Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) When Placed Within the Lower Eye Lid Canaliculus or Both the Upper and Lower Canaliculi for the Treatment of Pain, Inflammation, and Cystoid Macular Edema Following 27 Gauge Vitrectomy With Internal Limiting Membrane Peel for the Treatment of Retinal Edema Associated With Macular Pucker.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean change in retina edema
研究概览
简要总结
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel
详细描述
Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts, when placed within the lower eye lid canaliculus or both the upper and lower canaliculi for the treatment of pain, inflammation, and cystoid macular edema following 27 gauge vitrectomy with internal limiting membrane peel for the treatment of retinal edema associated with macular pucker
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
- 否
入选标准
- •A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
- •Symptomatic macular pucker with retinal edema
- •Age 18 years and older
- •Scheduled vitrectomy and internal limiting membrane peel
- •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
- •A patient who meets any of the following criteria will be excluded from the study:
- •Patients under the age of 18
- •Pregnancy ( must be ruled out in women of child-bearing age with pregnancy test)
- •Active infectious systemic disease
- •Active infectious ocular or extraocular disease
- •Obstructed nasolacrimal duct in the study eye (s)
- •Hypersensitivity to dexamethasone or prednisolone eye drops
- •Patients being treated with immunomodulating agents in the study eye(s)
- •Patient being treated with immunosuppressants and/or oral steroids
- •Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
研究组 & 干预措施
DEXTENZA Group
Patients undergoing vitrectomy with internal limiting membrane peel
干预措施: Dexamethasone Intracanalicular Insert, 0.4 mg (Drug)
Second DEXTENZA Group
Patients undergoing vitrectomy with internal limiting membrane peel
干预措施: Dexamethasone Intracanalicular Insert, 0.4 mg (Drug)
Topical Prednisolone Acetate 1% Group
Patients undergoing vitrectomy with internal limiting membrane peel
干预措施: Prednisone acetate 1% (Drug)
结局指标
主要结局
Mean change in retina edema
时间窗: assessed on day 30 and day 60
As measured by Optical Coherence Tomography (OCT)
次要结局
- Mean Change in Best- Corrected Visual Acuity (BCVA)(from baseline at days 1, 7, 30, 60)
- Physician ease of Dextenza insertion(as assessed on day of surgery)
- Mean change in Inflammation ( Cell and Flare)(as assessed on days 1, 7, 30, 60)
- Mean change in pain scores(as assessed on days 1, 7, 30, 60)