Combination Therapy Based on Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema Treatment to Help the Antiedemigenous Effect of Intravitreal Dexamethasone in Subjects With Diabetic Macular Edema (DME)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 6
- 主要终点
- Mean difference in CRT from baseline to 6 months
研究概览
简要总结
The aim of the study is to explore the effect of a curcumin formulation in combination to intravitreal dexamethasone therapy in patients with diabetic macular edema on morphological retinal characteristics and retreatment times.
详细描述
Patients with diagnosis of clinically significant diabetic macular edema, confirmed by fluorangiography and OCT, undergoing to intravitreal dexamethazone injection will be enrolled in the study.
Enrollment will take place according to the inclusion/exclusion criteria set by the protocol.
The enrolled patients will be randomized for the addition or not of the curcumin formulation (2 tablets/die for 6 months) to intravitreal therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patients with clinically significant diabetic macular edema in non-proliferative diabetic retinopathy, diagnosed by fluorangiography and OCT
- •Naive patients
- •Patients with clinically significant DME who have not been treated for more than 3 months with anti-VEGF therapy and for more than 6 months with intravitreal injection of dexamethasone
- •Central retinal thickness (CRT) at OCT> 300 microns
- •Best Corrected Visual Acuity (BCVA) with ETDRS tables at 4 meters not <20/400
- •Ability to provide written informed consent and follow the procedures of the study
排除标准
- •Retinal pathologies other than diabetic macular edema
- •Proliferative diabetic retinopathy
- •Opacities that limit the execution and interpretation of diagnostic tests
- •Surgical interventions in the study eye in the 3 months prior to the start of treatment
- •Pregnancy
- •Feeding time
研究组 & 干预措施
dexamethazone intravitreal injection
Intervention: dexamethazone intravitreal injection (0,7 mg) in PRN for diabetic macular edema treatment monotherapy.
DIABEC plus intravitreal dexamethazone
Intervention:Curmin formulation (DIABEC) plus dexamethazone intravitreal injection. Oral curcumin formulation (DIABEC 2 tablets/die) in combination with Dexamethazone (0,7 mg) intravitral injection for diabetic macular edema treatment
干预措施: DIABEC plus intravitreal dexamethazone (Combination Product)
结局指标
主要结局
Mean difference in CRT from baseline to 6 months
时间窗: 6 months
To explore the effect of curcumin formulation in addition to intravitreal dexamethasone therapy on OCT central retinal thickness after 6 months of therapy
次要结局
- Mean difference in BCVA from baseline to 6 months(6 months)
- Retreatment times(6 months)
- Evaluation of safety: incidence of Treatment-Emergent Adverse Events(6 months)
研究者
Mariacristina Parravano
MD , Head RETINA UNIT
Fondazione G.B. Bietti, IRCCS