）和36.0%（第6个月）的患者CRT相对于基线降低≥20%，68.1%的患者在随访期间至少有一次报告DME消退。高眼压（n = 8，12.1%）是最常见的与治疗相关的AE。
卢浮宫3研究证实，即使在入组研究前主要接受过DEX治疗的患者群体中，DEX也能改善BCVA和CRT，并表明随访期间观察到了DME消退。DEX的耐受性与已发表的数据一致，支持其对DME的治疗益处。
NCT03003416。
