NCT00344968已完成3 期
A Randomized, Double-Masked, Parallel Group, Multi-center, Dose-Finding Comparison of the Safety and Efficacy of ASI-001A 0.5 μg/Day and ASI-001B 0.2 μg/Day Fluocinolone Acetonide Intravitreal Inserts to Sham Injection 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
- 956
- 主要终点
- Visual Acuity
研究概览
简要总结
This study will evaluate the 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
- Triple (Participant, 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
- 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 19-68 letters
- •Retinal thickness > 250 micron 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 6 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)
3
Sham Comparator
干预措施: Standard of care laser photocoagulation (Procedure)
结局指标
主要结局
Visual Acuity
时间窗: 36 months
The percentage of subjects with an increase from baseline of 15 or more letters in best corrected visual acuity letter score as assessed by ETDRS eye chart (study eye).
次要结局
- Retinal Thickness(36 months)
研究者
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