EUCTR2021-000265-33-NL进行中（未招募）1 期
Prospective study on safety and efficacy of gene therapy with voretigene neparvovec (Luxturna®) in patients with RPE65-associated inherited retinal degenerations - Luxturna follow-up
The Rotterdam Eye Hospital0 个研究点目标入组 20 人开始时间: 2021年1月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（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
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Informed consent.
- •- Clinical diagnosis of inherited retinal disease 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 full-field stimulus test.
- •- Scheduled to receive treatment with Luxturna®.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- None specified.
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