Micropulsed Laser in Association With Intravitreal Injections of Anti-VEGF for the Treatment of Macular Edema in Diabetic Patients (LAMED).
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Number of intra-vitreal anti-VEGF injections
研究概览
简要总结
Diabetes is a major cause of blindness in adults in the developed countries. The retinal damages associated with diabetes lead to gradual loss of vision, which is accentuated when the macula is affected. This results in macular edema.
Currently, intravitreal injections of anti-VEGF have demonstrated their effectiveness and are the first line treatment of macular edema.
Subthreshold micropulsed laser photocoagulation is an alternative to conventional grid photocoagulation. By delivering pulsed impacts under the thermal lesion threshold of the pigment epithelium, it would not cause the side effects of conventional photocoagulation. Micropulsed photocoagulation combined to anti-VEGF injections, could be the most effective treatment with a minimum injection number and without epithelial lesions.
The main objective of this study is to show that the subthreshold micropulsed laser photocoagulation, in association with intravitreal injections of anti-VEGF, allows to reduce the number of anti-VEGF injections during the first year of treatment.
In this randomized, double blind study, eligible patients will be randomized between a micropulsed laser photocoagulation arm and a sham micropulsed laser photocoagulation arm.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 or more
- •macular edema associated with a 1 or type 2 diabetes with a hemoglobin A1C level over 5.5% and under <13%
- •indication for a treatment with intra-vitreal injections of ranibizumab
排除标准
- •treatment with anti-VEGF during the previous 2 months
- •treatment by intra-vitreous implant of dexamethasone during the previous six months
- •previous history of vitrectomy or glaucoma
- •photocoagulation during the previous 3 months
- •patient's opposition to participate to the study
研究组 & 干预措施
Micropulsed laser photocoagulation
干预措施: Micropulsed laser photocoagulation (Radiation)
Sham micropulsed laser photocoagulation
干预措施: Micropulsed laser photocoagulation (Radiation)
结局指标
主要结局
Number of intra-vitreal anti-VEGF injections
时间窗: One year
次要结局
- Time to reduction of the macular thickness(One year)