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NCT04339764 · ClinicalTrials.gov registry record · Phase 1
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
A Phase 1 study of Geographic Atrophy and Dry Age-Related Macular Degeneration, sponsored by National Eye Institute (NEI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT04339764 is a Phase 1 study of Geographic Atrophy and Dry Age-Related Macular Degeneration that is actively recruiting participants, run by National Eye Institute (NEI). The registered enrollment target is 20 participants, below the 221-participant average among 27 other Geographic Atrophy trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT04339764, a Phase 1 study of Geographic Atrophy and Dry Age-Related Macular Degeneration, is actively recruiting participants, sponsored by National Eye Institute (NEI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG iPSC-derived RPE/PLGA transplantation
Study Locations (2)
Maryland
- Johns Hopkins University - Baltimore
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-09-23 |
| Est. Completion | 2029-05-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04339764
The ClinicalTrials.gov registry entry for NCT04339764 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 27 other Geographic Atrophy trials with a reported enrollment target (91% lower). The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Geographic Atrophy appearing as the primary indexed condition, and to 1 intervention - of which iPSC-derived RPE/PLGA transplantation is the first listed.
NCT04339764 reports 2 study locations spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT04339764 about?
NCT04339764 is a clinical study titled "Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration". 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 t...
What is the current status of trial NCT04339764?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2020-09-23. Estimated completion is 2029-05-31.
What conditions does trial NCT04339764 study?
This clinical trial studies the following conditions: Geographic Atrophy, Dry Age-Related Macular Degeneration.
What interventions are being tested in trial NCT04339764?
The interventions under investigation include: iPSC-derived RPE/PLGA transplantation (DRUG).
Who is sponsoring clinical trial NCT04339764?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04339764 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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