Efficacy and Safety of Intravitreal Injection of Bevacizumab with and Without Oral Curcumin in Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- central macular thickness (CMT)
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of adding curcumin oral treatment to bevacizumab intravitreal injection in patients with central macular edema.
A blind study and a randomized and controlled clinical trial are conducted on diabetic patients with macular edema. The patients are divided into two intervention groups (bevacizumab + curcumin) and control (bevacizumab + placebo).
The evaluation of the central thickness of the macula and the evaluation of the central volume of the macula are the primary goals and the evaluation of the best visual acuity of the patient is the secondary goal.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with center-involving macular edema with macular center thickness more than 300 microns in OCT 2-Patients who did not receive intravitreal bevacizumab in the last 3 months and intravitreal corticosteroids in the last 6 months.
- •3- The amount of BCVA should not be <20/
- •4-Consent to participate in the study
排除标准
- •Other retinal diseases except for DME and macular edema due to other causes including uveitis, epiretinal membrane, central retinal vein occlusion, and...
- •Existence of proliferative diabetic retinopathy and patients with a history of vitrectomy
- •Patients with glaucoma, vitreous hemorrhage, age-related macular degeneration (ARMD)
- •Media opacities that limit the interpretation of diagnostic tests
- •Surgery or procedure 3 months before starting treatment
- •Pregnancy or breastfeeding
- •History of allergy to curcumin
- •Use of warfarin
- •Changing the patient's clinical diagnosis or the need for surgical interventions in the course of the disease
- •Change in the patient's general health condition
- •Absence of patient referrals
- •Lack of consent to continue treatment and follow-up
结局指标
主要结局
central macular thickness (CMT)
时间窗: 3 months
Changes in central macular thickness (CMT) in patients with oral Curcumin versus patients in the control group
central macular volume (CMV)
时间窗: 3 months
Changes in central macular volume (CMV) in patients with oral Curcumin versus patients in the control group
次要结局
- best visual acuity (BCVA)(3 months)
研究者
Mohsen Pourazizi
Dr.Mohsen Pourazizi
Isfahan University of Medical Sciences