Determining the Effect of Low-dose Isotretinoin on Proliferative Vitreoretinopathy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Rate of Retinal Attachment
研究概览
简要总结
Proliferative vitreoretinopathy (PVR), or secondary scarring on and around the retina, is an important cause of retinal re-detachment. The purpose of this study is to evaluate the effect of oral isotretinoin, which inhibits the growth of cells responsible for proliferative vitreoretinopathy (PVR), on recurrent retinal detachment.
详细描述
Small retrospective studies have shown isotretinoin to be effective in reducing the rate of recurrent retinal detachment in patients with or at high risk for developing PVR. This is a prospective study to evaluate a low dose of oral isotretinoin in this regard. There are two arms to the study: 1) eyes with recurrent retinal detachment due to existing PVR, and 2) eyes with primary detachment and features associated with a high risk of PVR formation. Eligible and willing patients will receive a 12-week course of isotretinoin, and will be followed for retinal attachment rate, and PVR and/or ERM (epiretinal membrane) formation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-70 year-old men or 50-70 year-old, post-menopausal women.
- •Healthy enough to participate in the study.
- •Willing and able to consent to participation.
- •Recurrent PVR-associated RD occurring at least 2 weeks after RD repair or
- •Primary RD (retinal detachment) associated with one or more high-risk features
排除标准
- •History of hypersensitivity to isotretinoin.
- •Current use of a corticosteroid (excluding topical).
- •Any history of depression, anorexia, liver or pancreatic disease.
- •More than one prior surgical RD repair.
- •Patients with closed funnel retinal detachments.
- •Patients with chronic retinal detachment, defined as longer than 12 weeks.
- •Any use an oral retinoid within 6 months.
- •Systemic chemotherapy within 6 months.
- •Patients taking supplemental vitamin A.
- •Corneal opacity sufficient to impair surgical view.
- •Proliferative diabetic retinopathy.
研究组 & 干预措施
Primary, high-risk retinal detachment
Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
干预措施: Isotretinoin (Drug)
Recurrent RD associated with PVR
Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
干预措施: Isotretinoin (Drug)
结局指标
主要结局
Rate of Retinal Attachment
时间窗: 3 months
We will evaluate all patients for retinal attachment at 3 months.
次要结局
未报告次要终点
研究者
Richard S. Kaiser
Associate Clinical Professor
Wills Eye