A Randomized, Pilot Study of the Efficacy and Safety of Ozurdex Steroid Implants in Post-Vitrectomized Eyes in Patients With Diabetic Macular Edema
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Lahey Clinic
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Visual Acuity Gain
研究概览
简要总结
Currently medications injected intravitreally in previously vitrectomized eyes have a very short half-life due to enhanced clearance of the drug. The use of the Ozurdex (dexamethasone) implant may allow sustained levels of steroid delivery to patients with diabetic macular edema that have undergone prior vitrectomy. The sustained steroid levels may lead to improved central retinal thickness measurements and improved visual acuity.
详细描述
A total of 15 patients will be enrolled into the study. This is a 3 year randomized controlled study with the primary endpoint at 1 year. Secondary safety and efficacy endpoints will be evaluated in year 2 and year 3.
Patients will be randomly enrolled into 1 of 3 groups:
Group 1: Dexamethasone administered up to every 3 months Group 2: Dexamethasone administered up to every 6 months Group 3: Sham
Patients will be evaluated on a monthly basis with ETDRS visual acuity, intraocular pressure, fundus examination and OCT.
Ozurdex (dexamethasone) or Sham Procedure will be performed on Day 0. All patients will be evaluated monthly thereafter. One month following initial injection/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adults> 18 years of age with type 1 or 2 diabetes mellitus
- •Patients with DME secondary to diabetes mellitus involving the center of the macula OCT thickness is > 300 microns with intraretinal cystic edema
- •BCVA between 20/40 to 20/400
- •Patient had vitrectomy surgery.
- •Provide a signed informed consent prior to any study procedure
排除标准
- •Patient unlikely to benefit from intravitreal Ozurdex due to macular ischemia, atrophy, or other condition
- •Patient with history of steroid response with IOP >35 mm Hg or requirement to be on > 2 glaucoma medications following previous steroid injection.
- •Previous injection of anti-VEGF or steroid in the study eye within 90 days
- •Vitrectomy, cataract surgery, or YAG capsulotomy within 90 days.
- •Current tractional detachment of the macula or vitreous hemorrhage obscuring details of the macula.
- •Pregnant, lactating females, or females of child-bearing potential that are not using reliable contraception.
研究组 & 干预措施
Dexamethasone implant up to every 3 Mo.
Ozurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter.
Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit.
Re-implantation of Ozurdex (dexamethasone) may occur at any time > 3 months following last injection in group 1 if any of the following conditions are met:
- Increase of > 50 microns from the best previous CRT measurement
- Recurrence of intraretinal cystic edema
- Persistent intraretinal cystic edema
干预措施: Dexamethasone (Drug)
Dexamethasone implant up to every 6 Mo.
Ozurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter.
Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit.
Re-implantation of Ozurdex (dexamethasone) may occur at any time >6 months following last injection in group 2 if any of the following conditions are met:
- Increase of > 50 microns from the best previous CRT measurement
- Recurrence of intraretinal cystic edema
- Persistent intraretinal cystic edema
干预措施: Dexamethasone (Drug)
Sham Implant
Sham Procedure will be performed on Day 0. All patients will be evaluated monthly thereafter.
Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. Also, at 13 months, patients in the sham group will be eligible for Ozurdex (dexamethasone) 0.7 mg implantation if initial inclusion/exclusion criteria are met. These patients would follow re-implantation guidelines of group 2.
Sham implantation may occur at any time > 6 months following last sham injection in group 3 if any of the following conditions are met:
- Increase of > 50 microns from the best previous CRT measurement
- Recurrence of intraretinal cystic edema
- Persistent intraretinal cystic edema
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Visual Acuity Gain
时间窗: 13 months
Measured visual acuity gain in number of letters improved as a result of treatment
次要结局
- Comparison of Efficacy Between Group 1 and 2(3 years)
- Visual Acuity Gain at Year 2 and 3(3 years)
- Central Retinal Thickness Reduction(1 year)
- Time to Reimplantation of Ozurdex Implant(3 years)
研究者
Jeffrey L. Marx, MD
Principal Investigator
Lahey Clinic