EUCTR2006-001035-22-IT进行中（未招募）不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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
- •?BCVA of ≥19 and ≤68 letters in the study eye by an ETDRS chart.
- •?BCVA of the non-study eye must be no worse than 20/400
- •?Diagnosis of diabetes mellitus (type 1 or type 2):
- •oUse of insulin for the treatment of diabetes for at least the 3 months prior to screening
- •oUse of oral ant hyperglycemia agents for the treatment of diabetes for at least the 3 months prior to screening
- •?DME based on investigator's clinical evaluation and demonstrated on funds photographs, fluorescein angiograms, and optical coherence tomography (OCT)
- •?Mean foveal thickness of at least 250 µm by OCT
- •?Ability and willingness to comply with the treatment and follow up procedures
- •?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: 0
- •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, intrauterine device (IUD)
- •?Laser treatment for DME 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 (e.g., triamcinolone) 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 (IOP) > 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 (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 vitrectomy in the 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 prospective area of insertion
- •?Participation in another clinical trial within 12 weeks before the screening visit or during the study
- •?Resting Systolic blood pressure at the screening visit of greater than 180 or diastolic blood pressure greater than 105.
研究者
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