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Stem Cell Therapy

OpRegen for Age-Related Macular Degeneration

Phase 1 & 2

Waitlist Available

Led By Tareq Jaouni, MD

Research Sponsored by Lineage Cell Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of dry (non-neovascular) age related macular degeneration in both eyes

Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 12

Awards & highlights

Study Summary

This trial is testing a new stem cell treatment for retinal pigment epithelium (RPE) cells, to see if it is safe and effective.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed here, potential risks may include those associated with vitreoretinal surgery under anesthesia such as infection or bleeding inside the eye. There could also be immune reactions since OpRegen involves transplanting foreign biological material.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I can have eye surgery with anesthesia monitoring.

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I have advanced dry age-related macular degeneration with significant vision loss.

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I am 50 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change From Baseline in Intraocular Pressure (IOP)

Percentage of Participants With Treatment Emergent Adverse Events

Secondary outcome measures

Change From Baseline in Geographic Atrophy (GA) Lesion Area

Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Quality of Life

Change From Baseline in Visual Acuity

Trial Design

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

0 / 4Eligibility criteria met