Steroids for Early Treatment of Radiation Retinopathy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Central subfield retinal thickness by OCT scan
研究概览
简要总结
Radiation retinopathy is a known complication of ocular radiation therapy. To date there is no known effective treatment. In addition to their anti-vascular endothelial growth factor (VEGF) properties, corticosteroids decrease the retinal capillary permeability by increasing the activity/density of tight junctions and acute inflammatory effects of radiation in various tissues.
详细描述
The purpose of the project is threefold:
- To study the natural history of radiation retinopathy using advanced imaging techniques. A combination of macular OCT to evaluate for edema, OCT angiography to evaluate for macular and peri-papillary ischemia and wide-field angiography for peripheral ischemia and leakage. Potential role of OCT angiography in radiation retinopathy will be evaluated by comparison to other eye (control) and FA.
- Currently there is no consensus on effective management strategy for radiation retinopathy. Patients in the interventional will be prospectively followed to study efficacy of steroids for early treatment of radiation retinopathy while comparing the multimodal therapeutic approach in a randomized trial.
- Patients in the observational arm will be prospectively followed while comparing the multimodal therapeutic approach in a randomized trial.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary uveal melanoma
- •Primary treatment with plaque brachytherapy
- •Baseline visual acuity 20/200 or better
- •Posterior tumor margin >1.50 mm from the center of the macula
- •Posterior tumor margin > 1.50 mm from the closest disc margin
- •Calculated total dose to center of the macula >40 Gy
排除标准
- •Iris melanoma
- •Opaque media
- •less than 21 years of age
- •Inability to give consent
- •Positive pregnancy test
研究组 & 干预措施
Intervention
The study will only include those patients that are ascertained be at more than 50% risk for vision loss (20/200 or worse at 3 years) because of total radiation dose of >40 Gy to the center of the macula.1 These "at risk" patients included in the study will receive intravitreal triamcinolone (4 mg in 0.1 ml) injected at the time of plaque removal. If lack of IOP rise (30 mm Hg or more) at 3 months, then randomized to intravitreal Fluocinolone Acetonide (FA) implant.
干预措施: Fluocinolone Acetonide (FA) implant (Drug)
结局指标
主要结局
Central subfield retinal thickness by OCT scan
时间窗: 24 months
Anatomic outcome
次要结局
- Best corrected visual acuity(24 months)
研究者
Arun SINGH
Professor
The Cleveland Clinic