A Randomized, Placebo-Controlled Clinical Trial of Intravitreal Triamcinolone for Refractory Diabetic Macular Edema
研究概览
详细说明
Overall 80% of diabetic patients with low vision are in the nonproliferative stage and the main cause of decreased visual acuity is macular edema.
According to the early treatment diabetic retinopathy study (ETDRS), the treatment of choice for diabetic macular edema (DME) is laser therapy, which may be neither effective nor curative in some patients.There are many cases which are refractory to laser treatment or not suitable candidates for it.
Corticosteroids might have a beneficial effect on DME. They have been used with different doses and routes (periocular,intravitreal,and slow released implants) for a variety of retinal diseases.
Recently, a few prospective randomized studies, concerning the effect of intravitreal triamcinolone acetonide (IVT) on DME have been published. In their two-year results, Gillies et al. concluded that IVT improved vision and reduced macular thickness in eyes with refractory diabetic macular edema. They showed that this beneficial effect persisted for up to 2 years with repeated treatment.
We also conducted a randomized placebo-controlled clinical trial to determine the safety and efficacy of IVT for intractable DME. Besides, we tried to evaluate the effect of this intervention on angiographic findings of these patients.
研究类型
注册
阶段
- 阶段2
联系人和位置
学习地点
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Tehran、伊朗伊斯兰共和国、16666
- Labbafinejad Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Clinically significant macular edema(CSME)
- Clinically significant macular edema(CSME)refractory to initial or supplemental macular photocoagulation
Exclusion Criteria:
- Mono-ocular patients
- History of vitrectomy
- Glaucoma or ocular hypertension
- Significant media opacity
- Traction on the macula
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
研究衡量的是什么?
主要结果指标
结果测量 |
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黄斑中心厚度
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次要结果测量
结果测量 |
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视力
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眼压
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白内障进展
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Cystoid macular edema
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Macular hard exudates
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Macular leakage severity in FA
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合作者和调查者
调查人员
- 首席研究员:Mohammad - Hossein Dehghan, MD、Ophthalmic Research Center of Shaheed Beheshti Medical University
研究记录日期
研究主要日期
学习开始
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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曲安奈德的临床试验
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Johns Hopkins University撤销
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Johns Hopkins UniversityAlimera Sciences; pSiVida Limited完全的
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Alimera SciencesCBCC Global Research招聘中
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Centre Hospitalier Universitaire Dijon招聘中