Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
1/2期
进行中（已停止招募）
NCT02286089
| 适应症 | Age-Related Macular Degeneration |
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| 分期 | 1/2期 |
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| 申办方 | Hoffmann-La Roche |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 24 人 |
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| 干预（药物） | OpRegen |
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| 开始日期 | 2015年4月1日 |
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| 完成日期 | 2021年12月31日 |
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| 结果公布日 | 2023年3月6日 |
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摘要
The main objective of the study is evaluation of the safety and tolerability of OpRegen - Human embryonic stem cell-derived retinal pigment epithelial (RPE) cells. The study will also include initial exploration of the ability of transplanted OpRegen cells to engraft, survive, and moderate disease progression.
Percentage of Participants With Treatment Emergent Adverse Events
From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) · percentage of participants
| Cohort 1 | 33.3 percentage of participants |
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| Cohort 2 | 33.3 percentage of participants |
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| Cohort 3 | 0 percentage of participants |
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| Cohort 4 | 8.3 percentage of participants |
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| Cohort 1 | 33.3 percentage of participants |
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| Cohort 2 | 0 percentage of participants |
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Change From Baseline in Intraocular Pressure (IOP)
Baseline, Month 12 · mmHg
| Cohort 1 | 13.3 ± 2.3 mmHg |
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| Cohort 2 | 14.0 ± 0.0 mmHg |
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| Cohort 3 | 13.7 ± 3.7 mmHg |
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| Cohort 4 | 14.6 ± 3.1 mmHg |
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| Cohort 1 | 1.0 ± 2.6 mmHg |
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| Cohort 2 | 1.0 ± 1.7 mmHg |
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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。