Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
National Eye Institute (NEI)
Study ID
NCT04339764
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • iPSC-derived RPE/PLGA transplantation — DRUG
    iPSC-derived RPE/PLGA transplantation

Study Details

Background: Age-related macular degeneration is a common eye disease in people over 50. The "dry" form of the disease can worsen into geographic atrophy, causing blind spots. Researchers want to learn if replacing older eye cells with younger ones can help treat this disease. Objective: To test the safety of putting cells inside the eye as a possible future treatment for dry age-related macular degeneration. Eligibility: People ages 55 and older who have geographic atrophy with loss of vision. People who have had "wet" macular degeneration in study eye are NOT eligible. Design: Participants will be screened with: * Medical history * Physical exam * Blood and urine tests * Eye exam * Eye photos * Fluorescein angiography. An intravenous (IV) line is placed in an arm vein. A dye is injected. A camera takes pictures of the dye as it flows through the eyes' blood vessels. * Electroretinography. An electrode is taped to participants' forehead. They sit in the dark. After 30 minutes, numbing eye drops and contact lenses are placed in their eyes. They watch flashing lights. * Tuberculosis test * Chest X-ray * Electrocardiography. Sticky pads are placed on participants' chest to record the heart's electrical activity. Participants will have at least 14 study visits over 5 and a half years. They will repeat screening tests. Participants will have retinal pigment epithelium (RPE) transplantation surgery in one eye. For this, cells from participants' blood are turned into RPE cells. These cells are placed in their eye through a cut in their retina. They will get dilating eye drops, an IV line, and anesthesia that may make them sleep. A gas bubble will be put in their eye to help it heal. Participants will receive immunosuppressive medications to avoid transplant rejection. Participants will be contacted yearly for up to 15 years.

Key Dates

Start date
Sep 23, 2020
Status verified
Jan 2026
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants receiving intervention
    Participants receiving intervention

Primary Outcome Measure

Summary of adverse events [ Time Frame: 12 months compared to final Baseline prior to surgery ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21205
Mais Hamdawi
[email protected]
410-343-9434
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

Find similar trials in Baltimore, MD

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Johns Hopkins University· Baltimore, MDNational Institutes of Health Clinical Center· Bethesda, MD

Related Studies