Open-label, Single -Center, Prospective Study on the Efficacy and Safety of Intracanalicular Dexamethasone Insert 0.4mg (Dextenza) in the Treatment of Postoperative Pain and Inflammation Following Vitreo-retinal Surgery - The ADHERE Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mean cells as assessed by investigator in anterior chamber of the study eye
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of Dextenza for the treatment of postoperative pain and inflammation following vitreo-retinal surgery
详细描述
This prospective, single-center, open-label, investigator-sponsored clinical study seeks to investigate the outcomes of patients undergoing vitro-retinal surgery with the treatment of a dexamethasone intracanalicular insert. All patients in the treatment groups will receive a dexamethasone intracanalicular insert. There will be three experimental groups of patients, varying that time of insertion. Ten patients will receive the dexamethasone intracanalicular insert pre-operatively (1 week to 1 days prior to vitreo-retinal surgery). Ten patients will receive dexamethasone intracanalicular insert on the day of surgery. Ten patients will receive DEXTENZA insert Day 1 post-operatively. Ten patients will be prescribed standard of care ophthalmic drops, Prednisolone Acetate, and no dexamethasone insert (control group). All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops.
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
- Single (Outcomes Assessor)
盲法说明
Masked Sub-investigators to exam subjects at each visit after clinical evaluation for cell and/or flare.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any adult patient age 18-99 years who is planned to undergo vitreo-retinal surgery (pars plana vitrectomy with or without scleral buckle).
- •If both eyes are involved, both eyes would be eligible for the study.
- •Willing and able to comply with clinic visits and study related procedures.
- •Willing and able to sign the informed consent form.
排除标准
- •Patients under age
- •Patients who are pregnant (must be ruled out in women of child-bearing age with pregnancy test).
- •Active infectious ocular or systemic disease.
- •Patients with active infectious ocular or extraocular disease.
- •Patients actively treated with local or systemic immunosuppression
- •Use of the following anti-inflammatory or immunomodulating agents (e.g., cyclosporine) systemically, or in the study eye, for the duration of the study (excluding inhalants). Washout periods for medications prior to surgery are as follows:
- •Systemic corticosteroids - 2 weeks (see exception 5c)
- •Systemic NSAID over 375 mg per day - 2 weeks
- •Periocular/intraocular injection of any corticosteroid solution - 4 weeks (see exception 5b)
- •Corticosteroid depot/implant in the study eye - 2 months
- •Topical ocular corticosteroid - 7 days
- •Topical ocular NSAID - 7 days
- •Intraoperatively used intraocular steroid (i.e. intravitreal triamcinolone, that is used to transiently highlight the vitreous and removed during vitrectomy) is permissible in study eye.
- •Intraoperatively or perioperatively used systemic steroid for the purpose of general anesthesia (as administered by the treating anesthesiologist) is permissible.
- •Patients with systemic illness involving abnormalities of the hypothalamic-pituitary-adrenal axis; patients with primary adrenocortical insufficiency or adrenocortical hyperfunction.
- •Patients with known hypersensitivity to Dexamethasone.
- •Patients with uncontrolled glaucoma.
- •Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator.
研究组 & 干预措施
Group 1 Pre-surgery Dextenza insert
Ten patients will receive the dexamethasone intracanalicular insert pre-operatively (1 week to 1 days prior to vitreo-retinal surgery). All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops.
干预措施: Dextenza 0.4Mg Ophthalmic Insert (Drug)
Group 2 Surgery Day Dextenza insert
Ten patients will receive dexamethasone intracanalicular insert on the day of surgery. All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops.
干预措施: Dextenza 0.4Mg Ophthalmic Insert (Drug)
Group 3 Post op Day 1 Dextenza insert
Ten patients will receive DEXTENZA insert Day 1 post-operatively. All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops
干预措施: Dextenza 0.4Mg Ophthalmic Insert (Drug)
Group 4 Topical steroid
Ten patients will be prescribed standard of care ophthalmic drops, Prednisolone Acetate, and no dexamethasone insert (control group). All patients no matter what cohort will receive Gentamicin, antibiotic ophthalmic drops.
干预措施: Topical Prednisolone (Drug)
结局指标
主要结局
Mean cells as assessed by investigator in anterior chamber of the study eye
时间窗: Assessed at Day 14
As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)
Mean pain as reported by subject in the study eye: Visual Analog Scale
时间窗: Assessed at Day 28
As measured by Visual Analog Scale for Pain (VAS Pain) (0% to 100% Scale)
次要结局
- Time to absence of cells(Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56)
- Time to absence of pain(Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56)
- Proportion of rescue treatment(Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56)
- Mean anterior chamber flare(Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56)
- Assessment of Dextenza ease of insertion(Assessed at Day 1)
研究者
Patrick R. Oellers, MD
Principal Investigator
Retina Vitreous Surgeons of Central New York, PC