NL-OMON52960已完成不适用
A Study of Disease Progression in Genetically Defined Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration - GTSCOPE study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Inclusion Criteria:, 1. Aged >=18 years, 2. Able and willing to give consent to
- •study participation, 3. Presence of unilateral or bilateral GA due to AMD, 4.
- •The GA lesion in at least one eye must reside completely within the FAF image,
- •5. For Group 1, subjects will be required to have a serum CFI level below the
- •lower limit of the assay together with a
- •rare genetic variant of the CFI gene OR for Group 2, subjects will have a
- •genetic variant of a complement factor
- •gene and do not qualify for Group 1, 6. Able to attend all study visits and
- •complete the study procedures, 7. BCVA of 40 letters or better using ETDRS
- •charts in the eye that meets inclusion criterion 3
排除标准
- •Exclusion Criteria:, 1. Evidence or history of neovascular AMD or diabetic
- •retinopathy; previous intravitreal drug delivery
- •[either eye] received within 4 weeks or 5 half-lives whichever is longer,
- •before screening/baseline visit, 2. Any other significant ocular or non-ocular
- •disease/disorder which, in the opinion of the investigator,
- •may influence the results of the study, or the subject*s ability to
- •participate in the study, 3. 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 visit OR
- •received a gene/cell therapy at
- •any time previously
研究者
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