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ACTIVE NOT RECRUITING
NCT02286089
PHASE1/PHASE2

Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2015-04-01

Completion Date

2031-01-31

Last Updated

2026-01-29

Healthy Volunteers

No

Interventions

BIOLOGICAL

OpRegen

Targeted dose of 50,000 - 200,000 cells will be delivered into the subretinal space.

Locations (7)

West Coast Retina Medical Group

San Francisco, California, United States

Cincinnati Eye Institute

Cincinnati, Ohio, United States

Mid Atlantic Retina

Philadelphia, Pennsylvania, United States

Hadassah Medical Center

Jerusalem, Israel

Rabin Medical Center

Petah Tikva, Israel

Kaplan Medical Center

Rehovot, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel