OpRegen for Age-Related Macular Degeneration

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen byTareq Jaouni, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Lineage Cell Therapeutics, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a new treatment using special cells from human embryos to help people with a type of vision loss called dry-AMD. The treatment involves injecting these cells into the eye to see if they can survive and slow down the disease.

Eligibility Criteria

This trial is for individuals aged 50 or older with advanced dry-form age-related macular degeneration (AMD) in both eyes. Participants must have a central visual acuity of 20/200 or worse, be in good health to undergo surgery and follow-up procedures, and not have any significant eye diseases other than AMD. They cannot have active infections like TB, HIV, hepatitis B/C, CMV IgM, EBV IgM or a history of certain cancers unless in remission for over five years.

Inclusion Criteria

I have been diagnosed with dry age-related macular degeneration in both eyes.

Best corrected central visual acuity equal or less than 20/200 in cohorts 1-3 and 20/64-20/250 in cohort 4 in the study eye by ETDRS vision testing

Vision in the non-operated eye must be better than or equal to that in the operated eye

+9 more

Exclusion Criteria

Any type of systemic disease or its treatment, in the opinion of the Investigator, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk

Current participation in another clinical study. Past participation (within 6 months) in any clinical study of a drug administered systemically or to the eye

I have been diagnosed with wet AMD in at least one eye.

+10 more

Participant Groups

The study tests the safety and effectiveness of OpRegen - cells derived from human embryonic stem cells intended to replace damaged retinal pigment epithelial (RPE) cells. It aims to see if these transplanted cells can integrate into the retina, survive long-term and slow down disease progression in patients with AMD.

1Treatment groups

Experimental Treatment

Group I: OpRegenExperimental Treatment1 Intervention

Up to 12 legally blind subjects with best corrected visual acuity of 20/200 or less in first three cohorts and 12 subjects with best corrected visual acuity of 20/64 and 20/250 in fourth cohort