CTRI/2018/05/013869招募中4 期
Macular Edema Nepafenac vs. Difluprednate (MEND) Uveitis Trial
Proctor Foundation2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2018年5月6日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Assessment of Central Subfield Thickness on OCT
研究概览
简要总结
A study demonstrating that topical treatments are effective and safe would greatly impact practice patterns and treatment of macular edema secondary to uveitis.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Key Inclusion criteria:
- •â‰¥18 years of age
- •Diagnosis of anterior, intermediate, posterior, or panuveitis (can be infectious or non-infectious)
- •Inactive or minimally active inflammation according to Standardization of Uveitis Nomenclature
- •If on oral corticosteroids, a stable dose of <10 mg prednisone/day for >4 weeks
- •If on systemic corticosteroid-sparing immunomodulatory therapy, a stable dose for >4 weeks
- •If using prednisolone acetate 1% drops, stable regimen of ≤2 drops per day for >4 weeks
- •If infectious uveitis, inflammation must be inactive or minimally active per definition above and on stable dose of treatment for ≥4 weeks with no anticipated changes to treatment during the trial Eye-level Inclusion Criteria:
- •ME defined as thickening of the 1mm central subfield of the macula greater than 2 standard deviations above normal thickness (>320 µm by Heidelberg spectral-domain OCT)
- •Baseline intraocular pressure >5 mmHg and <21 mmHg
- •Media clarity and pupillary dilation sufficient to allow OCT testing and retinal photography
- •Best-corrected visual acuity of 5/200 or better.
排除标准
- •Key Exclusion Criteria:
- •Use of oral acetazolamide or other systemic carbonic anhydrase inhibitors at baseline
- •Known allergy or hypersensitivity to any component of the study drugs
- •History of central serous chorioretinopathy in either eye
- •Intravitreal or periocular corticosteroid injection in the past 8 weeks, dexamethasone implant in the past 12 months, or a fluocinolone acetonide implant in the past 3 years
- •Presence of an epiretinal membrane—noted clinically or by OCT—in the study eye, thought to be significant enough to preclude improvement of ME
- •Previous pars plana vitrectomy
- •History of severe glaucoma (C/D ratio > 0.9 or any notching of optic nerve to rim) 8.
结局指标
主要结局
Assessment of Central Subfield Thickness on OCT
时间窗: 4 weeks
次要结局
- 1. Proportion of patients achieving resolution, improvement, and recurrence of Macular edema by the Week 4 visit and by the Week 24 visit(2. BCVA at week 4)
研究者
研究点 (2)
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