Characteristic Analysis of Retinopathy Associated With High Doses of Interferon α-2b Therapy in Patients With Melanomas of the Skin
试验速览
- 阶段
- 不适用
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change of ocular fundus after high doses of interferon α-2b therapy at the 1st week.
研究概览
简要总结
The high doses of interferon α-2b therapy in patients with melanomas of the skin may induced retinopathy, especially in the patients with hypertension or diabetes, so these patients should be followed up after treatment.
详细描述
Patients with melanomas of the skin whose tumors have been resected completely were collected. The detailed ocular examinations including intraocular pressure, slit lamp microscope, indirect ophthalmoscope and color fundus photography were done before the induction therapy, 2 weeks after the induction therapy, after the whole course of induction therapy and each month in the maintenance treatment period. Fundus examinations were carried out by experienced ocular fundus doctors and the retinopathy characteristics were recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, at least 18 years of age.
- •ECOG performance status 0 or
- •Patients must have histologically confirmed stage IB to stage III primary melanoma of cutaneous origin (AJCC 7th edition classification).
- •Must complete all primary therapy (wide excision with or without lymphadenectomy).
排除标准
- •Mucous membrane or ocular melanoma.
- •Any evidence of distant metastasis (CT-scan of brain, Chest X ray or CT, abdominal ultrasound or CT and ultrasound of regional lymph nodes at screening).
- •Patients with retinopathy on baseline fundoscopic examination at the start of interferon therapy.
- •History of any other malignancy within the last ten years (except basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix).
- •Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina), severe liver disease or severe renal disease.
- •Patients who have a history of depression or other psychiatric diseases requiring hospitalisation.
- •History or presence of autoimmune disease (i.e. autoimmune hepatitis, thyroid auto-immune dysfunction, systemic lupus erythematodes),
- •Unwilling or unable to comply with the requirements of the protocol for the duration of the study.
结局指标
主要结局
Change of ocular fundus after high doses of interferon α-2b therapy at the 1st week.
时间窗: the 1st week
次要结局
未报告次要终点