NCT00490815已完成3 期
An Open Label Pharmacokinetic and Efficacy Study of 0.5 μg/Day and 0.2 μg/Day Fluocinolone Acetonide Intravitreal Inserts in Subjects With Diabetic Macular Edema
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor
研究概览
简要总结
This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema
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
- None
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
- •Age >= 18 years with diabetic macular edema
- •Diagnosis of diabetes mellitus types 1 or 2
- •Best corrected visual acuity of ≥ 19 letters
- •Retinal thickness > 250 microns by OCT
- •Investigator is comfortable deferring macular laser treatment for 6 weeks
排除标准
- •Glaucoma, ocular hypertension, IOP >21 mmHg or concurrent therapy at screening with IOP lowering agents
- •Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy
- •Prior intravitreal, subtenon, or periocular steroid therapy within the last 3 months
- •Prior intravitreal or subtenon anti-VEGF therapy within the last 2 months
- •Any ocular surgery within the last 3 months
- •Retinal laser treatment within the last 3 months
- •History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy
- •Any lens opacity which impairs visualization of the posterior pole
研究组 & 干预措施
1
Experimental
干预措施: Fluocinolone Acetonide (Drug)
2
Experimental
干预措施: Fluocinolone Acetonide (Drug)
结局指标
主要结局
Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor
时间窗: over 36 months
This was a combined assessment of the levels of fluocinolone acetonide in the plasma and aqueous humor. The average values of the data collected is entered in Outcome Data.
次要结局
- Retinal Thickness(over 36 months)
研究者
研究点 (1)
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