NCT00135655撤回2 期
A Randomized, Double-Masked, Parallel, Group, Multi-Center, Dose Ranging Pilot Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- safety
研究概览
简要总结
The purpose of this study is to investigate the safety and tolerability of three dose strengths of the study drug in subjects with post cataract extraction 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
- Double
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
- •Have persistent post cataract extraction macular edema whose condition is stable
- •Have no change in medication regimen of immunosuppressive or anti-inflammatory agents; steroidal or non-steroidal agents for a specified period of time prior to randomization
- •Have at least one eligible eye to be treated in the study
- •Have an optical coherence tomography (OCT) scan with a qualifying retinal thickness in the study eye
- •Have macular edema confirmed by fluorescein angiography
排除标准
- •Have proliferative vitreoretinopathy greater than grade B in either eye
- •Have ocular disorders in the study eye that may confound interpretation of study results
- •Have ophthalmic disorders in the study eye that may influence final visual acuity and/or fluorescein angiography interpretation
- •Have had cataract surgery in the study eye in the past 2 months, YAG laser capsulotomy within the past 1 month, or any other intraocular surgery within the past 90 days
- •Have uncontrollable elevated intraocular pressure (IOP) or advanced glaucoma
- •Have had any periocular or intravitreal injection of corticosteroids in the study eye within 3 months
- •Have had any ocular implant device for the delivery of therapeutic agents
- •Be taking any excluded medications that could obscure or confound study results
结局指标
主要结局
safety
tolerability
retinal thickness
visual acuity
次要结局
未报告次要终点
研究者
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