DEXTENZA for the Treatment of Pain and Inflammation Following Surgical Trabeculectomy and Ahmed Valve Procedures
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean change in intraocular pressure (IOP)
研究概览
简要总结
This is a prospective, comparative, open-label, single-center, randomized, investigator-sponsored clinical study and seeks to investigate clinical outcomes with standard of care and high dose DEXTENZA treatment compared to standard of care topical dexamethasone in patients undergoing trabeculectomy, trabeculectomy Ex-PRESS, Xen Gel stent, and Ahmed Valve surgery. Patients will be followed through 6 months. After screening a given patient for inclusion and exclusion criteria, and gaining informed consent, eyes of n=30 patients will be randomized to one of the following two groups (n=15per group) and followed from Baseline through Month 6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Able to provide signed written consent prior to participation in any study-related procedures
- •Patient is diagnosed with glaucoma and undergoing trabeculectomy, trabeculectomy Ex-PRESS, Xen Gel stent, or Ahmed Valve surgery
排除标准
- •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
- •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
- •Anterior chamber cells present at time of enrollment
- •Known allergy to dexamethasone or prednisolone
研究组 & 干预措施
DEXTENZA
a single intracanalicular dexamethasone (0.4 mg) insert
干预措施: DEXTENZA (Drug)
Topical Dexamethasone Treatment
Standard of care topical dexamethasone treatment through Month 2 dosing and tapering following:
6x/day week 1 4x/day weeks 2-4 2x/day weeks 5-8 Day of surgery dexamethasone ointment and patch will be applied post-surgically for overnight treatment and removed at post-operative day 1 visit in Group B eyes.
干预措施: Topical Dexamethasone (Drug)
结局指标
主要结局
Mean change in intraocular pressure (IOP)
时间窗: From baseline through month 6
mean change in intraocular pressure (IOP) from day of surgery and proportion of eyes requiring additional topical dexamethasone or anti-metabolite therapy over time
次要结局
- Mean change in best corrected visual acuity (BCVA)(From baseline through month 6)
- Mean change in Visual Field (MD)(From baseline through month 6)
- Conjunctival healing outcomes as defined by proportion of eyes requiring needling intervention associated with scar/fibrin development(From baseline through month 6)
- Proportion of eyes with absence of anterior chamber (AC) cells (score of 0) as measured by the Standardization of Uveitis Nomenclature (SUN) scale(From baseline through month 6)
- Time to resolution of anterior chamber (AC) cells and/or AC flare(From baseline through month 6)
- Number of patient call backs to medical staff regarding post-operative management of pain or medication management/dosing inquiry as documented by Electronic Health Record (E.H.R.).(From baseline through month 6)
- Incidence and severity of adverse events(From baseline through month 6)
- Proportion of eyes with absence of pain as measured by pain scale of 1-10 (pain score of 0 = absence)(From baseline through month 6)
研究者
Brian Jerkins, MD
Assistant Professor
University of Tennessee