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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
Must not have
Evidence of neovascular AMD by history, as well as by clinical exam, fluorescein angiography (FA), or ocular coherence tomography (OCT) at baseline in either eye
History of retinal detachment repair in the study eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 12
Awards & highlights
Summary
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.
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.
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.
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 belowSelect...
I have been diagnosed with dry age-related macular degeneration in both eyes.
Select...
I can have eye surgery with anesthesia monitoring.
Select...
I have advanced dry age-related macular degeneration with significant vision loss.
Select...
I am 50 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with wet AMD in at least one eye.
Select...
I have had surgery to fix a detached retina in one eye.
Select...
My eye condition is only due to AMD, not other causes like myopia or histoplasmosis.
Select...
I cannot receive systemic immunosuppression.
Select...
I do not have significant eye diseases other than AMD that could affect my vision.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants With Treatment Emergent Adverse Events
Secondary study objectives
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Age-Related Macular Degeneration (AMD) include anti-VEGF (vascular endothelial growth factor) injections, photodynamic therapy, and stem cell-based therapies like OpRegen. Anti-VEGF injections work by inhibiting the growth of abnormal blood vessels that can leak and cause vision loss.
Photodynamic therapy uses light-activated drugs to destroy these abnormal vessels. Stem cell-based therapies, such as OpRegen, involve transplanting human embryonic stem cell-derived retinal pigment epithelial (RPE) cells to replace damaged RPE cells, aiming to restore and maintain retinal function.
These treatments are crucial for AMD patients as they target the underlying causes of vision loss, potentially slowing disease progression and preserving vision.
Find a Location
Who is running the clinical trial?
Lineage Cell Therapeutics, Inc.Lead Sponsor
4 Previous Clinical Trials
60 Total Patients Enrolled
CellCure Neurosciences Ltd.UNKNOWN
Hoffmann-La RocheLead Sponsor
2,447 Previous Clinical Trials
1,094,950 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with dry age-related macular degeneration in both eyes.Your vision in the eye that has not had surgery must be as good as or better than the eye that has had surgery.I am 50 years old or older.I can have eye surgery with anesthesia monitoring.I have no cancer history except for non-melanoma skin cancer, or any cancer I had is in remission for over 5 years with approval.I have been diagnosed with wet AMD in at least one eye.I have had surgery to fix a detached retina in one eye.I had cataract surgery over 2 months ago and no recent eye surgeries.I had cancer other than non-melanoma skin cancer, cured over 5 years ago, with approval.I understand the study and agree to participate.My eye condition is only due to AMD, not other causes like myopia or histoplasmosis.I have no cancer history except for non-melanoma skin cancer, or any cancer I had is in remission for over 5 years with approval.I am healthy enough to follow all study procedures and complete the study.I have advanced dry age-related macular degeneration with significant vision loss.I am healthy enough to follow all study procedures and complete the study.I cannot receive systemic immunosuppression.I am 50 years old or older.I am taking aspirin or blood thinners that I can't stop a week before surgery.I do not have significant eye diseases other than AMD that could affect my vision.I can have eye surgery with anesthesia monitoring.
Research Study Groups:
This trial has the following groups:- Group 1: OpRegen
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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