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临床试验/NCT00391144
NCT00391144Unknown2 期

Intravitreal Avastin Injection for the Treatment of Choroidal Neovascularization Secondary to Pattern Dystrophy

University of Trieste2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2006年7月最近更新:
适应症

试验速览

阶段
2 期
入组人数
5
试验地点
2
主要终点
number of eyes with <15 letter loss (approximately <3 lines) at 6-month examination compared with the baseline value

研究概览

简要总结

The natural history of subfoveal CNV secondary to Pattern Dystrophy is little understood, but it seems that visual function may be preserved only in the short-term follow-up, with progressive deterioration thereafter.

Photodynamic therapy with verteporfin is the most studied therapeuthic option for this kindf of lesion, but unfortunately, this approach does not appear to guarantee long-term vision stabilization, and alternative therapies should be investigated.

详细描述

Diagnosis of Pattern Dystrophy Diagnosis of subfoveal CNV Intravitreal injection of avastin (1.25 mg) in operating room under sterile condition.

Retreatment on the basis of the detection of disease progression and of lack of central retinal thickness reduction on OCT.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of RPD (hyperpigmented yellowish-greyish network, other family members sharing RPD, normal electroretinogram and normal/subnormal electrooculogram)
  • classic or occult CNV involving the foveal avascular zone's geometric centre

排除标准

  • conditions other than RPD
  • intraocular surgery or capsulotomy within the last 2 or 1 months
  • pregnancy

结局指标

主要结局

number of eyes with <15 letter loss (approximately <3 lines) at 6-month examination compared with the baseline value

numeber of eyes with <15 letter loss at 12-month examinations, compared with the baseline value.

次要结局

  • CNV progression
  • number of injections.

研究者

申办方类型
Other

研究点 (2)

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