EUCTR2006-001035-22-PT进行中（未招募）1 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 - FAME
Alimera Science Inc0 个研究点目标入组 900 人开始时间: 2006年5月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Males and non-pregnant females at least 18 years of age, Best corrected visual acuity (BCVA) of >19 and <68 letters by ETDRS in the study eye. BCVA of the non-study eye must be no worse than 20/400, Diagnosis of diabetes mellitus (type 1 or type 2), At least one macular laser treatment > 12 weeks prior to screening visit, Diabetic macular edema based on investigator’s clinical evaluation and demonstrated on fundus photographs, fluorescein angiograms, and OCT despite previous laser , Mean foveal thickness of at least 250 µm by OCT, Ability and willingness to comply with treatment and follow up process, Ability to understand and sign the Informed Consent Form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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, IUD), Laser treatment for diabetic macular edema within 12 weeks of screening or judged to be necessary within 6 weeks following enrollment , Any ocular surgery in the study eye within 12 weeks of screening, Yag capsulotomy in the study eye within 15 days of screening, Prior intravitreal, subtenon, or periocular steroid therapy within 6 months prior to enrollment (i.e. triamcinolone injection), Any change in systemic steroidal therapy within 3 months of screening, Glaucoma, ocular hypertension, intraocular pressure > 21 mmHg or concurrent therapy at screening with IOP-lowering agents in the study eye, Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy (i.e. presumed ocular histoplasmosis, high myopia (spherical equivalent > 8 diopters), macular degeneration), Any viral disease of the cornea or conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, any mycobacterial infections of the eye, any fungal disease of any ocular structure, or history of infectious retinitis, Known or suspected hypersensitivity to any of the ingredients of the investigational product or to other corticosteroids , History of vitrectomy in study eye , History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy, 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 impairs visualization of the posterior pole, Peripheral retinal detachment in area of insertion, Participation in another clinical treatment trial within 12 weeks of screening or during the study
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