微创新庄玻璃体切除术联合内界膜剥除与抗 VEGF 玻璃体注射治疗初治糖尿病黄斑水肿（VVV-DME 研究）：一项随机对照试验的研究方案。
Microinvasive pars plana vitrectomy combined with internal limiting membrane peeling versus anti-VEGF intravitreal injection for treatment-naïve diabetic macular edema (VVV-DME study): study protocol for a randomized controlled trial.
机构信息
Tianjin Key Laboratory of Retinal Functions and Diseases, Tianjin Branch of National Clinical Research Center for Ocular Disease, Eye Institute and School of Optometry, Tianjin Medical University Eye Hospital, Tianjin, 300384, China.
出版信息
Trials. 2023 Oct 24;24(1):685. doi: 10.1186/s13063-023-07735-w.
BACKGROUND
Diabetic macular edema (DME) is the main cause of vision loss in diabetic patients. Currently, anti-vascular endothelial growth factor (VEGF) intravitreal injection stands as the first-line therapy for DME. However, some patients exhibit insufficient response to anti-VEGF agents and often require multiple injections, imposing psychological and economic burdens. While microinvasive pars plana vitrectomy (PPV) has been shown to be safe and effective in treating refractory DME, scant research has explored its application to treatment-naïve DME. The purpose of this study is to determine whether early PPV combined with internal limiting membrane (ILM) peeling can lessen the therapeutic burden of DME patients, prevent vision loss, and maintain long-term stabilization of diabetic retinopathy.
METHODS
This is a single-center, prospective, parallel-group, non-inferiority randomized controlled trial involving 102 DME participants. Participants will be randomly assigned to either the study group (PPV combined with ILM peeling) or the control group (conbercept intravitreal injection (IVC)) at a 1:1 ratio, with a scheduled follow-up at 12 months post-operation. Comparative analysis of results between the two groups will be conducted at months 1, 3, 6, and 12 after the intervention. The primary outcomes involve evaluating the changes in central subfield thickness (CST) and best corrected visual acuity (BCVA). The secondary outcomes include assessment of optical coherence tomography (OCT) and OCT angiography (OCTA) biomarkers, re-treatment and adverse events rates, diabetic retinopathy (DR) development, cost-effectiveness analysis, and vision-related quality of life (VRQL).
DISCUSSION
Some patients do not respond well to anti-VEGF drugs and repeated intravitreal injections increase the treatment burden for patients. The VVV study aims to explore whether PPV combined with ILM peeling could become an initial treatment option for treatment-naïve DME patients.
TRIAL REGISTRATION
ClinicalTrials.gov NCT05728476. Registered on 15 February 2023.
背景
糖尿病性黄斑水肿（DME）是糖尿病患者视力丧失的主要原因。目前，抗血管内皮生长因子（VEGF）玻璃体腔内注射是 DME 的一线治疗方法。然而，一些患者对抗 VEGF 药物反应不足，往往需要多次注射，这给患者带来了心理和经济负担。虽然微创经睫状体平坦部玻璃体切除术（PPV）已被证明在治疗难治性 DME 中是安全有效的，但很少有研究探讨其在未经治疗的 DME 中的应用。本研究旨在确定早期 PPV 联合内界膜（ILM）剥除是否可以减轻 DME 患者的治疗负担，防止视力丧失，并保持糖尿病性视网膜病变的长期稳定。
方法
这是一项单中心、前瞻性、平行组、非劣效性随机对照临床试验，纳入了 102 名 DME 患者。患者将按照 1:1 的比例随机分配到观察组（PPV 联合 ILM 剥除）或对照组（康柏西普玻璃体内注射（IVC）），术后 12 个月进行随访。将对两组在干预后 1、3、6 和 12 个月的结果进行比较分析。主要结局是评估中央视网膜厚度（CST）和最佳矫正视力（BCVA）的变化。次要结局包括评估光学相干断层扫描（OCT）和 OCT 血管造影（OCTA）生物标志物、再治疗和不良事件发生率、糖尿病性视网膜病变（DR）的发展、成本效益分析和视力相关生活质量（VRQL）。
讨论
一些患者对抗 VEGF 药物反应不佳，反复玻璃体腔内注射增加了患者的治疗负担。VVV 研究旨在探讨 PPV 联合 ILM 剥除是否可成为未经治疗的 DME 患者的初始治疗选择。
试验注册
ClinicalTrials.gov NCT05728476。注册于 2023 年 2 月 15 日。
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