NL-OMON22976尚未招募不适用
Prospective study on safety and efficacy of gene therapy with voretigene neparvovec (Luxturna®) in patients with RPE65-associated inherited retinal degenerations
The Rotterdam Eye Hospital0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 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
- Observational non invasive
入排标准
入选标准
- •Be able to cooperate.
- •- Informed consent.
- •- Clinical diagnosis of IRD with confirmed bi-allelic RPE65 mutations.
- •- Clinical evidence of viable retinal tissue (RPE cells, photoreceptors, and downstream ganglion cells) as target. Patients have to have more than one
- •characteristic:
- •1. total retinal thickness > 100 µm in the posterior pole (OCT).
- •2. area without atrophy of at least three disc diameters (funduscopy).
- •3. residual island in the central visual field (within 30º of central fixation; Goldmann).
- •- Recordable FST.
- •- Scheduled to receive treatment with Luxturna®.
排除标准
- •- None specified.
研究者
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