Lions Eye Institute, Perth, Western Australia, Australia.
Lions Outback Vision, Lions Eye Institute, Broome, Werstern Australia, Australia.
Clin Exp Ophthalmol. 2022 Jul;50(5):522-533. doi: 10.1111/ceo.14079. Epub 2022 Apr 8.
Frequent intravitreal anti-VEGF injections are impractical for many Aboriginal patients with diabetic macular oedema (DMO). The longer acting intravitreal dexamethasone implant (DEX-implant) is approved for DMO but has not been assessed in an Aboriginal population.
This was a prospective, multicentre, randomised, single-masked, non-inferiority clinical trial. Aboriginal adults from Western Australia with DMO were randomised to receive 3-monthly DEX-implant, or monthly intravitreal bevacizumab. The primary outcome was the change in best corrected visual acuity (BCVA) at 12 months.
The final endpoint was analysed for 24 DEX-implant and 28 bevacizumab injection eyes. Mean BCVA improved by 4.0 letters (-0.08 LogMAR) in the DEX-implant group and worsened by 5.5 letters (0.11 LogMAR) in the bevacizumab group. Before adjusting for cataract surgery, the upper bound of the two-sided 90% CI for the DEX-implant was 3.5 letters (0.07 LogMAR), which met non-inferiority criteria. The BCVA of remote participants who received the DEX-implant improved by 5.5 letters (0.11 LogMAR), compared to an 18.5 letter (0.37 LogMAR) decline for bevacizumab (p = 0.04). The incidence of steroid-induced ocular hypertension for the DEX-implant was 33.3%.
Before adjusting for the effect of cataract surgery, the DEX-implant was non-inferior to bevacizumab for treating DMO in Aboriginal participants. In remote participants, the DEX-implant surpassed non-inferiority to achieve superior outcomes to bevacizumab. The incidence of steroid-induced hypertension was comparable to that reported in non-Aboriginal populations. We provide guidelines for the judicious use of DEX-implant among Aboriginal people, and a framework for performing ophthalmic clinical trials in Aboriginal communities.
对于许多患有糖尿病黄斑水肿（DMO）的原住民患者来说，频繁进行玻璃体内抗血管内皮生长因子（VEGF）注射是不切实际的。长效玻璃体内地塞米松植入物（DEX 植入物）已被批准用于治疗 DMO，但尚未在原住民人群中进行评估。
这是一项前瞻性、多中心、随机、单盲、非劣效性临床试验。来自西澳大利亚的患有 DMO 的原住民成年人被随机分配接受每 3 个月一次的 DEX 植入物或每月一次的玻璃体内贝伐单抗治疗。主要结局是 12 个月时最佳矫正视力（BCVA）的变化。
对 24 只 DEX 植入物和 28 只贝伐单抗注射眼进行了最终终点分析。DEX 植入物组的 BCVA 平均提高了 4.0 个字母（-0.08 LogMAR），贝伐单抗组则恶化了 5.5 个字母（0.11 LogMAR）。在未调整白内障手术的情况下，DEX 植入物的双侧 90%置信区间上限为 3.5 个字母（0.07 LogMAR），符合非劣效性标准。接受 DEX 植入物的远程参与者的 BCVA 提高了 5.5 个字母（0.11 LogMAR），而贝伐单抗组则下降了 18.5 个字母（0.37 LogMAR）（p=0.04）。DEX 植入物的类固醇诱导性眼压升高发生率为 33.3%。
在未调整白内障手术影响的情况下，DEX 植入物在治疗原住民参与者的 DMO 方面与贝伐单抗非劣效。在远程参与者中，DEX 植入物超越非劣效性，取得了优于贝伐单抗的结果。类固醇诱导性高血压的发生率与非原住民人群报告的发生率相当。我们为原住民人群中合理使用 DEX 植入物提供了指导，并为在原住民社区进行眼科临床试验提供了框架。
