EUCTR2008-008720-33-BE进行中（未招募）不适用
A one year, open, prospective study on the role of quarterly intravitreal injections of Lucentis 0,5 mg (ranibizumab) in preventing of delaying progression of radiation retinopathy in eyes treated with Iodine 125 plaque radiotherapy for posterior uveal melanoma</full-title-trial
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male of female patients above 18 years of age who have signed an informed consent
- •The eye received Iodine 125 plaque radiotherapy for posterior uveal melanoma 12 months ago with tumor apex dose of 75 Gy
- •Tumor characteristics at the time of treatment of the melanoma 12 months ago :
- •- posterior uveal melanoma without ciliary body and iris involvement
- •- tumor posterior margins lower or equal to 3 mm to the fovea
- •- largest tumor diameter equal or above 10 and 16 mm
- •- tumor thickness equal or above 4 mm and equal or lower than 8 mm
- •- radiation doses rate of greater than 260 cGy /h to the tumor base
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with diabetes type I and II
- •Active intraocular inflammation in either eye
- •Any active infection (i.e. conjunctivitis, keratitis, scleritis, uveitis, endophtalmitis) in either eye
- •Ocular conditions that require chronic concomitant therapy with systemic or topical ocular corticosteroïd
- •Following ocular disorders in the study eye are not allowed : branch retinal vein occlusion, branch retinal arterial occlusion, vitreous hemorrhage, and choroïdal neovascularisation of any cause (e.g.AMD, ocular histoplasmosis, or pathologic myopia)
- •Presence of macular subretinal fluid documented by OCT
- •Neovascular glaucome in the study eye
- •Known hypersensitivity to ranibizumab or any component of the formulation
- •Pregnant or nursing women
- •Inability to comply with study of follow-up procedure
- •Women of child-bearing potential
研究者
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