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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: Recruiting Phase 1 study of Geographic Atrophy and Dry Age-Related Macular Degeneration, sponsored by National Eye Institute (NEI).

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

safety measure

Conditions Studied

Geographic Atrophy Dry Age-Related Macular Degeneration

Interventions

  • DRUG iPSC-derived RPE/PLGA transplantation

Study Locations (2)

Maryland

  • Johns Hopkins University - Baltimore
  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2020-09-23
Est. Completion 2029-05-31
Phase Phase 1
National Eye Institute (NEI)

221 total trials

What NCT04339764 shows while recruiting

NCT04339764 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 221-participant average among 27 other Geographic Atrophy trials with a reported enrollment target (91% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Geographic Atrophy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04339764's enrollment target sits among peer trials

20 28th of 27 the lowest of 27 other Geographic Atrophy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Geographic Atrophy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04339764

Source: ClinicalTrials.gov NCT04339764, the US trial registry maintained by the National Library of Medicine. NCT04339764 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.