Evaluation of DEXTENZA on the Management of Pain and Inflammation in Patients With Anterior Uveitis Compared to Standard of Care Topical Corticosteroids
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 主要终点
- Response of Anterior Uveitis to Treatment
研究概览
简要总结
This a prospective study review of the clinical efficacy of DEXTENZA for the treatment of anterior uveitis compared to the standard of care topical corticosteroid treatment
详细描述
Patients with anterior uveitis are typically treated aggressively with every 1-2 hour (while the patient is awake) potent topical steroid agents, during initial stage of inflammation, and evaluated at frequent intervals, with a schedule of steroid tapering dictated by clinical response. The most common topical corticosteroid prescribed for the treatment of anterior uveitis are prednisolone acetate 1%, dexamethasone 0.1%, prednisolone sodium phosphate 1% and Difluprednate 0.05%. However, topical treatments are limited by the potential for patient non-adherence and variation in drug concentrations due to the intermittent or suspension of use nature of application. A corticosteroid insert placed in the inferior and superior canaliculi provides the advantages of reliable and continuous drug delivery for 24 hours a day for 30 days without the need for patients to adhere to a treatment regimen. Dextenza is a sustained-release dexamethasone intracanalicular insert recently approved by the FDA for pain and inflammation post ophthalmic surgery. Dextenza was shown to decrease inflammation and pain compared with placebo following cataract surgery in a multicenter randomized clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years old
- •Active non-infectious anterior uveitis
- •Able to provide signed written consent prior to participation in any study-related procedures.
排除标准
- •Have active intermediate, posterior uveitis, or panuveitis
- •Have infectious anterior uveitis
- •Have used topical corticosteroid treatment up to 48 hours prior to the baseline visit
- •Have used oral corticosteroid within the past 14 days prior to baseline visit (Patients using stable doses of inhaled corticosteroids for 30 days prior to baseline visit can be included in the study)
- •Have received intravitreal or sub-Tenon corticosteroid treatment prior to baseline visit or Ozurdex ® in the study eye within the 6 months prior to the baseline visit
- •Are currently using prescribed nonsteroidal anti-inflammatory agents or prescribed immunosuppressive agents, unless the dose has been stable for the last 6 weeks and no change in dosing is anticipated for the duration of the study
- •Have severe/serious ocular pathology or medical condition which may preclude study completion
- •Dacriocystitis
- •Are pregnant or lactating female, or female of childbearing age using inadequate birth control method
- •Have participated in another investigational device or drug study within 30 days of the baseline visit
研究组 & 干预措施
Topical Pred Forte 1%
Topical corticosteroid (Pred Forte, prednisolone acetate 1%) standard of care tapered treatment regimen of
8x/day week 1 4x/day week 2 2x/day week 3
1x/day week 4
Visit schedule: Baseline, Day 3, Day 7, Day 14, and Day 30
干预措施: Topical Prednisolone Acetate 1% (Drug)
Dextenza
Sustained Released 0.4 mg Dexamethasone intracanalicular insert in both upper and lower punctum.
Visit schedule: Baseline, Day 3, Day 7, Day 14, and Day 30
干预措施: Dextenza Dexamethasone Implant (Device)
结局指标
主要结局
Response of Anterior Uveitis to Treatment
时间窗: 30 days
Proportion of Subjects with Anterior Chamber Cell Grade of 0 from baseline at days 3, 7, 14, and 30
次要结局
- Improve 2 grade levels by SUN grading system(30 days)
- Mean change in cells(30 days)
- Time to zero inflammation(30 days)
- OCT(30 days)
- CME(30 days)
- Mean change in flare(30 days)
- Proportion of resolution of CME(30 days)
- IOP(30 days)
- Rescue therapy(30 days)
- Adverse events(30 days)
- Mean change in Visual Acuity(30 days)
- NEI-VQ-25(30 days)
研究者
John Huang, MD
Ophthalmologist and Clinical Associate Professor
New England Retina Associates