Zhao Xuli, Lin Zhiqing, Long Ting, Yang Guang, Zhang Junjun
Department of Ophthalmology, Chengdu Second People's Hospital, Chengdu, 610017, Sichuan, China.
Department of Ophthalmology, Chengdu AiDi Eye Hospital, Chengdu, 610000, Sichuan, China.
Int Ophthalmol. 2025 Jun 27;45(1):267. doi: 10.1007/s10792-025-03646-8.
This study evaluated the clinical effectiveness and safety of a combined dexamethasone implant (Ozurdex) with Conbercept injections for diabetic macular edema (DME).
A prospective case-control clinical trial was conducted on 46 DME patients. Patients were randomly assigned to either the combination group, receiving Conbercept injections followed by Ozurdex (24 patients) using a 2 + 1 + 1 + PRN protocol, or the monotherapy group, receiving only Conbercept injections (22 patients) following a 5 + PRN protocol. Monthly evaluations were performed at six and twelve months to compare best-corrected visual acuity (BCVA), central macular thickness (CMT), injection frequency, and safety outcomes such as endophthalmitis, cataract development, retinal detachment, and intraocular pressure elevation.
Results showed that the combination group's 12-month BCVA improvement rate was 97.05%, significantly higher than the monotherapy group's 76.47% (P < 0.05). Both groups' BCVA and CMT significantly improved from baseline at six and twelve months (P < 0.05). CMT differences were significant (P < 0.05). The combination group received an average of 5.29 injections, compared to 8.15 in the monotherapy group. In terms of safety, 17.6% of eyes in the combination group had intraocular pressures ≥ 25 mmHg, managed with observation or topical therapy. At 12 months, 17.6% and 29.4% of eyes in the two groups underwent cataract surgery, respectively, with no cases of endophthalmitis or retinal detachment.
Early combined therapy with dexamethasone implant (Ozurdex) and Conbercept injections offers significant clinical benefits for the treatment of DME during the initial three months of treatment.
本研究评估了地塞米松植入剂(Ozurdex)联合康柏西普注射治疗糖尿病性黄斑水肿(DME)的临床疗效和安全性。
对46例DME患者进行了一项前瞻性病例对照临床试验。患者被随机分为联合治疗组(24例),采用2 + 1 + 1 + PRN方案,先接受康柏西普注射,随后植入Ozurdex;或单药治疗组(22例),采用5 + PRN方案,仅接受康柏西普注射。在6个月和12个月时进行每月一次的评估,以比较最佳矫正视力(BCVA)、中心黄斑厚度(CMT)、注射频率以及安全性结果,如眼内炎、白内障进展、视网膜脱离和眼压升高。
结果显示,联合治疗组12个月时的BCVA改善率为97.05%,显著高于单药治疗组的76.47%(P < 0.05)。两组的BCVA和CMT在6个月和12个月时均较基线有显著改善(P < 0.05)。CMT差异显著(P < 0.05)。联合治疗组平均注射5.29次,而单药治疗组为8.15次。在安全性方面,联合治疗组17.6%的眼睛眼压≥25 mmHg,通过观察或局部治疗进行处理。在12个月时,两组分别有17.6%和29.4%的眼睛接受了白内障手术,未发生眼内炎或视网膜脱离病例。
地塞米松植入剂(Ozurdex)联合康柏西普早期联合治疗在治疗DME的最初三个月具有显著的临床益处。