Multimodal Image Study of Retinal Inflammation Markers After Corticoid and Antiangiogenic Treatment in Pacients With Diabetic Macular Edema
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Coroidal thickness
研究概览
简要总结
- Main objective: Inflammation factors in imaging techniques of diabetic macular edema
- Prospective observational design
- Disease under study: Diabetic macular edema
- Methodology: Collection of the image data in the usual control (baseline visit, 4th month)
- Population under study and total number of subjects Diabetics with macular edema.
- Approximate N: 80 pacients.
- Expected duration of the study: 12 months.
详细描述
PROBLEM STATEMENT:
Background Currently the DME (diabetic macular edema) can be treated with 2 types of intravitreous treatment: corticosteroids (Ozurdex) or antiangiogenic (Eylea). Until a few years ago it was treated with photocoagulation. But the most rapid advances have been made at the level of image tests with more and more cutting-edge OCTs (optical coherence tomography) that allow an image of better quality and precision allowing more and more details to be observed. Also the new photographs of autofluorescences or the Angio-OCT allow to observe many more details. Therefore this recent field in constant progression remains unexplored. Current studies on inflammation factors before and after treatment are few and with small N that do not exceed 20.
This study aims to observe all these inflammation factors of images, anatomical involvement by DME and see how they respond after intravitreal treatment. As another more pretentious objective would be to draw some conclusion about the drugs used according to the changes observed in the images.
Justification Today, these multiple imaging techniques are the only way to obtain information about DME apart from the direct exploration of the fundus, the changes they produce and the responses to treatment. Since its appearance, the management and follow-up of patients affected by DME has been constantly improved. Given the constant evolution of the quality of the images the investigators must study the new possibilities that they offer us.
Investigation questions What are the changes in inflammatory markers that can be detected by multimodal study of new imaging techniques before and after corticosteroid and antiangiogenic treatment in patients with diabetic macular edema?
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Diagnostic of diabetic macular edema
- •Without any intravitreal treatment during the last three months
- •Patients who require intravitreal corticoid or antiangiogenic treatment following the usual clinical practice
排除标准
- •Any other macular pathology ( for exemple age-related macular degeneration)
- •Proliferative diabetic retinopathy
- •Any other eye involvement that may influence visual acuity (eg, uncontrolled glaucoma)
研究组 & 干预措施
DME treat with antiangiogenic
- 3 Intravitreal injections of 0.05 ml of Aflibercept (40 mg/ml) during 3 months (one per month) The clinical management of the patients will be adapted to the treatment standards of the Ophthalmology Service of the Hospital de la Santa Creu and Sant Pau, without the realization of this study influencing such process.
- 1 Injection of dexamethasone intravitreal implant 0.7mg. The clinical management of the patients will be adapted to the treatment standards of the Ophthalmology Service of the Hospital de la Santa Creu and Sant Pau, without the realization of this study influencing such process.
干预措施: Antiangiogenic Agents (Drug)
DME treat with antiangiogenic
- 3 Intravitreal injections of 0.05 ml of Aflibercept (40 mg/ml) during 3 months (one per month) The clinical management of the patients will be adapted to the treatment standards of the Ophthalmology Service of the Hospital de la Santa Creu and Sant Pau, without the realization of this study influencing such process.
- 1 Injection of dexamethasone intravitreal implant 0.7mg. The clinical management of the patients will be adapted to the treatment standards of the Ophthalmology Service of the Hospital de la Santa Creu and Sant Pau, without the realization of this study influencing such process.
干预措施: Corticosteroid (Drug)
结局指标
主要结局
Coroidal thickness
时间窗: At first visit and 4 months after the first intravitreal injection
Measured by OCT (EDI mode) in micrometer
Macular thickness
时间窗: At first visit and 4 months after the first intravitreal injection
Measured by OCT in micrometer
Increased macular autofluorescence
时间窗: At first visit and 4 months after the first intravitreal injection
Autofluorescence of the fundus
Numbers of hyperreflective intraretinal spots
时间窗: At first visit and 4 months after the first intravitreal injection
Measured by OCT scans
次要结局
- Best corrected visual acuity(At first visit and 4 months after the first intravitreal injection)
- Type of diabetic macular edema(At first visit and 4 months after the first intravitreal injection)
- Presence of epiretinal membrane(At first visit and 4 months after the first intravitreal injection)
- Disruption of ellipsoid line and external limiting membrane(At first visit and 4 months after the first intravitreal injection)
- Disorganization of the retinal inner layers(At first visit and 4 months after the first intravitreal injection)
- Subfoveal neuroretinal detachment(At first visit and 4 months after the first intravitreal injection)