Microinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Best corrected visual acuity change (BCVA)
研究概览
简要总结
Diabetic macular edema (DME) is the main cause of vision loss in patients with diabetes. At present, anti-vascular endothelial growth factor (VEGF) intravitreal injection is the first-line therapy for DME, nevertheless, some patients do not respond well to anti-VEGF agents and often require multiple injections, which increases the psychological and economic burden of patients. Microinvasive pars plana vitrectomy (PPV) has been proven to be safe and effective for refractory DME. However, there are few studies on treatment-naïve DME. The purpose of this study is to explore whether early PPV combined with internal limiting membrane (ILM) peeling can reduce the treatment burden of DME patients, prevent vision loss, and maintain long-term stabilization of diabetic retinopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Patients and their families fully understand the research and sign the informed consent form
- •Diagnosed with type 1 or 2 diabetes mellitus
- •Hemoglobin A1c (HbA1c) of less than 10% within 3 months
- •Clear media for adequate OCT and optical coherence tomography angiography (OCTA) images
- •Treatment-naïve DME diagnosed clinically
- •Central subfield thickness (CST) of >300μm and intra- or subretinal fluid seen on (spectral-domain) SD-OCT
- •Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA between 24 and 73 letters on the day of randomization
- •Treatment within 12 months of DME diagnosis
- •No contraindication of vitrectomy or conbercept intravitreal injection
排除标准
- •Any previous DME treatment (i.e. anti-VEGF injections, intraocular corticosteroids, macular photocoagulation)
- •Macular edema caused by other disease (i.e. neovascular age-related macular degeneration, retinal vein occlusion, uveitis)
- •Any previous intraocular surgeries (cataract surgery performed at least 3 months before study entry will not be exclusionary)
- •Vision loss caused by other ocular disease (i.e. cataract, proliferative diabetic retinopathy, glaucoma, high myopia)
- •A follow-up duration of less than 12 months
- •Severe dysfunction of the heart, liver, kidney, lung and other organs
研究组 & 干预措施
Vitrectomy group
Standard 25-gauge PPV will be performed by an experienced surgeon under retrobulbar anesthesia. After clearing the central vitreous, a complete posterior vitreous detachment (PVD) will be achieved with aspiration to remove the tightly attached posterior hyaloid. The vitreous will be removed by a high-speed vitrectomy surgical system (Constellation Vision System, Alcon Laboratories, Fort Worth, Texas, USA). The ILM stained with indocyanine green (ICG) will be peeled up to the vascular arcades. In case of need, panretinal photocoagulation (PRP) can be performed during surgery. The vitreous cavity will be filled with balanced salt solution (BSS) at the end of the procedure.
干预措施: Vitrectomy combined with ILM peeling (Procedure)
Anti-VEGF group
Patients will receive three monthly intravitreal injections of 0.5 mg Conbercept (Chengdu Kanghong Biotech Co.) with a 30-gauge syringe needle approximately 3.5-4 mm posterior to the corneal limbus under topical anesthesia.
干预措施: Conbercept intravitreal injection (Drug)
结局指标
主要结局
Best corrected visual acuity change (BCVA)
时间窗: 1, 3, 6, 12 month postoperatively
Early Treatment Diabetic Retinopathy Study (ETDRS) Alphabet Chart
Central subfield thickness (CST) change
时间窗: 1, 3, 6, 12 month postoperatively
Three-dimensional spectral domain optical coherence tomography (SD-OCT)
次要结局
- The stage of diabetic retinopathy (DR)(12 month postoperatively)
- Cost-effectiveness analysis(12 month postoperatively)
- Vision-related quality of life questionnaire(6, 12 month postoperatively)
- Biomarkers of optical coherence tomography (OCT)(1, 3, 6, 12 month postoperatively)
- Biomarkers of OCT angiography (OCTA)(1, 3, 6, 12 month postoperatively)
- Occurrence rates of re-treatment(12 months postoperatively)
- Occurrence rates of adverse events(12 months postoperatively)
研究者
Bojie Hu
Professor
Tianjin Medical University Eye Hospital