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临床试验/NCT01410201
NCT01410201终止不适用

Dexamethasone Intravitreal Implant After Vitrectomy for Idiopathic Epiretinal Membrane

Barnes Retina Institute3 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
3
主要终点
Changes in best corrected visual acuity

研究概览

简要总结

The purpose of this study is to evaluate the effect of dexamethasone intravitreal implant (Ozurdex) in combination with pars plana vitrectomy and membrane peeling for idiopathic epiretinal membrane (ERM).

详细描述

Pars plana vitrectomy with membrane peeling has been used for years to successfully to treat ERM (epiretinal membrane). However, despite successful surgery, approximately 10-30% of patients may not experience any improvement in visual acuity (ref. 1-7). Macular causes of unsatisfactory visual outcome following vitrectomy include persistent macular edema and reoccurrence of epiretinal membrane (ref. 1-7). Concomitant administration of intravitreal corticosteroids (triamcinolone acetonide) after pars plana vitrectomy and membrane peeling for epiretinal membrane has been reported to speed up and improve the anatomic and functional outcome (ref 8). Given that intravitreal triamcinolone has been reported to last approximately 113 days ina post-vitrectomy eye (ref. 9); the investigators postulate that a longer-acting corticosteroid such as Ozurdex could not only have the benefits of improved anatomic and functional outcomes, but also a longer sustained effect.

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

性别
All
接受健康志愿者

入选标准

  • Patients with idiopathic epiretinal membrane
  • Preoperative visual acuity of snellen equivalent 20/32 or worse

排除标准

  • History or presence of any of the following:
  • macular hole
  • previous vitreoretinal surgery
  • any other retinal pathology that could affect anatomic or functional results
  • Age Related Macular Degeneration
  • Diabetic Retinopathy
  • Diabetic Macular Edema
  • Retinal Vein Occlusion
  • Pre-existing Macular Disease

研究组 & 干预措施

PPV + MP + DEX

Experimental

Patients will undergo pars plana vitrectomy, membrane peel, and concomitant Ozurdex implant (0.7 mg dose).

干预措施: Dexamethasone Intravitreal Implant (Drug)

PPV + MP

Active Comparator

Patients will undergo pars plana vitrectomy with membrane peel, without Ozurdex implant.

干预措施: Dexamethasone Intravitreal Implant (Drug)

结局指标

主要结局

Changes in best corrected visual acuity

时间窗: 6 months

At all study visits: ETDRS visual acuity will be measured visit excluding post op day 1 (snellen visual acuity will be measured). Intraocular pressure (IOP) will be checked. Spectral Domain Optical Coherence Tomography (OCT). Dilated fundus exam. At Pre Op, Post Op Week 4, 8, 12, 16, 20 and 24 visits: ETDRS visual acuity will be measured. IOP check. Spectral Domain OCT. Fundus photography. Fundus Autofluorescence (AF). Fluorescein Angiography (FA). Dilated Fundus exam.

次要结局

  • Incidence of persistent macular edema on Central OCT thickness in treatment (PPV + MP + DEX) versus non-treatment (PPV + MP) groups(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rhonda Weeks

Gaurav K. Shah, MD

Barnes Retina Institute

研究点 (3)

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