Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
Phase 1/2
Active, not recruiting
NCT02286089
| Condition | Age-Related Macular Degeneration |
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| Phase | Phase 1/2 |
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| Sponsor | Hoffmann-La Roche |
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| Status | Active, not recruiting |
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| Enrollment | 24 participants |
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| Interventions | OpRegen |
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| Start date | Apr 1, 2015 |
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| Completion date | Dec 31, 2021 |
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| Results posted | Mar 6, 2023 |
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Summary
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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Open in BENITIONS
View on ClinicalTrials.gov
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