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Stem Cell Therapy
Stem Cell Transplant for Age-Related Macular Degeneration
Phase 1 & 2
Recruiting
Led By Henry E Wiley, M.D.
Research Sponsored by National Eye Institute (NEI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must be 55 years of age or older
Study eye must meet specific criteria including geographic atrophy and visual acuity requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12, 24, and 60 month
Awards & highlights
Study Summary
This trial is testing if it is safe to put cells in people's eyes as a possible future treatment for dry age-related macular degeneration. People who have had "wet" macular degeneration in either eye are not eligible.
Who is the study for?
This trial is for people over 55 with geographic atrophy from dry age-related macular degeneration, causing vision loss. Participants must have certain levels of visual acuity and be able to undergo surgery and follow-up visits. Pregnant individuals or those with 'wet' macular degeneration are excluded.Check my eligibility
What is being tested?
The safety of transplanting lab-grown retinal cells into the eye is being tested as a treatment for dry age-related macular degeneration. Patients will receive these new cells through a surgical procedure in one eye, followed by extensive monitoring over several years.See study design
What are the potential side effects?
Potential side effects may include discomfort from the various tests, risks associated with eye surgery such as infection or bleeding, possible reaction to anesthesia, and long-term unknown effects of having transplanted stem cell-derived tissue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 55 years old or older.
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My study eye has a specific type of retina damage and meets the vision sharpness requirements.
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I have been diagnosed with AMD in at least one eye.
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My study eye is clear and has an artificial lens or no lens.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12, 24, and 60 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12, 24, and 60 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Multifocal electroretinography responses
Retinal Structure (color and autofluorescence imaging)
Retinal Structure (optical coherence tomography)
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Participants receiving interventionExperimental Treatment1 Intervention
Participants receiving intervention
Find a Location
Who is running the clinical trial?
National Eye Institute (NEI)Lead Sponsor
546 Previous Clinical Trials
1,401,908 Total Patients Enrolled
Henry E Wiley, M.D.Principal InvestigatorNational Eye Institute (NEI)
5 Previous Clinical Trials
171 Total Patients Enrolled
Shilpa M Kodati, M.D.Principal InvestigatorNational Eye Institute (NEI)
5 Previous Clinical Trials
697 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 55 years old or older.My study eye has a specific type of retina damage and meets the vision sharpness requirements.I am not willing or able to agree to participate in this or future studies.I have been diagnosed with AMD in at least one eye.I have conditions that make using steroids or immune treatments risky.My cancer diagnosis may impact my survival over the next two years.I have taken medication that could harm my eyes in the last year.My family has a history of eye diseases other than age-related macular degeneration.My study eye does not have conditions like neovascularization, glaucoma, or a history of eye surgery.My study eye is clear and has an artificial lens or no lens.I can attend all required study visits and follow the treatment plan.
Research Study Groups:
This trial has the following groups:- Group 1: Participants receiving intervention
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we still enrolling people in this clinical trial?
"Yes, this study is still recruiting patients according to the latest information on clinicaltrials.gov. The trial was originally posted on September 23rd 2020 but has been updated as recently as August 13th 2022."
Answered by AI
How many participants are being allowed in this clinical trial?
"That is correct. The clinicaltrials.gov website notes that this research project is still recruiting individuals. This study was originally advertised on September 23rd 2020 with the latest update being on August 13th 2022. Right now, they are looking for 20 more participants and only have 1 site open."
Answered by AI
What are the main goals that we hope to achieve with this experiment?
"The team conducting this trial will be evaluating the success of the intervention by measuring the Summary of adverse events over 12, 24, and 60 months. Additionally, they will also be looking at Retinal sensitivity and fixation (microperimetry), Retinal Structure (optical coherence tomography), and Retinal structure (fluorescein angiography) as safety and efficacy measures."
Answered by AI
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