Treatment Of Radiation Retinopathy Trial Subtitle: Treatment of Radiation Retinopathy; Influence of Lucentis® and Kenalog® on Radiation Retinopathy After Irradiation of Choroidal Melanoma.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 220
- 主要终点
- To demonstrate a statistically significant superiority of intravitreal ranibizumab (0.5mg) or triamcinolone acetonide (4.0mg) to no treatment, in the mean change from baseline in best corrected visual acuity (BCVA)
研究概览
简要总结
The purpose of this study is to demonstrate a statistically significant improvement of visual acuity after treatment using either Lucentis® or Triamcinolone® compared to no treatment, in patients with radiation retinopathy.
详细描述
Approximately 30-40% of patients develop a deterioration of visual acuity within 5 years after treatment of uveal melanoma using radiation therapy and TTT due to radiation retinopathy (Shields 2002, Bartlema 2003). By administration of either Lucentis® or Triamcinolone® we hope to treat complications of radiation therapy, by demonstrating a statistically significant improvement in visual acuity and a reduced amount of macular edema and vascular leakage. Additionally, we hope to obtain a better understanding of the pathophysiologic processes involved, by demonstrating a possible relation between high levels of angiogenic factors (VEGF) in the anterior chamber fluid, and radiation retinopathy. In conclusion, we hope to provide evidence for a new therapy in patients with retinopathy, due to radiation in uveal melanoma. There is no scientifically proven treatment available at this time.
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
- Single (Participant)
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
- •The eye was previously irradiated for treatment of a uveal melanoma;
- •Decrease of visual acuity after irradiation therapy by more than 10 letters (ETDRS) and is now 20/40 or less;
- •Vision decrease is considered to be due to central radiation retinopathy with significant macular edema or optic disc edema;
- •Age 18 years or older;
- •The patient is fully competent;
- •Written informed consent to participate in the trial is given.
- •Patient is not pregnant (or not fertile) and is willing to use contraceptives for the duration of the trial (one year)
- •Patient is willing and able to return for follow-up.
排除标准
- •Vision decrease is considered to be due to ischemic radiation retinopathy without macular edema or optic disc edema;
- •Other, approved therapy indicated for treatment of condition;
- •Presence of metastasis;
- •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial;
- •Pre-existing retinopathy due to other disorders;
研究组 & 干预措施
1: Lucentis
干预措施: ranibizumab (Drug)
2: Kenalog
干预措施: triamcinolone acetonide (Drug)
3: No treatment
干预措施: sham (Other)
结局指标
主要结局
To demonstrate a statistically significant superiority of intravitreal ranibizumab (0.5mg) or triamcinolone acetonide (4.0mg) to no treatment, in the mean change from baseline in best corrected visual acuity (BCVA)
时间窗: one year
次要结局
- To evaluate the time course of BCVA changes on ranibizumab (0.5 mg) and triamcinolone acetonide (4.0mg) relative to no treatment.(one year)
- To evaluate the effects of ranibizumab (0.5 mg) and triamcinolone acetonide (4.0mg) on central retinal thickness, severity of retinopathy and other anatomical changes relative to no treatment(one year)
- To demonstrate a possible relation between decreasing levels of angiogenic factors (such as VEGF) in the anterior chamber fluid and a good response to treatment with ranibizumab or triamcinolone acetonide, and radiation retinopathy(4 weeks)