A Study of Disease Progression in Genetically Defined Subjects With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 83
- 试验地点
- 71
- 主要终点
- Monocular and Binocular Reading Performance
研究概览
简要总结
An observational study to evaluate the natural progression of dry AMD in genetically defined subjects
详细描述
Prospective, observational study to evaluate the natural progression of anatomical and functional visual parameters in genetically defined subjects with GA due to AMD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with unilateral or bilateral Geographic Atrophy (GA) due to Age-related Macular Degeneration (AMD)
- •BCVA of 40 letters or better using ETDRS charts
排除标准
- •Evidence or history of neovascular Age-related Macular Degeneration (AMD) or diabetic retinopathy
- •Significant ocular or non-ocular disease that would impact the subject's ability to participate in the study
- •Participation in another research study involving an investigational product within the previous 4 weeks or 5 half-lives whichever is longer from the screening/baseline OR received a gene/cell therapy at any time previously
结局指标
主要结局
Monocular and Binocular Reading Performance
时间窗: Up to 96 weeks
Change in Monocular and Binocular Reading Performance measured in words/min
Geographic Atrophy (GA)
时间窗: Up to 96 weeks
Change from baseline in area of Geographic Atrophy, as assessed by Fundus Auto Fluoresence measured in mm2
Retinal Drusen Volume
时间窗: Up to 96 weeks
Change from baseline in retinal drusen volume measured in mm3
Colour Fundus (CF)
时间窗: Up to 96 weeks
Change from baseline in Colour Fundus Photography measured in mm2
Retinal sensitivity
时间窗: Up to 96 weeks
Change from baseline in retinal sensitivity as assessed by microperimetry
Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)
时间窗: Up to 96 weeks
Change from baseline in ETDRS BCVA reading score
Medical Events of Interest (MEI)
时间窗: Up to 96 weeks
Change from baseline in percentage of Participants with MEI
Visual Functioning Questionnaire
时间窗: Up to 96 weeks
Change from baseline in National Eye Institute Visual Functioning Questionnaire 25-Items Version (NEI VFQ-25) Minimum Score (Best) = 29. Maximum score (Worst) = 149
次要结局
未报告次要终点