Traditional Chinese Medicine and Ranibizumab in the Treatment of Macular Cystoid Edema Associated With Retinal Vein Obstruction.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Mean number of injections
研究概览
简要总结
The objective of this study was to investigate the efficacy and safety of traditional Chinese medicine (Jueling Mingmu Decoction) combined with ranibizumab in the treatment of macular edema with retinal vein obstructive.
详细描述
Compared to the sole intravitreal injection of ranibizumab, the combined use of traditional Chinese medicine with intravitreal ranibizumab aims to determine if it is more effective in alleviating macular cystoid edema secondary to retinal branch vein occlusion, leading to improved visual prognosis and potentially reducing the frequency of intravitreal drug injections.
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
- Double (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
- 是
入选标准
- •Foveal center-involved macular edema (ME) lasting less than 9 months
- •Central Macular Thickness (CMT) greater than or equal to 250 μm
- •Best-Corrected Visual Acuity (BCVA) of 24-73 letters (20/40 to 20/320) in the study eye
- •Initial diagnosis with no prior treatments, such as laser therapy or intravitreal injections
排除标准
- •Presence of any additional macular pathology, such as age-related macular degeneration (AMD) or diabetic retinopathy (DR) affecting the macula
- •Concurrent serious conditions, such as cardiovascular diseases, liver, or kidney diseases
- •Concerns or doubts regarding treatment
- •Known allergies to the ingredients of the medication.
研究组 & 干预措施
Combination Therapy Group
During the initial month, the patient consumed Jueling Mingmu decoction daily for one month.
Patients received monthly intravitreal injections of 0.5mg ranibizumab for the initial three months, followed by additional injections in the subsequent nine months for those who met eligibility criteria.
干预措施: Jueling Mingmu decoction (Drug)
Combination Therapy Group
During the initial month, the patient consumed Jueling Mingmu decoction daily for one month.
Patients received monthly intravitreal injections of 0.5mg ranibizumab for the initial three months, followed by additional injections in the subsequent nine months for those who met eligibility criteria.
干预措施: intravitreal injections of 0.5mg ranibizumab (Drug)
Intravitreal Ranibizumab Group
Patients received monthly intravitreal injections of 0.5mg ranibizumab for the initial three months, followed by additional injections in the subsequent nine months for those who met eligibility criteria.
干预措施: intravitreal injections of 0.5mg ranibizumab (Drug)
结局指标
主要结局
Mean number of injections
时间窗: 48 weeks
We will calculate the mean number of intravitreal ranibizumab injections at week 48.
次要结局
- Change in BCVA(48 weeks)
- The mean change of central retinal thickness (CRT).(48 weeks)
研究者
Zhou Hangshuai
doctor
Dongyang People's Hospital