NCT04868916已完成不适用
Prospective Observational Study to Estimate the Genotype and Phenotype of Japanese Patients With X-linked Retinitis Pigmentosa Associated With Pathogenic Variants in Retinitis Pigmentosa GTPase Regulator (RPGR)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Visual Function
研究概览
简要总结
The purpose of the study is to identify a cohort of Japanese participants with X-linked retinitis pigmentosa (XLRP) associated with pathogenic variants in the retinitis pigmentosa GTPase regulator (RPGR) gene and to investigate their associated phenotype.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have RPGR-associated retinal dystrophy
- •Are able to give informed consent or assent, with the guidance of their parent/guardian where appropriate
- •Are able to undertake age-appropriate clinical assessments as specified in the protocol
排除标准
- •Are unable or unwilling to undertake consent or clinical testing
- •Participated in another research study and had intraocular surgery within 3 months of screening
- •Significant ophthalmologic diseases
结局指标
主要结局
Visual Function
时间窗: Up to Day 30
Visual function will be assessed using visual acuity.
Retinal Structure
时间窗: Up to Day 30
Retinal structure will be assessed using spectral domain optical coherence tomography (SDOCT).
Retinal Function
时间窗: Up to Day 30
Retinal function will be assessed using static visual field testing.
次要结局
未报告次要终点
研究者
研究点 (1)
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