EUCTR2006-001035-22-GB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3月14日最近更新:
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
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); use of insulin for treatment of diabetes for at least the 3 months prior to screening: use of oral antihyperglycaemic agents for the treatment of diabetes for at least 3 months prior to screening
- •- Diabetic macular edema based on investigator’s clinical evaluation and demonstrated on fundus photographs, fluorescein angiograms, and OCT
- •- 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
- •- At least one macular laser treatment more than 12 weeks prior to the screening visit
- •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 3 months prior to enrollment (i.e. triamcinolone injection) or prior treatment with intravitreal anti-VEGF treatment within 2 months of enrollment (Lucentis, Avastin, Macugen) Systemic treatment with Avastin is also not allowed within 3 months prior to screening.
- •- 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 active viral, fungal or baterial disease of the cornea or conjunctiva or any history of a potentially recurrent infection which could be activated by treatment with a steroid, (eg. Occular herpes simplex virus)
- •- 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 or significantly impairs vision in the opinion of the investigator
- •- Peripheral retinal detachment in area of insertion
- •- Participation in another clinical treatment trial within 12 weeks of screening or during the study
- •- Resting systolic blood pressure of greater than 180 or diastolic blood pressure greater than 105 at the screening visit
研究者
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