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临床试验/NCT00540930
NCT00540930Unknown4 期

A Randomized Control Trial of Intravitreal Ranibizumab (Lucentis) for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy for Choroidal Melanoma

Shields, Shields and Associates2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2007年4月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
发起方
入组人数
400
试验地点
2
主要终点
Presence or absence of optical coherence (OCT) evidence of macular edema.

研究概览

简要总结

Uveal Melanoma is the most common primary intraocular malignancy in adulthood. Eye preserving treatments can deliver equivalent life prognosis in the management of small and medium sized uveal melanomas, as compared to enucleation. Plaque radiotherapy has emerged as the most common eye-preserving treatment in the current management of uveal melanoma, but is complicated by visual loss in approximately 70% of patients at 10 years follow-up. Strategies for the prevention and early treatment of radiation retinopathy/maculopathy need to be developed to improve visual outcomes following plaque treatment. Ranibizumab (Lucentis) is the antigen binding fragment of a recombinant, humanized monoclonal antibody, which inhibits the activity of vascular endothelial growth factor A, a mediator in the development of choroidal neovascularization. Lucentis is commonly used in the eye for eye conditions such as age related macular degeneration. This study will investigate the possible benefit of Anti-VEGF therapy (Lucentis) in reducing the incidence of radiation complications following plaque radiation for uveal melanoma.

研究设计

研究类型
Interventional
分配方式
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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years
  • new diagnosis of choroidal melanoma
  • scheduled for plaque radiotherapy at Wills Eye Health System

排除标准

  • Pre-existing retinal disorders (i.e. age-related macular degeneration, diabetic maculopathy, retinal vascular occlusion, macular hole, surface wrinkling retinopathy)
  • prior retinal detachment
  • media opacities precluding accurate OCT imaging
  • history of glaucoma
  • pregnancy
  • age <18 years.

结局指标

主要结局

Presence or absence of optical coherence (OCT) evidence of macular edema.

时间窗: 4 months

次要结局

  • Grade of macular edema on OCT, visual acuity (LogMAR), and foveal thickness measurement on OCT at follow-up.(4 months)

研究者

发起方
Shields, Shields and Associates
申办方类型
Other

研究点 (2)

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