At a glance
ClinicalIndex Comparison RecordPhase 2Active· 24 enrolled
Drug / intervention
OpRegenbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/IIa Dose Escalation Safety and Efficacy Study of Human Embryonic Stem Cell-Derived Retinal Pigment Epithelium Cells Transplanted Subretinally in Patients With Advanced Dry-Form Age-Related Macular Degeneration (Geographic Atrophy)
In Brief
A Phase 2 clinical trial evaluating OpRegen for Age-Related Macular Degeneration. Active but no longer recruiting, targeting 24 participants across 7 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAge-Related Macular Degeneration
CountriesIsrael, United States
Collaborators--
Timeline
Phase 2Active
20152016201720182019202020212022202320242025202620272028202920302031
First PostedNov 2014
Enrollment StartApr 2015
Primary CompletionDec 2021
TodayJul 2026
Study CompletionJan 2031
First PostedNov 7, 2014
Enrollment StartApr 1, 2015
Primary CompletionDec 31, 2021
Study CompletionJan 31, 2031
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 11.7 years ago
Interventions
OpRegenbiological
Targeted dose of 50,000 - 200,000 cells will be delivered into the subretinal space.