Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
Фаза 1/2
Идёт, набор закрыт
NCT02286089
| Заболевание | Age-Related Macular Degeneration |
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| Фаза | Фаза 1/2 |
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| Спонсор | Hoffmann-La Roche |
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| Статус | Идёт, набор закрыт |
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| Участники | 24 участн. |
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| Вмешательство | OpRegen |
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| Дата начала | 1.04.2015 |
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| Дата завершения | 31.12.2021 |
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| Публикация результатов | 6.03.2023 |
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Кратко
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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