Save Sight Institute, Faculty of Medicine & Health, University of Sydney, Sydney, NSW, Australia.
Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, 32 Gisborne Street, East Melbourne, VIC, Australia.
Eye (Lond). 2023 Nov;37(16):3417-3422. doi: 10.1038/s41433-023-02525-9. Epub 2023 Apr 17.
We tested the hypothesis that targeted retinal laser photocoagulation (TPRP) to peripheral retinal ischaemia reduces the overall burden of aflibercept injections when treating diabetic macular oedema (DMO) over a 24-month period.
Prospective, double-masked, multicentre, randomised controlled trial in Australia comparing aflibercept monotherapy, following a treat-and-extend protocol, or combination therapy of aflibercept and TPRP for DMO. The aflibercept monotherapy group received placebo laser. The primary outcome measure was the mean number of intravitreal aflibercept injections for each group at 24 months. Secondary outcome included: mean change in central macular thickness (CMT) and vision at trial completion, the proportion of eyes whose DMO resolved and the mean injection treatment interval. Ocular and systemic adverse events were recorded.
We enrolled 48 eyes of 47 patients; 27 eyes were randomised to combination therapy (aflibercept and TPRP) and 21 to aflibercept monotherapy. Thirty-two eyes (67%) completed the 2-year study. The number of intravitreal treatments given were similar for combination therapy (10.5 (SD 5.8) and monotherapy (11.8 (SD5.6)) (P = 0.44). The mean visual improvement (+4.0 (-1.8, 9.8) and +7.8 (2.6, 12.9) letters, P = 0.32), mean decrease in CMT (-154 (-222,-87) µm and -152 (-218,-86) µm, P = 0.96), proportion of eyes with CMT < 300 µm (48% and 67%; P = 0.50) and safety outcomes were similar in both the combination and monotherapy treatment groups (respectively).
Laser to areas of ischaemic peripheral retina does not reduce the burden of intravitreal aflibercept injections when treating diabetic macular oedema.
我们通过试验来验证假设，即针对周边视网膜缺血的靶向视网膜激光光凝术（TPRP）可降低糖尿病黄斑水肿（DMO）患者在 24 个月的阿柏西普治疗过程中玻璃体内注射阿柏西普的总体负担。
本研究为前瞻性、双盲、多中心、随机对照试验，在澳大利亚开展，比较了 DMO 阿柏西普单药治疗（采用“治疗-扩展”方案）与阿柏西普联合 TPRP 治疗，前者在激光治疗时使用安慰剂。主要观察指标为两组患者在 24 个月时的玻璃体内阿柏西普注射平均次数。次要观察指标包括：试验结束时中央黄斑厚度（CMT）和视力的平均变化、DMO 消退的眼比例以及平均注射治疗间隔。记录眼部和全身不良事件。
共纳入 47 例患者的 48 只眼，其中 27 只眼随机分为联合治疗组（阿柏西普联合 TPRP），21 只眼为阿柏西普单药治疗组。32 只眼（67%）完成了 2 年的研究。联合治疗组（10.5（5.8）次）和单药治疗组（11.8（5.6）次）的玻璃体内治疗次数相似（P=0.44）。联合治疗组的平均视力改善值为+4.0（-1.8，9.8）个字母，单药治疗组为+7.8（2.6，12.9）个字母（P=0.32），平均 CMT 降低值为-154（-222，-87）μm和-152（-218，-86）μm（P=0.96），CMT<300μm 的眼比例分别为 48%和 67%（P=0.50），联合治疗组和单药治疗组的安全性结局相似。
在治疗糖尿病黄斑水肿时，激光治疗缺血性周边视网膜区域并不能减轻玻璃体内注射阿柏西普的负担。
