NCT01304706已完成3 期
Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study
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
- 120
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
This study will assess the safety and utility of the new inserter for the administration of ILUVIEN in subjects with diabetic macular edema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who previously participated in the FAME studies and subjects with chronic DME considered insufficiently responsive to available therapies.
- •In the judgment of the Investigator, the subject will benefit from treatment with ILUVIEN.
- •Ability and willingness to comply with the treatment and follow up procedures.
- •Ability to understand and sign the Informed Consent Form. No expectation that subject will be moving out of the area of the clinical center to an area not covered by another clinical center during the next 12 months.
排除标准
- •Pregnant, lactating females or females of childbearing potential (unless using reliable contraception, i.e. double barrier, surgical sterilization, oral contraceptives, Norplant, intrauterine device (IUD)
- •Glaucoma, defined as glaucomatous anatomical changes of the optic disc and/or visual field changes at screening in the study eye
- •Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy (e.g., presumed ocular histoplasmosis, high myopia (spherical equivalent > 8 diopters), macular degeneration)
- •Any active viral, fungal or bacterial disease of the cornea or conjunctiva or any history of a potentially recurrent infection which could be activated by treatment with a steroid, (e.g., ocular herpes simplex virus)
- •Known or suspected hypersensitivity to any of the ingredients of the investigational product or to other corticosteroids
- •History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy or IOP-lowering procedure
- •History or presence of any disease or condition (malignancy) that in the investigator's opinion would preclude study treatment or follow-up
- •Any lens opacity which significantly impairs vision, in the opinion of the investigator.
- •Peripheral retinal detachment in prospective area of insertion
- •Participation in another clinical trial within 12 weeks before the screening visit or during the study
研究组 & 干预措施
Fluocinolone Acetonide
Experimental
干预措施: Fluocinolone Acetonide (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 12 months
This is a measurement of the number of subjects who experienced an adverse event and/or a serious adverse event during the trial.
次要结局
未报告次要终点
研究者
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