Sub-macular Injection of Ranibizumab as a New Surgical Treatment for Refractory Diabetic Macular Edema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- The primary endpoint for this study was the change in CMT at the final visit.
研究概览
简要总结
The best treatment strategy for refractory DME is not known, options include switching between anti-VEGF agents, corticosteroids, and vitrectomy. In this study, authors describe a new surgical technique for the treatment of refractory non tractional DME. The technique consists of vitrectomy with ILM peeling with subretinal injection of Ranibizumab.
详细描述
Purpose: In this study, authors describe a new surgical technique for the treatment of refractory DME. The technique consists of vitrectomy with ILM peeling with subretinal injection of Ranibizumab.
Methods: This is a prospective interventional non-comparative study including patients with refractory DME. Included patients were subjected to the new surgical technique of pars plana vitrectomy with sub-retinal injection of Ranibizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •refractory diffuse non tractional DME.
- •Central retinal thickness (CRT) should exceed 350 µm despite undergoing multiple anti-VEGF therapy.
- •Decimal best corrected visual acuity (BCVA) must be ≥0.01 and ≤0.5.
排除标准
- •Previous vitrectomy, recent cataract surgery less than 6 months,
- •evident RPE atrophy, proliferative diabetic retinopathy, massive foveal hard exudation, foveal traction on OCT,
- •glaucoma and one eyed patients.
研究组 & 干预措施
Persistent Diabetic macular edema
Authors defined refractory DME as eyes with persistent DME despite receiving at least 6 monthly Ranibizumab injections of anti VEGF, and then switched to Aflibercept, receiving at least three monthly injections.
干预措施: Sub-macular injection of Ranibizumab (Procedure)
结局指标
主要结局
The primary endpoint for this study was the change in CMT at the final visit.
时间窗: at the 6 month follow up visit
Central macular thickness
次要结局
未报告次要终点
研究者
Mahmoud Abouhussein
Assistant professor
University of Alexandria