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临床试验/NCT05990829
NCT05990829招募中4 期

Compare the Efficacy of VItrectomy Combined With DExamethasone Implant Versus With Aflibercept in DME Patients Diagnosed by Intraoperative OCT (the VIDEO Study): Study Protocol for a Randomized Controlled Trial

Tianjin Medical University Eye Hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
64
试验地点
1
主要终点
Average change in central foveal thickness (CFT)

研究概览

简要总结

Diabetic macular edema (DME) is the main cause of severe vision loss in diabetic retinopathy. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) and Ozurdex are two safe and effective ways to treat DME. Pars plana vitrectomy is mainly suitable for the treatment of unabsorbed vitreous hemorrhage (VH) and tractional retinal detachment caused by proliferative diabetic retinopathy (PDR). Intraoperative optical coherence tomography (OCT), a diagnostic device, can be used to evaluate the potential condition of the retina. Many patients with PDR have unclear refractive stroma due to VH and other reasons, so preoperative OCT cannot give a clear diagnosis, so the use of intraoperative OCT can judge whether the patients are complicated with DME and give corresponding treatment. The purpose of this study is to explore the prognosis of patients with DME diagnosed by OCT during PPV and treated with PPV combined with aflibercept or PPV combined with Ozurdex, and to observe and compare the postoperative anatomical results, functional results, times of reinjections and the occurrence of adverse events between the two groups, in order to provide accurate treatment for patients, reduce the frequency of postoperative vitreous injection and lighten the burden of patients.

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

入选标准

  • ≥18 years of age;
  • Patients and their families fully understand the research and must sign an informed consent form;
  • Patients have a history of diabetes and were diagnosed with PDR by ophthalmic examination;
  • Haemoglobin A1c (HbA1c) levels of <10% within 3 months;
  • No contraindication of vitrectomy;
  • Pseudophakia or this operation is combined with phacoemulsification and lens implantation;
  • Diagnosed with DME by intraoperative optical coherence tomography during vitrectomy

排除标准

  • The follow-up period is less than 6 months;
  • Patients need gas or silicon oil tamponade;
  • Patients with rubeosis iridis, neovascular glaucoma and endophthalmitis;
  • Patients with other intraocular surgeries (except cataract surgery with no ruptured posterior lens capsule);
  • Patients with other retinal diseases (i.e., age-related macular degeneration, retinal vein occlusion);
  • Patients received intravitreal Ozurdex three months prior to screening or anti-VEGF injection one month prior to screening;
  • Patients with uncontrolled systemic disease

研究组 & 干预措施

Ozurdex group

Experimental

Standard 25-gauge pars plana vitrectomy (PPV) will be performed under retrobulbar anaesthesia using high-speed vitrectomy system. Clear all the vitreous hemorrhage and proliferative membrane during PPV operation, panretinal photocoagulation should be completed. The vitreous cavity will be filled with balanced salt solution. An injection of Ozurdex will be performed at the end of the surgery.

干预措施: Ozurdex (Drug)

Aflibercept group

Active Comparator

Standard 25-gauge pars plana vitrectomy (PPV) will be performed under retrobulbar anaesthesia using high-speed vitrectomy system. Clear all the vitreous hemorrhage and proliferative membrane during PPV operation, panretinal photocoagulation should be completed. The vitreous cavity will be filled with balanced salt solution. An injection of aflibercept will be performed at the end of the surgery.

干预措施: Aflibercept (Drug)

结局指标

主要结局

Average change in central foveal thickness (CFT)

时间窗: 1, 3, 6 month postoperatively

Three-dimensional swept source optical coherence tomography (SS-OCT)

次要结局

  • Average change in best corrected visual acuity (BCVA)(1, 3, 6 month postoperatively)
  • Number of reinjections(6 months postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bojie Hu

Professor

Tianjin Medical University Eye Hospital

研究点 (1)

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